Source: National Drug Administration
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(January 22, 2020 announced the 27th of the State Administration of Market Supervision and Administration)
Chapter 1 Total
The first article Regulating drug registration behavior，Make sure the safety of the medicine、Effectiveness and quality controlled，According to the "Pharmaceutical Management Law of the People's Republic of China" (hereinafter referred to as the "Drug Management Law")、"The Chinese Medicine Law of the People's Republic of China"、"Vaccine Management Law of the People's Republic of China" (hereinafter referred to as the "Vaccine Management Law")、"Administrative License Law of the People's Republic of China"、"Implementation Regulations of the People's Republic of China" and other laws、Administrative Regulations，Formation of these measures。
Article 2 For the purpose of listing for drugs in the People's Republic of China，engaged in drug development、Registration and supervision and management activities，Applicable these Measures。
Article 3 Drug registration refers、Pharmaceutical listing license、Application for re -registration and other applications，Drug supervision and management department for security based on laws and regulations and existing scientific cognition、Examination of effectiveness and quality controllability，Decide whether to agree with the activity they applied for。
After the applicant obtains a drug registration certificate，The holder of the drug listing permit (hereinafter referred to as the holder)。
Article 4 Drug registration according to Chinese medicine、Chemical drugs and biological products for category registration management。
Chinese medicine registration according to Chinese medicine innovation medicine、New medicine improved Chinese medicine、Ancient classic famous Chinese medicine compound preparations、The same name of the same name is classified。
Chemical drug registration according to chemicals innovative drugs、New drugs for improving chemical drugs、Imitation drugs, etc. are classified。
Registration of biological products according to biological products innovative medicine、New drugs of improved biological products、Biological products (including biological similar medicines) have been classified。
Chinese medicine、Refined classification and corresponding application information requirements for chemical drugs and biological products，State Drug Administration based on the product characteristics of registered drugs、The degree of innovation and review management requires organization formulation，announcement to the society。
Registration application for overseas production drugs，Perform the requirements according to the refined classification of drugs and the corresponding application data requirements。
Article 5 The State Drug Administration is in charge of national pharmaceutical registration and management，Responsible for establishing a drug registration management working system and system，Formulate drug registration management specifications，Organize the approval of drug registration review and approval according to law and related supervision and management。The Drug Review Center of the State Drug Administration (hereinafter referred to as the Drug Review Center) is responsible for the application of drug clinical trials、Application for Pharmaceutical Listing License、Reviews of supplementary applications and re -registration applications for overseas production drugs。China Food and Drug Inspection Research Institute (hereinafter referred to as the Chinese Inspection Institute)、National Pharmacopoeia Committee (hereinafter referred to as the Pharmacopoeia)、Food and Drug Review and Inspection Center of the State Drug Administration (hereinafter referred to as the drug verification center)、Drug Evaluation Center of the State Drug Administration (hereinafter referred to as the drug evaluation center)、Administrative Matters Acceptance Service and Complaint Reporting Center、Information Center of the State Drug Administration (hereinafter referred to as information center) and other pharmaceutical professional and technical institutions，Drug registration inspection required for the implementation of drug registration management in accordance with the law、General name approval、Check、Monitoring and evaluation、Certificate delivery and corresponding information construction and management related work。
Article 6 Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government is responsible for the relevant management of drug registration in the administrative area:
(1) Acceptance of the application for re -registration of domestic production drugs、review and approval;
(2) File after the drug is listed、Report matters management;
(3) Organization research institutions for non -clinical safety evaluation of drugs、Daily supervision and investigation and punishment of the clinical trial institution of the drug;
(4) Participate in drug registration and verification organized by the State Drug Administration、Inspection and other tasks;
(5) Drug registration related matters entrusted by the State Drug Administration。
Provincial、Autonomous Region、The Drug Supervision and Management Department of the Municipality or a designated pharmaceutical professional and technical institution，Responsible for the review required for the implementation of drug supervision and management in accordance with the law、Test、Check、Monitoring and evaluation work。
Article 7 Drug registration management follows public、Fairness、Principles of Justice，guided clinical value，Encourage research and creation of new drugs，Actively promote the development of generic drugs。
The State Drug Administration continues to promote the reform of the review and approval system of review and approval，Optimized review approval procedure，Improve review and approval efficiency，Established to dominate the review，Test、Check、Drug registration management system supported by monitoring and evaluation。
Chapter 2 Basic System and Requirements
Article 8 engaged in drug development and drug registration activities，It should abide by relevant laws、Regulations、Regulations、Standards and specifications; refer to the relevant technical guidance principles，Using other evaluation methods and technologies，It shall prove its scientificity、Applicability; it should be guaranteed that the whole process information is true、Accurate、Complete and traceable。
Drugs should meet the national drug standards and the drug quality standards approved by the State Drug Administration。Drug quality standards approved by the State Drug Administration，Drug registration standard。Drug registration standards should meet the common technical requirements of the "Pharmacopoeia of the People's Republic of China"，It must not be lower than the provisions of the "Pharmacopoeia of the People's Republic of China"。Detective items or indicators for registration of registered varieties are not applicable to the "Pharmacopoeia of the People's Republic of China"，The applicant should provide sufficient support data。
Drug Review Center and other professional and technical institutions，It should be based on scientific progress、Industry development actual and drug supervision and management needs to formulate technical guidance principles and procedures，announcement to the society。
Article 9 The applicant shall be an enterprise or drug development institution that can bear the corresponding legal responsibility。Overseas applicants should designate corporate legal persons in China to handle related drug registration items。
Article 10 Applicants before applying for drugs，Pharmacy should be completed、Pharmacological toxicology and clinical trials of pharmaceuticals。Drug non -clinical safety evaluation research shall be carried out in institutions that have been certified by drug non -clinical research quality management specifications，and abide by the quality management specifications of drug non -clinical research。The clinical trial of the drug shall be approved，Among them, the trials of biological equivalent shall be filed; the clinical trials of the drug should be carried out in the drug clinical trial institution that meets relevant regulations，and obey the quality management specifications of drug clinical trials。
Prove the safety of the drug，Should be provided with real、Enough、Information and sample、Information and sample，Prove the safety of the drug、Effectivity and quality controllability。
Use overseas research data and data to support drug registration，its source、Research institutions or laboratory conditions、Quality System Requirements and other management conditions shall meet the principles of traffic in the coordination meeting of international drug registration technical requirements，and meet the relevant requirements of Chinese drug registration management。
Article 11 Change the original drug registration approval document and the matters or content stated in its attachments，The applicant shall be in accordance with regulations，Refer to the relevant technical guidance principles，Putting full research and verification of changes in drugs，Fully evaluate changes may be for drug safety、Effects of effectiveness and quality controllability，Application for supplementary applications in accordance with the change procedure、File or report。
Article 12 Drug registration certificate is valid for five years，The holder of the pharmaceutical registration certificate should continue to ensure the safety of the drugs for the public、Effectivity and quality controllability，and apply for medicines before the expiration of the validity period and register again。
