Chapter 1

Article 1 is to ensure the safety of the drug、Effectiveness and quality controlled，Standardized drug registration behavior，According to the "Drug Management Law of the People's Republic of China" (hereinafter referred to as the "Drug Management Law")、"Administrative License Law of the People's Republic of China" (hereinafter referred to as the "Administrative License Law")、"Regulations on the Implementation of the Drug Administration Law of the People's Republic of China" (hereinafter referred to as the "Implementation Regulations of the Drug Management Law")，Formation of this method 。

Article 2 Apply for clinical trials for drugs in the People's Republic of China、Drug production and drug imports，and drug approval、Registration inspection and supervision and management，Applicable these Measures。

Article 3 Drug Registration，refers to the application of the State Food and Drug Administration based，According to legal procedures，Safety of selling drugs to be listed、Effective、Quality controllability, etc.，and decide whether to agree to the approval process of its application。

4 The state encourages research and creation of new medicines，New medicine for created、New drugs for the treatment of difficult and critical diseases are implemented for special approval。

5 The State Food and Drug Administration is in charge of national drug registration，Responsible for clinical trials of drugs、Approval of drug production and imports。

Article 6 Drug registration shall follow the public、Fairness、Principles of Justice。

The State Food and Drug Administration implemented a collective responsibility system for drug registration、Relevant personnel publicity and avoidance system、Responsibility System，Acceptance、Test、Review、Approval、Delivery and other links accept social supervision。

Article 7 During the registration of the medicine，Drug Supervision and Administration Department believes that major permits involving public interests，It should be announced to the society，Hold a hearing。

Administrative license directly involves the major interest relationship between applicants and others，The drug supervision and management department is making an administrative license decision，shall inform the applicant、Persons with interested parties enjoy a required hearing、The right to state and defense。

Article 8 The drug supervision and management department shall provide the applicant with the pharmaceutical registration acceptance of the inquiry、Check、Test、Review、The progress of the approval and conclusion。

The drug supervision and management department shall disclose the following information on the website of the administrative organs or register an application for acceptance::

(1) stake sports betting appDrug registration application items、Program、Toll standards and basis、time limit，All the material directory and application text of the application required for submission;

(2) Drug registration acceptance、Check、Test、Review、Approval list and relevant information;

(3) Comprehensive information such as the approved drug directory.

9th drug supervision and management department、Related units and personnel participating in drug registration，Technical secrets submitted by the applicant and the obligation of confidentiality of experimental data。 

Chapter 2

Article 10 Drug Registration applicant (hereinafter referred to as applicants)，refers to an institution that submits a stake sports betting appDrug registration application and undertakes the corresponding legal liability。

The domestic applicant shall be an institution that legally registered in China and can independently assume civil liability，Overseas applicants should be overseas legal pharmaceutical manufacturers。Overseas applicants handle imported drug registration，It should be handled by its offices in China or the Chinese agency entrusted by it。

Personnel who handle stake sports betting appDrug registration applications shall have corresponding professional knowledge，Familiar with the law of drug registration、Regulations and technical requirements。

Article 11 stake sports betting appDrug registration application includes new drug applications、Imitation drug application、Imported drug applications and their supplementary applications and re -registration applications。

Application of drugs in the domestic applicant application according to new drugs、Procedures and requirements for the application of generic drugs，Overseas applicants apply for imported drugs.。

Article 12 New Drug Application，Refers to the registration application for drugs that have not been listed in China。

Change the dosage type for the available drugs、Change the way of administration、Pharmaceutical registration that adds new indications is declared in accordance with the procedure applied for new drugs。

Imitation drug application，refers to the registration application of existing national standard drugs that have been approved by the National Food and Drug Administration for the production of the State Food and Drug Administration;。

Imported drug applications，Refers to the registration application of drugs produced abroad in China。

Supplementary application，refers to the application of new drugs、Application of generic drugs or imported drugs is approved，Change、Add or cancel the registration application for the original approval or content。

Register to apply，refers to the applicant's plan to continue production or import of the drug after the validity period expires。

Article 13 The applicant shall provide full and reliable research data，Prove the safety of the drug、Effectivity and quality controllability，and be responsible for the authenticity of all information。