Article 13 The State Drug Administration establishes drugs to accelerate the listing registration system，Supporting clinical value -oriented drug innovation。Application for registration of eligible drugs，Applicants can apply for applicable breakthrough therapeutic drugs、Conditional approval、Priority review approval and special approval procedures。During the development and registration of drugs，Drug Supervision and Administration Department and their professional and technical institutions give necessary technical guidance、Communication、Preferential allocation of resources、Shorten the time limit of review time and technical support。
Article 14 The State Drug Administration establishes chemicals and drugs、Accessories and directly contacting drug packaging materials and container association review approval systems。When approved the drug preparation，Review and approval of chemical raw materials，For related auxiliary materials、Packaged materials and containers who directly contact the drugs and container 1 and review。Pharmaceutical review center Establish chemicals and medicines、Accessories and container information registration platform，Publicly announced the relevant registration information，For relevant applicants or holders to choose，and Review of Review of Related Drug Preparation Application for Review。
Article 15 Classification registration and conversion management of prescription drugs and non -prescription drugs。Drug Review Center according to the characteristics of non -prescription drugs，Formulate the principles and procedures for technical guidance related technical guidance related to the market registration of non -prescription drugs，announcement to the society。Drug Evaluation Center formulates prescription drugs and non -prescription drugs to convey related technical requirements and procedures after listing，announcement to the society。
Article 16 Applicants before the application of drug clinical trials、During the clinical trial of the drug and the key stage of the drug listing permit，communication can be communicated with professional and technical institutions such as major issues with professional and technical institutions such as drug review centers。During the registration process of the drug，Drug Review Center and other professional and technical institutions can organize communication with the applicant according to the needs of the work。
Procedures for communication、Requirements and time limit，Formulated by professional and technical institutions such as the Drug Review Center in accordance with the functions，announcement to the society。
Article 17 Drug Review Center and other professional and technical institutions to establish an expert consultation system，Establishing an expert consulting committee，Review、Check、Test、During the approval of common names, hear the opinions of experts，Give full play to the technical support of the expert。
Article 18 The State Drug Administration establishes a newly approved listing and consistent evaluation of the quality and efficacy of generic drugs，Deliced drug name、Active ingredients、Dosage type、Specification、Whether it is a reference preparation、Holders and other related information，Update in time and disclose to the society。Chemical Drug Catalog Collection Collection Procedures and Requirements，Formulated by the Drug Review Center，announcement to the society。
Article 19 The State Drug Administration supports Chinese medicine inheritance and innovation，Establish and improve the registration management system and technical evaluation system that meets the characteristics of traditional Chinese medicine，Encourage the use of modern science and technology and traditional research methods to develop traditional Chinese medicine，Strengthen the quality control of Chinese medicine，Improve the level of clinical trials of traditional Chinese medicine。
Application of Chinese Medicine Registration，The applicant should conduct clinical value and resource evaluation，Highlighting clinical value -oriented，Promote the sustainable use of resources。
Chapter 3 Pharmaceutical Listing Registration
Section 1 Drug Clinical Test
Article 20 The clinical trial referred to this method refers to the purpose of the listing of drugs，Drug Studies to Determine Drug Safety and Effectiveness in the human body。
Article 21 Drug clinical trials are divided into phase I clinical trials、Phase II clinical trial、Phase III clinical trial、Phase IV clinical trial and biological equivalent test。According to the characteristics of the drug and research purpose，Research content includes clinical pharmacological research、Exploratory Clinical Test、Confirmation clinical trials and research after listing。
Article 22 Drug clinical trials shall be carried out at the drug clinical trial institution that has the corresponding conditions and records in accordance with the prescribed regulations。Where，The clinical trial of the vaccine shall be implemented or organized or organized by the National Drug Administration and stake online sports bettingstake sports betting appthe National Health and Health Commission.。
Article 23 The applicant completes the pharmacy that supports drug clinical trials、Pharmacology toxicology and other studies，Application for clinical trial applications for drugs，Research materials shall be submitted in accordance with the requirements of the application information。Examine on the form of menstruation，The application information meets the requirements，Give it to accept。Drug Review Center shall organize pharmacy、Medicine and other technical personnel will review the application for clinical trials of the acceptable drugs。Application for clinical trials of drugs shall be decided within 60 days from the date of acceptance.，and notify the applicant's approval results through the website of the Drug Review Center;，See Agree，Applicants can conduct clinical trials of drugs in accordance with the submitted plan。
The applicant's approved clinical trials of drugs are drug clinical trial applicants (hereinafter referred to as applicants)。
Article 24 The applicant intends to conduct a biological equivalent test，It shall complete the record filing of the biological equivalent test at the website of the Drug Review Center in accordance with the requirements，Carry out related research work according to the filing plan。
Article 25 Carry out the clinical trial of drugs，It should be reviewed and approved by the Ethics Committee。
The management of drugs for clinical trials of drugs shall meet the relevant requirements of the quality management specifications of drug clinical trials。
Article 26 Masched clinical trials for drugs，Applicants before the clinical trials of subsequent pharmaceuticals，The corresponding drug clinical trial scheme should be formulated，After reviewing and agreeing with the ethics committee，and submit the corresponding drug clinical trial scheme and support information at the website of the Drug Review Center。
Article 27 Drugs that have been allowed to carry out drug clinical trials to increase indications (or functional treatment) and increase with other drugs，The applicant shall submit a new drug clinical trial application，New drug clinical trials can be carried out after approval。
Drugs that are approved to be listed to increase indications (or functional indications) need to carry out drug clinical trials，It should be submitted to the application of new drug clinical trials。
Article 28 The applicant shall regularly submit the safety update report during the research and development period on the website of the Pharmaceutical Review Center。Safety Update Report during the R & D period shall be submitted once a year，Submit within two months after the clinical trial of the drug was obtained。Drug Review Center can be based on the review，Requires the applicant to adjust the report cycle。
Suspicious and non -expected serious adverse reactions and other potential safety risk information for the clinical trials of the drug，The applicant shall report to the Drug Review Center in a timely manner in accordance with the relevant requirements。According to the severity of safety risk，It can be required to take the applicant to adopt the clinical trial plan of the drug、Knowledge Agreement、Researchers' manual and other measures to strengthen risk control，If necessary, you can request the applicant to suspend or terminate the clinical trial of drugs。
The specific requirements of the Safety Update Report during the R & D period are formulated and announced by the Pharmaceutical Review Center。
Article 29 During the clinical trial of the drug，Change of the clinical trial plan of the drug、Non -clinical or pharmaceutical changes or new discoveries，The applicant shall be in accordance with regulations，Refer to the relevant technical guidance principles，Fully evaluate the impact of the safety of the subject。
The applicant's assessment believes that it does not affect the safety of the subject，It can be directly implemented and reported in the security update report during the development period。It may increase the safety risk of the subject，It should be submitted for supplementary applications。For supplementary applications shall decide whether to agree within 60 days from the date of acceptance，and notify the applicant's approval results through the website of the Drug Review Center;，See Agree。
Applicants have changed，The relevant responsibilities and obligations of the clinical trials of the drug after the changing applicants。
Article 30 During the clinical trial of the drug，Discovery to security issues or other risks，The applicant shall adjust the clinical trial plan in time、Passing or termination of clinical trials，Report to the Drug Review Center。
There is one of the following situations，It can be required to adjust the clinical trial plan of the drug、Parattery or termination of clinical trials:
(1) If the Ethics Commission has not fulfilled its duties;
(2) It cannot effectively guarantee the safety of the subject;
(3) The applicant did not submit the safety update report during the R & D period as required;
(4) The applicant did not deal with it in time and reported suspicious and unpredictable serious adverse reactions;
(5) There is evidence to prove that research drugs are invalid;
(6) Quality problems with drugs for clinical trials;
(7) During the clinical trials of the drug, fake;
(8) Other circumstances that violate the quality management specifications of clinical trials of drugs。
Drug clinical trials appear large -scale、Non -expected serious adverse reactions，or evidence to prove that there are serious quality problems in clinical trial drugs，Applicants and drug clinical trial institutions shall immediately stop the drug clinical trial。Drug supervision and management department can order clinical trial plan、Passing or termination of clinical trials of drugs。
Article 31 The clinical trial of the drug was ordered to be suspended，The applicant intends to continue the clinical trial of the drug，Supplementary applications for restoring clinical trials of drugs after completing the rectification，After the review and consent, it can continue to conduct clinical trials of drugs。Drug clinical trials have been suspended for three years and have not been applied for and are allowed to restore the clinical trials of the drug，This drug clinical trial permission will fail。
After the clinical trial of the drug is terminated，It is intended to continue the clinical trial of drugs，It should be re -proposed to apply for clinical trials of drugs。
Article 32 The clinical trial of the drug shall be implemented within three years after approval。The application of the clinical trial of the drug is from the date of obtaining the approved，No subject signed an informed consent form for three years，This drug clinical trial permission will fail。Still need to implement clinical trials of drugs，It should be re -apply。
Article 33 The applicant shall register the drug clinical trial plan of the drug clinical trial registration and the information clinical trial scheme of the drug clinical trial plan before conducting the clinical trial of the drug。During the clinical trial of the drug，The applicant should continue to update the registration information，and register information such as clinical trial results after the clinical trials of the drug。Registration information is publicized on the platform，The applicant is responsible for the authenticity of the drug clinical trial registration information。
The specific requirements of the clinical trial registration and information of the drug，Formulated by the Drug Review Center。
Section 2 Pharmaceutical License
Article 34 The applicant is completing pharmacology registered in the listing of drugs、Studies such as pharmacological toxicology and drug clinical trials，Determine the quality standard，Complete business scale production process verification，The applicant is completing pharmacology registered in the listing of drugs，Application for a drug listing permit，Submit related research materials in accordance with the requirements of the application information。After reviewing the application information，Meeting the requirements，Give it to accept。
Article 35 Imitation drugs、According to the in vitro diagnostic reagent and other eligible circumstances，Evaluation of the applicant，It is believed that there is no need to or cannot conduct clinical trials of drugs，Conditions that meet the clinical trials of the exemption of drugs，Applicants can directly submit a drug listing license application。The technical guidance principles and related requirements of the clinical trial of the drug and exemption，Formulated by the Drug Review Center。
The generic drug should be consistent with the quality and efficacy of the reference preparation。The applicant shall choose a reasonable reference preparation with reference to the relevant technical guidance principles。
Article 36 In line with one of the following circumstances，You can directly submit a license application for non -prescription drug listing:
(1) The same active ingredients in the territory、Indications (or functional Indications)、Dosage type、Specifications for non -prescription medicines for the market;
(2) A non -prescription drug change dosage or specifications determined by the State Drug Administration，But without changing indications (or functional Indications)、Drugs and medicines for dosage and administration;
(3) A new compound preparation composed of the active ingredients of non -prescription drugs determined by the State Drug Administration;
(4) Other situations for direct application for non -prescription drug listing permits。
Article 37 The common name of the drug to be used for the drug，Not included in national drug standards or drug registration standards，The applicant shall submit a general name approval application at the same time when submitting a drug listing license application。After the application of the drug listing permit is accepted，GM approval of the relevant information transfer ducts，GM approval of the relevant information transfer ducts。
The common name of the drug to be used for the drug to be used，It has been included in national drug standards or drug registration standards，Drug Review Center believes that during the review process, it is believed that the common name of the drug is required，shall notify the Pharmaceutical Code to check the general name and provide relevant information，GM approval of the relevant information transfer ducts。
When the Pharmaceutical Committee is approved by the common name of the drug，It should be communicated with the applicant，and inform the applicant with the results of the approval。
Article 38 Drug Review Center shall organize pharmacy、Medicine and other technical personnel，Application for the application for the acceptance of the acceptable drug listing permit as required。
During the review process, the drug registration verification based on risk was launched、Test，Related technical institutions shall complete the verification within the prescribed time limit、Test work。
Drug Review Center according to the registration of drug registration、Check the results、Test results, etc.，Safety of drugs、Effectability and quality controllability for comprehensive review，African prescription drugs should also be transferred to the drug evaluation center for non -prescription drug appropriate examination。
Article 39 Comprehensive review conclusion passed，Approve the listing of drugs，Send to the drug registration certificate。Comprehensive review conclusions are not passed，Make a decision not to be approved。Drug Registration Certificate Prefecture Drug Approval Text、holder、Production enterprise and other information。Drug registration certificates for non -prescription drugs should also indicate the category of non -prescription drugs。
Approved drug production technology、Quality Standards、Manual and label as an attachment to the pharmaceutical registration certificate together to the applicant，If necessary, it should be attached to the research requirements after listing。The above information is included in the drug variety file，and update in time according to the change after listing。
After the drug is approved to be listed，The holder shall produce drugs in accordance with the production technology and quality standards approved by the State Drug Administration，and refine and implement in accordance with the requirements of the quality management of drug production。
Article 40 Drug Listing Application Application Review Period，The occurrence may affect the safety of drugs、Major changes in effective and quality controllability，The applicant shall withdraw the original registration application，Re -declaration after replenishment。
Applicants name change、Registration address name change, etc., which does not involve the content of the technical review，Should inform the Drug Review Center in time and submit relevant certification information。
Section 3 related review review approval
Article 41 Drug Review Center When applying for the registration of drug preparations，Chemicals selected for drug preparations、Accessories and container and containers that are directly exposed to drugs for related reviews。
Chemicals、Packaging materials and container manufacturers that are accessible and directly contacting drugs shall be in accordance with the requirements of the related review review and approval system，In chemical raw materials、Accessories and Packaging materials and container registration platform registration product information and research materials。Drug Review Center announced the registration number to the society、Product name、Enterprise name、Production address and other basic information，Registered applicants for drug preparations。
Article 42 Drug Preparation Applicants propose a drug registration application，You can directly select the registered chemicals、Accessories and containers and containers that are directly exposed to drugs; choose unregistered chemicals、Accessories and container and container，Related research materials shall be declared with the application of the pharmaceutical preparation。
Article 43 Drug Review Center When applying for the registration of drug preparations，Chemicals selected for drug preparations、Accessories and container and containers that are directly exposed to drugs for related reviews，For supplementary information，Requires the drug preparation applicant or chemical raw material medicine in accordance with the supplementary data procedure、Supplementary materials and container registration enterprises that are directly exposed to drugs and container registration companies，It can be proposed based on risks to propose chemical raw materials、Accessories and container -containing materials and container companies that are directly exposed to drugs for extension inspection。