Article 14 The information reported by the Drug Registration shall indicate the name of the book、Publication name and volume、Issue、page, etc.; The documents that have not been published publicly shall provide the certification file permitted by the data owner。Foreign language information shall provide Chinese translations as required。

Article 15 The State Food and Drug Administration shall implement the development plan and industrial policy formulated by the country's pharmaceutical industry，You can organize the evaluation of the listing value of the medicine。

Article 16 During the registration process of drugs，The drug supervision and management department shall have a non -clinical study、Clinical trials conduct on -site verification、There is a cause of verification，and the production site inspection before the listing，To confirm the authenticity of the declaration information、accuracy and integrity。

Article 17, two or more units as applicants，It should be provided with the place where the pharmaceutical manufacturer is located、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government submits an application; the applicant is all the pharmaceutical manufacturers，The province of the pharmaceutical manufacturer who applies for the production agent should be、Autonomous Region、The pharmaceutical supervision and management department of the municipality directly under the Central Government will apply; the applicant is not a pharmaceutical manufacturer，It should be province where the sample trial production site is located、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government submits an application。

Article 18 The applicant shall apply to the registered drug or prescription for the registered、Technology、Uses, etc.，Provide an explanation of the applicant or others' patents and its ownership in China; others have patents in China，The applicant shall submit a statement that does not constitute an infringement of the patent of others。Explanation or statement submitted by the applicant，The drug supervision and management department shall publicize it on the website of the administrative organs。

Patent disputes occurred during the registration process of drug registration，Following the laws and regulations of relevant patents。

Article 19 Drugs that have obtained Chinese patent rights to others，The applicant can submit a registration application within 2 years before the patent period of the drug patent。The State Food and Drug Administration will review it in accordance with these Measures，Meeting the prescribed，Employment of drug approval number after the patent expires、"Import Drug Registration Certificate" or "Medical Product Registration Certificate"。

Article 20 shall be in accordance with Article 35 of the Implementation Regulations of the Drug Management Law，For producers or sellers who have obtained production or sales of drug licenses containing new chemical ingredients, the test data and other data that has not been disclosed，The National Food and Drug Administration will be within 6 years from the date of approval of the permit，Agree to the applicant who has not been licensed，Applications that use their unveiled data are not approved; but except for applicants submit their own data。

Article 21 Pharmaceutical pre -clinical study for application for drug registration，Including the synthetic process of drugs、Extraction method、Physical and chemical properties and purity、Quality indicator、Testing method、Preparation process、Testing method、Quality indicator、Stability、Pharmacology、Toxicology、Research on Dynamics of Animal Pharmaceuticals。Chinese medicine preparations also include the source of the original medicinal materials、Processing and processing research; biological products also include bacterial poison species、Cell Co., Ltd.、Source of starting raw materials such as biological tissue、Quality Standards、Save conditions、Biological features、Research on genetic stability and research of immunology。

Article 22 The pre -clinical study of drugs shall implement relevant management regulations，Among them, safety evaluation research must implement the "Specifications for Quality Management Quality Management of Drugs"。

Article 23 Drug research institutions shall have personnel who are compatible with test research projects、venue、Equipment、Instrument and management system，and ensure the authenticity of all test data and data;、Reagents and raw materials shall comply with relevant national regulations and requirements。

Article 24 The applicant entrusts other institutions to conduct drug research or conduct a single test、Test、Trial production of samples，Should sign a contract with the entrusted party，and explain when applying for registration。The applicant is responsible for the authenticity of the drug research data in the application information。

Article 25，Research raw materials must have a drug approval number、"Import Drug Registration Certificate" or "Medical Product Registration Certificate"，and must be obtained through legal channels。Research on the raw medicine does not have a drug approval number、"Import Drug Registration Certificate" or "Medical Product Registration Certificate"，It must be approved by the State Food and Drug Administration。

Article 26 The drug test research data provided by the foreign drug research institution，It must be attached to the item provided by the information provided by the overseas drug research institution、Page number Listing description and proof of the certification document of the public notice that the agency has legally registered abroad。The State Food and Drug Administration organizes on -site inspections based on the need for review。

Article 27 The drug supervision and management department may ask the applicant or the drug research institution to undertake the test of the test of the project、Methods and data for repeated tests，You can also entrust the drug inspection institution or other drug research institutions to conduct repeated tests or methodology verification。