The chemical raw materials used in imitated drugs，You can apply for a separate review and approval。
Article 44 Chemical APIP、Accessories and Packaging materials and container association reviews or container associated reviews or individual review and approval，Drug Review Center is at chemical raw materials、Accessories and container and container registration platform for renewal status logo，Public information to the society。Where，Chemicals and drugs are issued to chemical raw materials approved notice and approved production technology、Quality Standards and Tags，The registration number is stated in the approved notice of chemicals and drugs; if it is not approved，Sending a notice of approval for chemical raw materials。
Failure to pass the affiliate review approval，Chemical APIP、The registered status of packaging materials and container products that are directly exposed to medicines and container products remain unchanged，Related drug preparation applications will not be approved。
Section 4 Drug Registration Check
Article 45 Drug registration verification，refers to the authenticity of verifying the application information、Consistency and the commercial production conditions of drug listed，Check the compliance of the development of drugs、Data reliability, etc.，Checking activities carried out on the development site and production site，and the chemical raw materials stake betting appstake sports betting appinvolved in the application of drug registration when necessary、Accessories and container production enterprises that are directly exposed to drugs、Extension inspection activity carried out by suppliers or other trusted agencies。
Principles of Pharmaceutical Registration Checkup、Program、time limit and requirements，The principle of implementing the implementation of the drug registration and verification of the drug registration、Program、time limit and requirements，Established by the Drug Check Center。
Article 46 Drug Review Center according to the degree of drug innovation、Drug research institutions have accepted verification status, etc.，Based on the risk decision whether to carry out the drug registration development site verification。
Drug Review Center decided to launch a drug registration development site verification，Notification Drug Check Center Organize the implementation of verification during the review，Inform the applicant at the same time。Drug Check Center shall complete the on -site inspection within the prescribed time limit，and will check the situation、Check the conclusion and other related materials feedback Drug Review Center for comprehensive review。
Article 47 Drug Review Center according to the specified variety of registration、Craft、Facilities、Earlier checks and other factors，Based on risk decisions whether to start the drug registration production site to verify。
For innovative medicine、Improved new drugs and biological products，Drug registration production site inspections and check -up quality management specifications before listing。
For generic drugs, etc.，According to whether the drug production license has been obtained, there is a listing of the same dosage variety，Perform the drug registration production site for check -in for risk、Checking of drug production quality management specifications before listing。
Article 48 After the application of drug registration is accepted，Drug review center shall conduct preliminary review within 40 days after acceptance，Check the drug registration production site，Notification of the Drug Check Center Organization for verification，Provide the relevant materials required for verification，At the same time, inform the applicant and the province of the applicant or the place where the manufacturer is located、Autonomous Region、Drug supervision and management department of municipality directly under the Central Government。Drug Check Center In principle, the verification work should be completed before 40 days of the review time limit，and will check the situation、Check the results of the results of the verification results to the Drug Review Center。
It is necessary to check the quality management specifications of drug production before listing，Coordinating related provinces by the Drug Check Center、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government and the pharmaceutical registration production site inspection and the implementation of simultaneous implementation。Management requirements for checking the quality management of drug production before listing，Implement in accordance with the relevant provisions of the drug production supervision and management measures。
The applicant shall be verified within the prescribed time limit.
Article 49 Drug Review Center is during the review process，Discover the authenticity of the reporting information or have clear clue reports, etc.，Need to check on the spot and verify，It should be launched with cause inspection，A sampling test if necessary。
Article 50 When applying for a drug listing permit，Applicants and manufacturers should obtain the corresponding drug production license。
Section 5 Drug Registration Inspection
Article 51 Drug registration test，Including standard review and sample inspection。Standard review，refers to the scientific nature of the project setting in the application of the applicant's application for the application of the drug standard、The feasibility of the test method、Reasonable laboratory assessment of quality control indicators。Sample inspection，refers to the laboratory inspection of the sample in accordance with the drug quality standard approved by the applicant or the drug review center。
Principles of Pharmaceutical Registration Inspection、Program、Time limit and other requirements，It is formulated and announced by the Drug Review Center。Pharmaceutical registration application Specific working procedures and requirements for pharmaceutical registration inspection, as well as the technical requirements and specifications of drug registration inspection，It was announced by the Chinese Inspection Institute。
Article 52 The inspection items used in the same variety of drugs collected with national drug standards are consistent with the consistency，You can not review the standard，Only sample test。Other circumstances shall perform standard review and sample inspection。
Article 53 Chinese Inspection Institute or the drug inspection institution designated by the State Drug Administration undertakes the following drug registration inspection:
(1) Innovative drugs;
(2) Improved new drugs (except Chinese medicine);
(3) Biological products、radioactive drugs and in vitro diagnostic reagents according to drugs;
(4) Other drugs stipulated by the State Drug Administration。
Pharmaceutical registration test for overseas produced drugs is implemented by the Chinese Inspection Institute's Organization Port Drug Inspection Institution。
Registration test of other medicines，It is undertaken by the provincial pharmaceutical inspection agency where the applicant or the manufacturer is located。
Article 54 The applicant completes pharmaceutical related research supporting drug listing，Determine the quality standard，and complete the verification of the business scale production process，It can、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government proposes a drug registration inspection;，Starting the drug registration test by the Drug Review Center within 40 days after the application of the drug registration。In principle, the applicant can only propose a pharmaceutical registration test before the drug registration application is accepted，Do not propose a drug registration test to multiple pharmaceutical inspection institutions at the same time。
Drug registration inspection information submitted by the applicant shall be consistent with the corresponding content of the drug registration and declaration，Do not change the pharmaceutical inspection agency during the drug registration inspection process、Sample and information, etc.。
Article 55 Registration application for domestic production drugs，The applicant proposes the drug registration test before the drug registration application is accepted，To related provinces、Autonomous Region、Application for samples for the drug supervision and management department of municipality directly under the Central Government，Provincial、Autonomous Region、The Drug Supervision and Administration Department of the Municipal Government organizes sampling and sealing，The applicant will sample form、Sample、The required materials and standard substances for inspection are sent to the corresponding drug inspection agency。
Registration application for overseas production drugs，The applicant proposes the drug registration test before the drug registration application is accepted，The applicant shall draw samples in accordance with the requirements，Sample、The information required for the inspection and standard substances are sent to the Chinese Inspection Institute。
Article 56 Registration application for domestic production drugs，Drug registration application requires drug registration inspection，Drug Review Center shall issue a drug registration inspection notice to the drug inspection agency and applicant within 40 days after the acceptance。Applicants to related provinces、Autonomous Region、Application for samples for the drug supervision and management department of municipality directly under the Central Government，Provincial、Autonomous Region、The Drug Supervision and Administration Department of the Municipal Government organizes sampling and sealing，The applicant shall sample forms within the prescribed time limit、Sample、The required materials and standard substances for inspection are sent to the corresponding drug inspection agency。