Article 28 Drug Studies Refer to the relevant technical guidance principles released by the State Food and Drug Administration，Applicants use other evaluation methods and technologies，The information that proves its scientificity should be submitted。

Article 29 After the applicant gets the drug approval number，The production process production approved by the State Food and Drug Administration should be produced。

Drug Supervision and Administration Department Supervision and Inspection and Inspection of the production situation of the applicant in accordance with the approved production process and quality standards。

Chapter 3

The clinical trials of Article 30 (including biological equivalent tests)，It must be approved by the State Food and Drug Administration，and must be performed "Specifications for the Management of the Quality Management of Drug Clinical Test"。

The drug supervision and management department shall supervise and inspect the approved clinical trials。

Article 31 Apply for new drug registration，Clinical trials should be conducted。Application and supplementary application for generic drugs，Clinical trials in accordance with the provisions of this Measures。

Clinical trials are divided into I, II, III, and IV stage.

I phase I clinical trial: Preliminary clinical pharmacology and human safety evaluation test。Observe the human body's tolerance to the degree of new drugs and pharmacokinetics，Provide a basis for formulating a dosing plan。

Phase II Clinical Test: Preliminary Evaluation Period of therapeutic effect。Its purpose is to preliminary evaluation of the treatment and safety of drugs for patients with target adaptive patients，It also includes providing a basis for the determination of the research design and dose scheme for the study of the phase III clinical trials。The research design at this stage can be based on specific research purposes，Use a variety of forms，Including the clinical trial of the random blind method。

Phase III Clinical Test: The OK stage of the therapeutic effect。The purpose is to further verify the treatment and safety of drugs for patients with target adaptive patients，Evaluation interest and risk relationship，Finally provides a sufficient basis for the review of stake sports betting appDrug registration applications。Tests should generally be a random blind method comparison test with sufficient sample volume。

IV Clinical Test: Research Stage of stake online sports bettingApplication after the listing of new drugs。Its purpose is to examine the efficacy and adverse reactions of drugs under extensive conditions，Evaluation of the interests and risk relationships used in ordinary or special groups, as well as improved doses。

Biological equivalent test，refers to the method of research using biological utilization，Using pharmacokinetic parameters as an indicator，Compared with the same or different dosage formats in the same drug，Under the same test conditions，The degree of absorption and speed of the active ingredients with statistical differences。

Article 32 The number of test cases of clinical trials of drugs shall meet the purpose of clinical trials and relevant statistical requirements，and not less than the number of minimum clinical trial cases specified in the attachment of these Measures。Rare disease、Special diseases, etc.，Requires the number of clinical trial cases or free clinical trials，It should be proposed when applying for clinical trials，and with the review and approval of the State Food and Drug Administration。

Article 33 Vaccine or other special drugs prepared during the selection stage of the bacterial poison species，There is no suitable animal model and the laboratory cannot evaluate its efficacy，Under the premise of ensuring the safety of the subject，Can apply to the State Food and Drug Administration for clinical trials。

Article 34 After approval of the clinical trials of the drug，The applicant shall choose an institution that bears drug clinical trials from institutions with drug clinical trials。

Article 35 of the clinical trial drugs shall be prepared in the workshop that complies with the "Management of Drug Production Quality Management"。The preparation process shall strictly implement the requirements of the "Specifications for the Management of Drug Production Quality"。

The applicant is responsible for the quality of clinical trial drugs.

Article 36 The applicant may self -examine the clinical trial drugs，You can also entrust the Drug Inspection Institute for this Measure to test; vaccine products、Blood Products、Other biological products stipulated by the State Food and Drug Administration，It should be tested by the Drug Inspection Institute designated by the State Food and Drug Administration。

Clinical trials can be used for clinical trials after passing the drug test。

Drug Supervision and Administration Department can test and test on clinical trial drugs。

Article 37 Before the implementation of the drug clinical trial，The name of the determined clinical trial scheme and clinical trial responsible unit should be、Participate in the list of research units and its researchers、Ethics Committee review consent form、Instead of consent, samples, etc. submitted to the State Food and Drug Administration for filing，Copy to the location of the clinical trial unit and the province that accepts the application、Autonomous Region、Drug supervision and management department of municipality directly under the Central Government。