Registration application for overseas production drugs，Drug registration application requires drug registration inspection，The applicant shall draw samples in accordance with the requirements，Sample、The information required for the inspection and standard substances are sent to the Chinese Inspection Institute。
Article 57 Drug inspection agencies shall review the inspection samples and materials submitted by the applicant within five days，Make a decision whether to receive，Inform the Drug Review Center at the same time。It needs to be corrected，Should inform the applicant at one time。
Drug inspection agencies should principle should be at 40 days before the review time limit，Feedback the standard review opinions and inspection reports to the drug review center。
Article 58 In the drug review、During the inspection process，Discover the authenticity of the reporting information or have clear clue reports，Or do you think it is necessary to perform sample inspection，Draw samples for sample inspection。
During the review process，Drug Review Center can propose a single item review of quality standards based on risk。
Chapter 4 Drugs are accelerating the listing registration procedures
Section 1 Breakthrough treatment drug procedures
Article 59 During the clinical trial of the drug，Diseases used to prevent serious life or seriously affect the quality of survival，There is no effective way to prevent or control or have enough evidence compared to existing treatment methods to indicate that innovative drugs or improved new drugs with obvious clinical advantages，Applicants can apply for applicable breakthrough therapeutic drug procedures。
Article 60 Application for applicable to breakthrough therapeutic drug programs，The applicant shall apply to the Drug Review Center。Eligible，Drug Review Center will be included in the breakthrough treatment drug procedure after the procedures are publicized。
Article 61 Pharmaceutical clinical trials of drugs incorporated into breakthrough therapy drugs，Give the following policy support:
(1) Applicants can submit a communication application to the Drug Review Center at the critical stage of the drug clinical trial，The Drug Review Center arranges reviewers to communicate and communicate;
(2) The applicant can submit phased research data to the drug review center，Drug Review Center Based on existing research materials，Make opinions or suggestions on the next research plan，and feedback to the applicant。
Article 62 Pharmaceutical clinical trials of drugs incorporated into breakthrough therapy drugs，The applicant finds that it is no longer in line with the condition of the income，It should be proposed to the drug review center in a timely manner to terminate breakthrough treatment drug procedures。Drug Review Center found that no longer meets the condition of the condition，The breakthrough treatment drug procedure of this variety should be terminated in time，and inform the applicant。
Section 2 Conditional approval procedures
Article 63 During the clinical trial of the drug，Drugs that meet the following circumstances，You can apply for attachment approval:
(1) Drugs that are seriously endangered and have no effective treatment of diseases，Drug clinical trial existing data to confirm the efficacy and predict its clinical value;
(2) Pharmaceuticals urgently needed for public health，Drug clinical trial existing data shows the efficacy and predict its clinical value;
(3) Responsible vaccines in response to major emergencies or other vaccines that are urgently needed by stake online sports bettingstake sports betting appthe National Health and Health Commission，Evaluation benefits are greater than risks。
Article 64 Application of attached conditional approval，The applicant shall communicate with the conditions of the listing and the research work that continue to be completed after the listing.，After confirmation of communication and communication, submit a drug listing license application。
After review，Eliminating the requirements for the approval of the attachment，The validity period of the pharmaceutical registration certificate is stated in the pharmaceutical registration certificate、Research work and completion time limit that needs to be completed after listing。
Article 65 During the review process，Drug registration applications that are found to be included in the attached conditional approval procedure cannot meet the conditional approval conditions，Drug Review Center shall terminate the qualified approval procedure of this variety，and inform the applicant to study and declare in accordance with normal procedures。
Article 66 Pharmaceuticals approved for conditional，The holder shall take the corresponding risk management measures after the drug is listed，and related studies such as clinical trials of drugs within the specified period of time，Application by supplementary application。
For further research requirements for the application for the registration of the vaccine，Vaccine holders shall complete research within the specified period。
Article 67 Pharmaceuticals approved for conditional，The holder fails to complete the study in accordance with the requirements or it cannot prove that its benefit is greater than the risk，The State Drug Administration shall handle it in accordance with the law，until the cancellation of the drug registration certificate。
Section 3 Priority review approval procedures
Article 68 Drug List License Application，The following medicines with obvious clinical value，You can apply for a applicable priority review approval procedure:
(1) Short -required drugs that are urgently needed in clinical urgent need、Innovative drugs and improved new drugs of diseases such as major infectious diseases and rare diseases;
(2) New varieties of children's medicines that conform to children's physiological characteristics、dosage and specifications;
(3) Disease prevention、Control urgent vaccine and innovative vaccine;
(4) Drugs incorporated into breakthrough therapy drug procedures;
(V) Drugs that meet the attached conditions;
(6) The State Drug Administration stipulates the situation of other priority review and approval。
Article 69 Applicants before submitting a pharmaceutical listing license application，It should be communicated with the drug review center，After confirmation of communication and communication，While submitting a drug listing license application，Application for priority review approval to the Drug Review Center。Eligible，Drug Review Center will be included in the priority review approval procedure after the procedures are publicized。
Article 70 Application for the drug listing license for priority review approval procedures，Give the following policy support:
(1) The review time limit for the application for drug listing permit is 130 days;
(II) Rare disease medicines that have not been listed abroad that are urgently needed abroad，The time limit for review is 70 days;
(3) You need to verify、Inspection and approved the common name of the drug，Give priority arrangement;
(4) After confirmation by communication，You can add technical information。
71st item During the review process，Drug registration applications incorporated into the priority review approval procedure cannot meet the conditions for priority review and approval，Drug Review Center shall terminate the priority review approval procedure of this variety，A review by the normal review procedure，and inform the applicant。
Section 4 Special approval procedure
Article 72 When the threat of public health incidents occurs, and after the emergency public health incident,，The State Drug Administration can decide special approval of drugs for preventing and control of emergencies for emergencies in public health incidents。
Article 73 Application for drug registration for special approval，The State Drug Administration is in accordance with unified command、Early intervention、Fast and efficient、Principles of scientific approval，Organization to speed up and simultaneously carry out drug registration acceptance、Review、Check、Test work。Special approval situation、Program、time limit、Requirements, etc. In accordance with the specifications of special approval procedures for the drug。
Article 74 Pharmaceuticals Stake Sports Bettingstake online sports bettingincorporated into special approval procedures，It can be according to the specific needs of disease prevention and control，Limited to use it within a certain period and range。
Article 75 Pharmaceuticals Stake Sports Bettingstake online sports bettingincorporated into special approval procedures，It is found that it no longer meets the conditions of the income，The special approval procedure of the drug should be terminated，and inform the applicant。
Chapter 5 Change and re -register after the drug is listed
Section 1 Research and change after the drug is listed
Article 76 The holder should take the initiative to carry out the drug listing and study，Safety of drugs、Effectivity and quality controller further confirm，Strengthen the continuous management of listed medicines。
Drug registration certificate and attachment requirements The holder to carry out related research work after the drug is listed，The holder shall complete it within the prescribed time limit and submit a supplementary application in accordance with the requirements、File or report。
After the drug is approved to be listed，The holder should continue to carry out drug safety and effective research，Readial application for replenishment in accordance with relevant data or submitting a revision instructions，Continuously update and improve the instructions and labels。The drug supervision and management department can monitor the results of the evaluation results after the drug adverse reaction and the drug listing.，Requires the holder to revise the manual and label。