Article 38 The applicant finds that the clinical trial institution of the drug violates the relevant regulations or fails to perform in accordance with the clinical trial plan.，It should be urged to make corrections;，It can be required to suspend or terminate clinical trials，Report the situation to the State Food and Drug Administration and relevant provinces、Autonomous Region、Drug supervision and management department of municipality directly under the Central Government。

Article 39 After the applicant completes clinical trials，The clinical trial summary report shall be submitted to the State Food and Drug Administration、Statistical Analysis Report and Database。

Article 40 Drug clinical trial shall be implemented within 3 years after approval。If the overdue is not implemented，The original approval document was abolished by itself; clinical trials need to be performed，It should be re -apply。

Article 41 The clinical trial process of severe adverse events，Researchers should report about provinces within 24 hours、Autonomous Region、Drug Supervision and Administration Department of Municipality and State Food and Drug Administration，Notification applicant，Report to the Ethics Committee in time。

Article 42 The clinical trials have one of the following circumstances，The National Food and Drug Administration can order the applicant to modify the test plan、Passing or termination clinical trial:

(1) If the Ethics Committee has not fulfilled its duties;

(2) It cannot effectively guarantee the safety of the subject;

(3) If a serious adverse event report is not reported in accordance with the prescribed time limit;

(4) There is evidence to prove that clinical trial drugs are invalid;

(5) The quality problem of drugs for clinical trials;

(6) False in clinical trials;

(7) Other situations that violate the "Specifications for Quality Management of Clinical Test of Drugs"。

Article 43 A large range of clinical trials、Non -expected adverse reactions or serious adverse events，or evidence to prove that there are serious quality problems in clinical trial drugs，National Food and Drug Administration or province、Autonomous Region、The drug supervision and management department of municipality directly under the Central Government can take emergency control measures，Order to suspend or terminate clinical trials，Applicants and clinical trial units must immediately stop clinical trials。

Article 44 The overseas applicant conducts the clinical trials of international multi -center drugs in China，​​It shall apply to the State Food and Drug Administration in accordance with these measures，and handle according to the following requirements:

(1) Drugs for clinical trials should be a drug registered overseas or drugs that have entered the phase II or phase III clinical trials; Application for clinical trials of international multi -central drugs with vaccine drugs;

(2) The State Food and Drug Administration is approved to conduct international multi -center drug clinical trials，It can be required to require applicants to conduct phase I clinical trials in China;

(3) When conducting clinical trials of international multi -center drugs in China，Discover serious adverse reactions and non -expected adverse reactions related to the drug in any country，The applicant shall report the State Food and Drug Administration in a timely manner in accordance with relevant regulations;

(4) After the clinical trial is over，The applicant shall report the complete clinical trial report to the State Food and Drug Administration;

(5) The data obtained by the clinical trials of international multi -center drugs is used for registering for drug registration in China，It should meet all the research materials of these Measures on clinical trials and submit it to the international multi -center clinical trials。

Chapter 4

Article 45 The State Food and Drug Administration can implement special approval for the following applications:

(1) Plants that have not been sold in China、Animals、Effective ingredients and preparations extracted from the minerals and other substances，Newly discovered medicinal materials and their preparations;

(2) Chemicals and preparations that have not been listed at home and abroad、Biological products;

(3) Treatment of AIDS、malignant tumors、New drugs with rare diseases and other diseases and have obvious clinical treatment advantages;

(4) New medicines for diseases that have no effective treatment methods.

Drugs stipulated in the previous paragraph，Applicants can apply for special approval during the drug registration，Organization of the Expert Meeting of the Pharmaceutical Review Center of the State Food and Drug Administration discusses determining whether special approval is implemented。

Specific measures for special approval will be formulated separately.

New drugs jointly developed by multiple units，One of them should apply for registration，Other units must not apply repeatedly;，It should be jointly signed as the applicant of the new drug。Application for new drugs is approved for each variety，including different specifications of the same variety，It can only be produced by one unit。

Article 47 Register for registered applications for changing dosage forms that have been listed on the market，New technologies should be adopted to improve the quality and safety of drugs，and more obvious clinical application advantages compared with the prevalence。

Change the dosage form but does not change the way of administration，and the registration application for adding new indications，It should be proposed by an enterprise with production conditions; a targeted preparation、Slow release、Special dosage types such as controlling preparations except。

Article 48 During the approval of the new drug，The registration classification and technical requirements of the new drug do not change due to the preparation of the same activity ingredients abroad。

During the approval of the new drug，Its registered classification and technical requirements do not change due。

Article 49 Drug registration declaration information shall be submitted at one time，stake sports betting appDrug registration application must not supplement new technical information after acceptance; registration application for special approval procedures or new discoveries involved in drug safety，Except for the information as required。The applicant believes that it must supplement the new technical information，It should withdraw its drug registration application。The applicant re -declared，It should meet the relevant provisions of these Measures without the same variety to enter the new drug monitoring period。

Article 50: The applicant completes the clinical post -clinical research，It should be filled in the "stake sports betting appDrug registration application Form"，province in your place、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government reports the relevant information in truth。

Article 51 province、Autonomous Region、The drug supervision and management department of municipality directly under the Central Government shall review the application materials for form，Meeting the requirements，Failure to issue a notice of acceptance of stake sports betting appDrug registration applications;，Failure to issue a drug registration application will not be accepted，Explain the reason。

Article 52 province、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall organize on -site verification of drug development and original data within 5 days from the date of acceptance of the application，Preliminary review of the application information，Make a review opinion。The medicine applying for registration is a biological product，It is necessary to take 3 inspection samples for production batch numbers，and issue a registered inspection notice to the Drug Inspection Institute。

Article 53 province、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall review the review opinions within the prescribed time limit、Check the report and the application information is sent to the Drug Review Center of the State Food and Drug Administration，and notify the applicant。

Article 54 of the Drug Inspection Institute, which receives a registered inspection notice, should be inspected for samples in accordance with the drug standards declared by the applicant，Review the application for the application of the application for the application，And send the drug registration inspection report to the National Food and Drug Administration for the Drug Review Center within the prescribed time，Copy the applicant。

Article 55 After the Drug Review Center of the State Food and Drug Administration received the application information，Organize pharmacology within the specified time、Medical and other technical personnel conduct technical reviews on the application materials，If necessary, you can ask the applicant to supplement the information，Explain the reason。After completing the technical review，Put forwarding technical review opinions，Put it to the State Food and Drug Administration。

The State Food and Drug Administration makes a decision on approval based on the technical review opinions。Meeting the prescribed，Send it to "Drug Clinical Test Approval"; not in line with the prescribed，Send to the "Notice of Approval Opinions"，Explain the reason。

56 After the applicant completes the clinical trial of the drug，It should be filled in the "stake sports betting appDrug registration application Form"，province in your place、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government submits the application information for application for production，and at the same time, the raw materials and research materials of the preparation of standard products and related standard substances reported to the Chinese pharmaceutical biological products。

Article 57 is the same as Article 51.

Article 58 province、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall organize on -site verification of clinical trials and related original materials within 5 days from the date of acceptance，Preliminary review of the application information，Make a review opinion。Other medicines except biological products，Also need to take 3 samples，Notification of standard review issued to the Drug Inspection Institute。

Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall review the review opinions within the prescribed time limit、Check the report and declare information to the National Food and Drug Administration Drug Review Center，and notify the applicant。

Article 59 Drug Standards reported by the Drug Inspection Institute for review，and send the review opinion to the National Food and Drug Administration Drug Review Center within the prescribed time，Copy to the province that notified its review at the same time、Autonomous Region、Drug supervision and management department and applicant of municipalities directly under the Central Government。

Article 60 After the Drug Review Center of the State Food and Drug Administration received the application information，It should organize pharmacy within the specified time、Medical and other technical personnel review the application information，If necessary, you can ask the applicant to supplement the information，Explain the reason。

The review of the review meets the requirements，The Drug Review Center of the State Food and Drug Administration notified the applicant to apply for production site inspection，and inform the National Food and Drug Administration of Drug Certification Management Center; if the review does not meet the requirements，The Pharmaceutical Review Center of the State Food and Drug Administration will submit review opinions and relevant information to the State Food and Drug Administration，National Food and Drug Administration based on technical review opinions，Make a decision that is not approved，Send to the "Notice of Approval Opinions"，Explain the reason。