Article 77 Change after the drug is listed，According to its safety of drugs、The risk of effectiveness and quality controllability and the degree of influence，Classified management，Divided into approval category changes、Recognition Class Change and Report Class Change。
The holder shall be in accordance with relevant regulations，Refer to the relevant technical guidance principles，Comprehensive evaluation、Verify changes for drug safety、Effects of effectiveness and quality controllability，Perform the corresponding research work。
Technical guidance principles for changing research after drug listing，Formulated by the Drug Review Center，announcement to the society。
Article 70 Change below，The holder shall declare it in a supplementary application method，Implementation after approval:
(1) Major changes in the production process of drugs;
(2) The change of effective content involved in the pharmaceutical manual and other content that increases safety risks;
(3) The holder transfers the drug listing permit;
(4) The State Drug Administration stipulates other changes that need to be approved。
Article 79 Change below，The holder shall be before the implementation of the change，The local province is located、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government will record:
(1) Middle changes in the production process of drugs;
(2) Change of the content of the drug packaging label;
(3) Packaging Packaging;
(4) The State Drug Administration stipulates other changes that need to be recorded。
Overseas production drugs have changed above，It should be reported to the Drug Review Center for the Reporting Pharmaceutical Review Center for the change。
Procedures and requirements for the subcontracting filing filing，Established by the Drug Review Center。
Article 80 The following changes should be reported in the annual report:
(1) Small changes in the production process of drugs;
(2) Other changes to the State Drug Administration stipulated that the required reports need to be reported。
Article 81 Supplementary applications proposed after the drug listing，You need to check、Test，Refer to the relevant drug registration verification in these Measures、Inspection procedures for。
Section 2 Re -registration of the medicine
Article 82 The holder shall apply for the six months before the validity period of the drug registration certificate.。Domestic production drugs re -registered applications from the holder to the place where it is located、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government proposed，Overseas production drugs are registered to apply to the holder to the Drug Review Center。
Article 83 After the drug re -registered application for acceptance，Provincial、Autonomous Region、The drug supervision and management department of the municipality or the drug review center directly under the Central Government or the drug review center will be evaluated after the holder is listed and the adverse reaction monitoring.，The relevant work situation is carried out in accordance with the requirements of the drug approval document and the requirements of the drug supervision and management department，and the document of the approval of the drug to review the information changes, etc.，Meeting the requirements，Register for it，Send a notice for re -registration for medicine。Not in line with the requirements，Not registered again，Submit to the State Drug Administration to cancel the drug registration certificate。
Article 84 If there is one of the following circumstances, no registration will be registered:
(1) If the validity period does not submit a re -registration application;
(2) The holder of the pharmaceutical registration certificate cannot perform the quality of the drug、The responsibility of efficacy and adverse reactions;
(3) The research work required by the pharmaceutical approval document and the requirements of the drug supervision and management department cannot be completed within the prescribed time limit;
(4) Evaluation after listing，It is an inaccurate efficacy、Bad reactions or harm to human health due to other reasons;
(5) Law、Others stipulated in administrative regulations will not register again。
Pharmaceuticals that are not registered，Drug registration certificate is valid when the validity period expires。
Chapter 6 Acceptance, withdrawal application, approval decision and dispute resolution
Article 85 The drug supervision and management department will conduct formal review after receiving the application of drug registration，and make a decision based on the following situations:
(1) Application matters do not need to obtain administrative license，It should make decisions that are not accepted immediately，Explain the reason。
(2) The application is not belonging to the scope of the authority of the headquarters，It should make decisions that are not accepted immediately，and inform the applicant to apply to the relevant administrative agency。
(3) There are errors that can be corrected on the spot，The applicant should be allowed to correct on the spot; the application materials are complete after correction、Following the legal form，It should be accepted。
(4) The application information is incomplete or not in line with the legal form，Should be informed of all the contents that the applicant needs correction within five days。According to the regulations, the application materials need to be returned when the notification needs to be notified.，It should be returned。The applicant shall complete the correction information within 30 days。The applicant will not make corrections without any reasons for no proper reasons，It is deemed to have given up application，No decision to make no acceptance。The applicant is not informed of the applicant's correction，Since the date of receiving the application materials, it will be accepted。
(5) The application items belong to the scope of the authority of the headquarters，Reporting information is complete、Follow the legal form，or the applicant submits all correction information as required，Drug registration application should be accepted。
After the application of drug registration is accepted，The applicant needs to pay the fee，The applicant shall pay the fee in accordance with regulations。The applicant does not pay the fee within the prescribed period，Termid drug registration review approval。
Article 87 After the application of drug registration is accepted，New discovery of new drug safety，The applicant shall report it in time and supplement the relevant information。
Article 87 After the application of drug registration is accepted，The applicant needs to supplement the new technical information on the basis of the original application information，Drug review center proposes a supplementary information requirements，After listing all the problems，Notify the applicant in writing to supplement the submission of information within 80 days。The applicant shall submit all supplementary information as required at one time，Supplementary data time is not included in the time limit of drug review。The Drug Review Center received all the applicant's supplementary information and started the review，The time limit for review is extended by one -third; the application for priority review approval procedures，The review time limit is extended one -fourth。
No applicant supplement new technical information，Only the applicant needs to explain the original declaration information，Drug Review Center notification The applicant will submit the relevant explanation instructions in accordance with the requirements within five days。
Drug Review Center believes that there is a substantial defect that cannot be corrected，No longer required applicants to supplement information。Based on the decision to make no approval based on existing application materials。
Article 88 Drug Clinical Test Application、Supplementary applications during clinical trials of drugs，During the review period，Do not supplement new technical information; if you need to carry out new research，The applicant can submit the application after the withdrawal。
Article 89 After the application of drug registration is accepted，The applicant can submit an withdrawal application。Agree with the withdrawal of the application，Drug Review Center or province、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government terminates its registration procedure，and inform the drug registration for verification、Inspection and other technical institutions。Review、During the inspection and inspection, it was found that suspected concealment of the real situation or provided illegal acts such as illegal information，Handling according to law，Applicants must not withdraw from drug registration。
Article 90 During the registration period of the drug，If the conclusion of review is not passed，Drug Review Center shall notify the applicant's reason to not pass，Applicants can raise objections to the Drug Review Center within 15 days。The Drug Review Center combined with the applicant's objections to conduct a comprehensive assessment and feedback the applicant。
The applicant still has objection to the results of the comprehensive evaluation，Drug review center shall be in accordance with regulations，Organize the Expert Consultation Committee to demonstrate within 50 days，and comprehensive expert demonstration results form the final review conclusion。
Applicants' objection and expert demonstration time will not be included in the review time limit。
Article 91 During the registration period of the drug，The applicant believes that the staff is accepted by the drug registration、Review、Check、Test、Approval and other tasks that violate regulations or have irregular behaviors，You can complain to his unit or higher -level organs。
Article 92 Drug registration application meets legal requirements, and it shall be approved.