Article 61 The applicant shall submit an application for on -site inspections to the Drug Certification Management Center of the State Food and Drug Administration within 6 months from the date of receiving the notice of the production site inspection notice。

Article 62 The Drug Certification Management Center of the State Food and Drug Administration after receiving the application for production site inspection，It shall organize on -site inspections on the batch production process of samples within 30 days，Confirm the feasibility of the approved production process，Take 1 sample (3 batch of samples) at the same time at the same time，Send the Drug Inspection Institute for the Drug Standard Relikers，And the production site inspection report will be sent to the National Food and Drug Administration for the Drug Review Center of the State Food and Drug Administration within 10 days after the completion of the on -site inspection。

Article 63 The sample shall be produced in the workshop that obtains the certification certificate of the Quality Management of Drug Production;、Pharmaceutical manufacturer new drug production workshop or new production dosage type，Its sample production process shall meet the requirements of the "Management of Quality Management of Drug Production"。

Article 64 The Drug Inspection Institute shall test the My stake betting appsamples extracted in accordance with the approved drug standards，Same as 54，Copy for related provinces at the same time、Autonomous Region、Drug supervision and management department and applicant of municipalities directly under the Central Government。

Article 65: The Drug Review Center of the State Food and Drug Administration based on technical review opinions、Sample production site inspection report and sample inspection results，Form comprehensive opinions，Put it to the State Food and Drug Administration。National Food and Drug Administration based on comprehensive opinions，Make an approval decision。Meeting the prescribed，Send to the new drug certificate，The applicant already holds the "Drug Production License" and has production conditions，Send it to the drug approval number at the same time; if it does not meet the requirements，Send to the "Notice of Approval Opinions"，Explain the reason。

Change the dosage form but does not change the way of administration，and the registration application for adding new indications will not be issued after approval;、Slow release、Special dosage types such as controlling preparations except。

Article 66 The State Food and Drug Administration shall be based on the requirements of protecting public health，You can set up a monitoring period for the new drug species approved for production。Calculated from the date of production of new drugs，The longest must not exceed 5 years。

New medicine during the monitoring period，The National Food and Drug Administration does not approve other companies to produce、Change the dosage form and import。

Article 67 Drug production enterprises shall inspect the production process of new drugs during the monitoring period、Quality、Stability、curative effect and adverse reactions, etc.，and province to the local area every year、Autonomous Region、Report on the drug supervision and management department of municipality directly under the Central Government。Drug production enterprises have not fulfilled the monitoring period liability，Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall order it to make corrections。

Article 68 Drug Production、Business、Use and test、Supervision unit found that there are serious quality problems in new drugs、Severe or non -expected adverse reactions，It should be provincial、Autonomous Region、Report on the drug supervision and management department of municipality directly under the Central Government。Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government should organize an investigation immediately after receiving the report，Report the State Food and Drug Administration。

Article 69 Pharmaceutical manufacturers to establish a monitoring period from the date of the monitoring period.，The National Food and Drug Administration can approve the application for the production of the new drug proposed by other pharmaceutical manufacturers，and re -monitor the new drug。

Article 70 from the date of the monitoring period，The State Food and Drug Administration has approved other applicants to conduct drug clinical trials，You can continue to apply for this application in accordance with the stake sports betting appDrug registration application and approval procedures，Meeting the prescribed，The National Food and Drug Administration approves the production or import of the new drug，and monitor the new drug produced by domestic drug manufacturers。

Article 71 of the new drugs from the date of the monitoring period，No longer accepts the same variety registration application of other applicants。Other applicants who have accepted but have not yet approved the clinical trials of drugs will be returned; after the new drug monitoring period expires，The applicant can submit an emotional drug application or imported drug application。

Article 72 Application for Import Drug Registration First gets approved first，The domestic applicant has been approved to conduct clinical trials，You can continue to apply for its application in accordance with the stake sports betting appDrug registration application and approval procedures，Meeting the prescribed，The National Food and Drug Administration approves it to make production; the applicant can also withdraw this application，Re -submit an application for generic drugs。Other applications for clinical trials that have been accepted but not yet approved for drug clinical trials will be returned，Applicants can submit an emulative drug application。 