Drug registration application has one of the following situations，No approval:
(1) Research materials for clinical trial applications for drugs are not enough to support the development of drug clinical trials or cannot guarantee the safety of the subject;
(2) The application information shows that its application for drug safety、Effective、Quality controllability, etc. There are great defects;
(3) The application information cannot prove drug safety、Effective、Quality controllability，or the risk of drugs is greater than benefit after evaluation;
(4) The applicant failed to supplement the information within the prescribed time limit;
(5) The applicant refuses to accept or has no reasons without receiving drug registration verification within the prescribed time limit、Test;
(6) During the registration process of the drug, it is believed that the application information is not true，The applicant cannot prove its authenticity;
(7) Drug registration site verification or sample test results do not meet the regulations;
(8) Other situations that should not be approved by laws and regulations。
Article 93 After the application for application for registration is over，The applicant has objections to the administrative license decision，You can raise administrative reconsideration or administrative litigation。
Chapter 7 Working time limit
Article 94 The time limit stipulated in these Measures is the acceptance of drug registration、Review、Check、Test、The longest time for approval。Preferred review approval procedure related working time limit，Implement the relevant provisions of the review and approval of priority review。
Drug Review Center and other professional and technical institutions shall clarify the work procedures and time limit of the unit，announcement to the society。
Article 95 The drug supervision and management department will conduct formal review after receiving the application of drug registration，It should be accepted within five days、Correction or no acceptance decision。
Article 96 Drug registration review time limit, execute in accordance with the following regulations:
(1) Drug clinical trial application、During the clinical trial period, the review and approval time of the application for application is 60 days;
(2) The time limit for the application for the application of drug listing permit is 200 days，Among them, the review time limit for priority review approval procedures is 130 days，Clinical urgent need for the review time limit for priority review and approval procedures for rare medical drugs overseas is 70 days;
(3) The review time limit for the review of chemical raw materials that have been listed in imitation in the country is 200 days;
(4) Supplementary application review time limit for the change of approval category is 60 days，Supplementary application for merging declaration items，The time limit for review is 80 days，Among them, the data review of clinical trial research、The review time limit for the examination and inspection of drug registration is 200 days;
(5) The approval limit of the common name of the medicine is 30 days;
(6) The appropriate review time limit for non -prescription drugs is 30 days。
The time limit for the association review is consistent with the review time limit for its associated drug preparations。
Article 97 Drug registration verification time limit, execute in accordance with the following regulations:
(1) Drug review center shall notify the drug inspection center within 40 days after the application of the drug registration application，and notify the applicant at the same time;
(2) In principle, the drug verification center completes the drug registration production site verification in the review time limit，and will check the situation、Check the results of the results of the verification results to the Drug Review Center。
Article 98 Pharmaceutical registration test time limit, execute in accordance with the following regulations:
(1) The time limit for the sample test is 60 days，Sample inspection and standard review at the same time is 90 days;
(2) The time limit for supplementary data during the drug registration inspection process is 30 days;
(3) In principle, the pharmaceutical inspection agency completes the work of drug registration inspection before 40 days before the review time limit，and feedback the drug standard review opinions and inspection reports to the drug review center。
Article 99 The time limit for the re -registration review and approval of the drug is 120 days.
1 Hundred Article Administrative approval decision should be made within 20 days.
1001 items The drug supervision and management department shall be issued within ten days from the date of making the drug registration approval decision、Delivery related administrative license documents。
Article 102 Due to the characteristics of the variety and review、Check、Inspection and other tasks, it is necessary to extend the time limit for special circumstances.，The extended time limit must not exceed one -half of the original time limit，Pharmaceutical review、Check、Inspection and other related technical institutions after approval，Written by the technical institution with a extended time limit，and notify other related technical institutions。
Article 103 The following time is not included in the relevant working time limit:
(1) Applicants supplement information、After the stake betting appverification, rectification and check the production process as required、Quality Standards and Manuals occupied;
(2) Delayed verification due to the applicant's reasons、Test、Time to hold an expert consultation meeting, etc.;
(3) The examination and approval procedure of the review and approval of the review and approval of the review and approval procedure is suspended，Time to stop the review and approval procedures;
(4) Start the overseas inspection，Overseas inspection time。
Chapter 8 Supervision and Management
Article 104 The State Drug Administration is responsible for related professional and technical institutions such as the Drug Review Center and other provinces、Autonomous Region、Supervision and Management of the Drug Supervision and Administration Department of the Municipality directly under the Central Government、Assessment Evaluation and Guidance。
Article 105 The drug supervision and management department shall be in accordance with the law、Regulations on the regulations supervise and inspect the drug development activities，If necessary, an extension check for units and individuals providing products or services for drug development，Relevant units and individuals shall cooperate，Do not refuse and conceal。
Article 106 Information Center is responsible for establishing a drug variety file，Code management of medicines，Gathering drug registration and declaration、Safety Reports during clinical trials、Review、Check、Test、Approval and approval after the pharmaceutical listing、filing、Report and other information，and continue to update。Drug variety files and coding management related systems，Established by the Information Center。
Article 107 Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall organize the research institution of non -clinical safety evaluation of drugs in the area under its jurisdiction、Drug clinical trial institutions, etc., abide by the quality management specifications of the non -clinical research quality of drugs、Daily supervision and inspection，Supervise its continuous meetings of legal requirements。The State Drug Administration conducts drug non -clinical safety evaluation research institutions as required、Supervision and inspection by research institutions such as drug clinical trial institutions。
Article 108 The State Drug Administration establishes a drug safety credit management system，Drug Check Center is responsible for establishing a drug non -clinical safety evaluation research institution、Drug Clinical Test Institution Drug Safety Credit Files，Record license issuance、Results of daily supervision and inspection、Investigation and punishment of illegal behavior，announcement to the society in accordance with the law and update it in time。Drug Supervision and Administration Department for bad credit records，Increase the frequency of supervision and inspection，And can implement joint punishment in accordance with national regulations。Drug non -clinical safety evaluation research institutions、Drug Clinical Test Institutional Drug Safety Credit Archives Related System，Established by the Drug Check Center。
Article 109 The State Drug Administration announced the list of drug registration approval and legal basis to the society in accordance with the law、Approval requirements and time limit，Public drug registration progress to the applicant，Publicly approve the conclusion and basis for the review of listed drugs, as well as illegal behaviors found in supervision and inspection，Accept social supervision。
The instructions for the approval of listed drugs should be disclosed and updated in time to the society。Where，The vaccine should also publicly label the content and update it in time。
Without the consent of the applicant，Drug Supervision and Management Department、Professional and technical institutions and their staff、Participants participating in the review of experts shall not disclose the business secrets submitted by the applicant、Unveiled information or confidential business information，The law has other regulations or involved in national security、Except for the public interest of major social society。
Article 100 One of the following circumstances，Logged out the drug registration certificate by the State Drug Administration，and announced:
(1) The holder shall propose the cancellation of the pharmaceutical registration certificate;
(2) No re -registration in accordance with the provisions of these Measures;
(3) Holding people's pharmaceutical registration certificate、Drug production license and other administrative licenses are revoked or revoked according to law;
(4) According to Article 83 of the Drug Management Law，Inaccurate efficacy、Bad reactions or harm to human health due to other reasons;
(5) According to Article 61 of the Vaccine Management Law，Evaluation after listing，Preventive vaccination is serious or other reasons to harm human health;
(6) According to Article 62 of the Vaccine Management Law，After listing, it is evaluated and found that the product design of the vaccine variety、Production process、Safety、Effectability or quality controllability is obviously inferior to prevention、Control other vaccines of the same disease;
(7) Violation of the law、Administrative Regulations Regulations，Failure to complete the corresponding research work within the prescribed time limit in accordance with the requirements of the drug approval document requirements or the requirements of the drug supervision and management department;
(8) Other situations that should cancel the drug registration certificate according to law。
Chapter 9 Legal liability
Article 131 During the registration process of drugs，Provide false certificates、Data、Information、Sample or other means to deceive clinical trial licenses or drug registration permit，According to Article 123 of the Drug Management Law。
Article 112 Application for the clinical trial of vaccine、Register to provide false data、Information、Sample or other deceptions，Processing in accordance with Article 81 of the Vaccine Management Law。
Article 133 During the registration process of drugs，Drug non -clinical safety evaluation research institutions、Drug clinical trial institutions, etc.，Failure to comply with the quality management specifications of the non -clinical research quality of drugs、Drug Clinical Test Quality Management Specifications，According to Article 126 of the Drug Management Law。
Article 114 For the clinical trials of drugs without approval,，It is treated in accordance with Article 125 of the Drug Management Law; if the biological equivalent test is not recorded，Create according to Article 127 of the Drug Management Law。
Article 1005 During the clinical trial of the drug，Discover safety issues or other risks，Clinical trial applicants have not adjusted the clinical trial plan in time、Passing or termination of clinical trials，or not reported to the State Drug Administration，Create according to Article 127 of the Drug Management Law。
Article 1006 Violation of these Measures Article 28、Article 33 stipulates，The applicant has one of the following situations，Order to make corrections within a time limit;，Fined fines of 10,000 yuan and less than 30,000 yuan:
(1) Registration was not performed on the clinical trial registration and information publicity platform before conducting clinical trials of drugs;
(2) The safety update report was not submitted during the R & D period in accordance with regulations;
(3) Information and other information of the clinical trial after the clinical trials of the drug。
Article 137 Drug inspection agencies when they bear the inspection work required for drug registration，issue a false inspection report，Create according to Article 138 of the Drug Management Law。
Article 138 Approve the clinical trial of drugs for not meeting the conditions、Drugs that are not eligible to issue a drug registration certificate，According to Article 147 of the Drug Management Law。
Article 119 The drug supervision and management department and its staff have illegal and illegal acts in the process of drug registration，Handling in accordance with relevant laws and regulations。
Chapter 10 Attachment
Article 120 Anesthesiologist、Psychiatric drugs、Medical toxic drugs、Radial drugs、Pharmaceutical Easy toxic chemicals, etc., have other special management registered applications for drugs，Except in accordance with the provisions of these Measures，It should also meet other relevant regulations of the country。
Article 121 The standard for export vaccines shall meet the standards or contract requirements of importing countries (regions)。
Article 122 Pharmaceuticals to be registered for registration，Already defined by similar products with attributes，declared according to the medicine;，The applicant shall apply to the National Drug Administration for product attribute definition to the State Drug Administration。The attribute is defined as a drug -based，Register according to the procedures specified in these Measures，Among them, the research materials that belong to the medical device are partly conclusions by the National Drug Administration's Medical Device Technology Review Center，Transfer to Drug Review Center for comprehensive review。
Article 123 Approval number format for domestic production drugs is: Chinese medicine accurate word H (z、s) + Four years + four -bit sequence number。Hong Kong, China、The format of the production number of the production drug in Macau and Taiwan is: the national medicine accurate word H (z、s) C + Four -digit annual number + four -bit sequence number。
Approval number format for overseas production drugs is: Chinese medicine accurate word H (z、s) J + Four -digit annual number + four -bit sequence number。
Where，H represents chemical medicine，Z represents Chinese medicine，s represents biological products。
Pharmaceutical approval number，Don’t change due to changes in registration after listing。
Chinese medicine has other regulations.
Article 124 Pharmaceutical registration approval proof of drug registration approved electronic files and raw materials approved files and paper files produced by the drug supervision and management department have the same legal effect as paper files。
Article 125 The deadline stipulated in these Measures is calculated by working days.
Article 126 This method will be implemented from July 1, 2020。On July 10, 2007, the "Measures for Registration Management Measures for Drug Registration" announced by the former State Food and Drug Administration on July 10th。