Chapter 5

Article 73 The applicant of generic drugs shall be a pharmaceutical manufacturer，The medicines they apply should be consistent with the scope of production stated in the "Drug Production License"。

Article 74 of the generic drugs shall have the same active ingredients as the generic drugs、Drug approach、Dosage type、Specifications and the same treatment effect。There are varieties produced by many companies，Should refer to the relevant technical guidance principles to select the generic drug for control research。

Article 75 Application for registration of generic drugs，It should be filled in the "stake sports betting appDrug registration application Form"，province in your place、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government submits relevant information and the application for inspection of production site。

Article 76 province、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government conducts formal review of the application information，Regulations of Article 51。

The protection of traditional Chinese medicine species，From the date of acceptance of the protection of the Chinese medicine variety to make the administrative decision，Speaking of the application of the same variety of generic drug applications。

Article 77 province、Autonomous Region、The drug supervision and management department of municipality directly under the Central Government shall organize on -site verification of the development situation and original materials within 5 days from the date of acceptance of the application，And organize production site inspections based on the production process and quality standards provided by the applicant，3 samples of continuous production on the spot，Pharmaceutical Inspection Institute。

The production of samples shall comply with the provisions of Article 63 of these Measures。

Article 78 province、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall review the application materials within the prescribed time limit，Make a review opinion。Meeting the prescribed，A review opinions、Check Report、Production on -site inspection report and declaration information is sent to the National Food and Drug Administration's Drug Review Center，notify the applicant at the same time;，Send to the "Notice of Approval Opinions"，Explain the reason，At the same time, notify the Drug Inspection Institute to stop the registration of the drug。

Article 79 Drug Inspection Institute should inspect the samples extracted，Standards for Article 54，Copy to the province that notified its test at the same time、Autonomous Region、Drug supervision and management department and applicant of municipalities directly under the Central Government。

Article 80 The Drug Review Center of the State Food and Drug Administration shall organize pharmacy within the prescribed time、Medical and other technical personnel review the review opinions and declaration materials，If necessary, you can ask the applicant to supplement the information，Explain the reason。

Article 81 and Article 65，Form comprehensive opinions，Submit to the State Food and Drug Administration with relevant information，National Food and Drug Administration based on comprehensive opinions，Make an approval decision。Meeting the prescribed，Send to the drug approval number or "Pharmaceutical Clinical Test approval"; if it does not meet the requirements，Send to the "Notice of Approval Opinions"，Explain the reason。

Article 82 After the applicant completes the clinical trial，Should report clinical trial information to the Drug Review Center of the State Food and Drug Administration。National Food and Drug Administration based on technical opinions，Send to the drug approval number or "Notice of Approval Opinions"。

Article 83 The listing drugs that have confirmed safety problems，The State Food and Drug Administration can decide to suspend the acceptance and approval of its generic drug application。 

Chapter 6

Article 84 Drugs applying for imports，It should be obtained by listing permits in the production countries or regions where overseas pharmaceutical manufacturers are located;，But confirmed the drug safety of the State Food and Drug Administration、Effective and clinically required，can be approved to be imported。

Apply for imported medicines，Its production shall meet the requirements of the country or regional drug production quality management specifications and the requirements of China's "Quality Management of Drug Production"。

Article 85 Application for Import Drug Registration，It should be filled in the "stake sports betting appDrug registration application Form"，Submit relevant information and samples，Provide relevant certification documents，Apply to the State Food and Drug Administration。

Article 86 The State Food and Drug Administration conducts formal review of the application information，Meeting the requirements,Feeling a notice of acceptance of drug registration，and notified the Chinese Drug Biological Products Institute for the organization to register for a sample of 3 production batch numbers;,Failure to issue a stake sports betting appDrug registration application will not be accepted，Explain the reason。

The National Food and Drug Administration can organize on -site inspections of its development and production conditions，Sample。

Article 87 After the information and samples received by the Chinese Drug Biological Products Institute，It should be organized within 5 days to conduct a registered inspection。

Article 88 of the Drug Inspection of Imported Drug Registration Inspection Receives the information、Sample and related standard substances，The registered inspection should be completed within 60 days and submitted the pharmaceutical registration inspection report to the Chinese pharmaceutical and biological product testing office。

Sample inspection and drug standard review of special drugs and vaccine products shall be completed within 90 days。

Article 89 After receiving a drug registration inspection report and imported drug standards that have been reviewed by the Chinese Drug Biological Products，It should organize experts to conduct technical review within 20 days，If necessary, you can re -review according to the review opinion。

Article 90 After the import and inspection of the imported drugs of Chinese pharmaceutical biological products，Drug standards for review should be、Drug Registration Inspection Report and Review Opinions are sent to the Drug Review Center of the State Food and Drug Administration，Copy the applicant。

Article 91 The Drug Evaluation Center of the State Food and Drug Administration shall organize pharmacy within the prescribed time、Medical and other technical personnel review the application information，If necessary, you can ask the applicant to supplement the information，Explain the reason。

Article 92 The National Food and Drug Administration's Drug Review Center is based on technical review opinions and sample inspection results，Form comprehensive opinions，Submit to the State Food and Drug Administration with relevant information，Same as Article 81，Send it to "Drug Clinical Test Approval"; not in line with the prescribed，Send to the "Notice of Approval Opinions"，Explain the reason。

Article 93 After the clinical trial was approved，The applicant shall test in accordance with the third chapter of these Measures and the relevant requirements。

After the clinical trial is over，The applicant shall fill in the "stake sports betting appDrug registration application Form"，Submit clinical trial materials and other changes and supplementary materials in accordance with regulations，and explain the basis and reason in detail，Provide relevant certification documents。

Article 94 The Drug Review Center of the State Food and Drug Administration shall organize pharmacy within the prescribed time、Medical and other technical personnel conducts comprehensive reviews on the clinical trials submitted to the report，If necessary, you can ask the applicant to supplement the information，Explain the reason。

Regulations of Article 81。Meeting the prescribed，issued to "Imported Drug Registration Certificate"。Hong Kong, China、Pharmaceutical manufacturers in Macau and Taiwan apply for registered medicines，Refer to the procedure for the application for the registration of imported drugs，Meeting the requirements，issue to the "Medical Product Registration Certificate"; if it does not meet the requirements，Send to the "Notice of Approval Opinions"，Explain the reason。

Article 95 Apply for imported drug preparations，Certificate documents that must be provided with the legal source of the packaging of drugs and containers that are directly exposed to drugs、Certificate documents for the legitimate source of the raw medicine and auxiliary materials used for the production of this preparation。The raw and medicine and auxiliary materials have not been approved by the State Food and Drug Administration，It should be submitted to the relevant production process、Research materials for specifications such as quality indicators and inspection methods。

Article 96 Imported Drug Packaging，refers to the production process of drugs that have completed the final preparations abroad，Changed from large packaging specifications to small packaging specifications，or the medicine that has completed the internal packaging is performed、Place instructions、Paste labels, etc.。

Article 97 Application for imported drugs and packaging，It should meet the following requirements:

(1) The drug has obtained the "Import Drug Registration Certificate" or "Medical Product Registration Certificate";

(2) This drug should be a variety that has not been produced in China，or although there are production, it cannot meet the varieties of clinical needs;

(3) The same variety of the same pharmaceutical manufacturer shall be packaged by a pharmaceutical manufacturer，The term of the sub -packaging must not exceed the validity period of the "Imported Drug Registration Certificate" or "Medical Product Registration Certificate";

(4) Dividection、Capsule outside，Other dosage forms of the sub -packaging should be completed overseas internal packaging;

(5) Pharmaceutical manufacturers receiving sub -packaging，Should hold "Drug Production License"。Imported nude、Capsule applications are sub -packaged in China，Pharmaceutical manufacturers accepting the sub -packaging should also hold the "Quality Management Specification of Drug Production Quality" certification with the dosage form forming of sub -packaging;

(6) Application for imported drug sub -packaging，It should be submitted in the expiration of the drug "Imported Drug Registration Certificate" or "Medical Product Registration Certificate"。

Article 98 Overseas pharmaceutical manufacturers shall sign the imported drug sub -packaging contract with domestic drug manufacturers，Fill in the "Application Form for Drug Supplement"。

Article 99 Application of imported drugs and packaging，It should be provided by the pharmaceutical manufacturers of the sub -packaging to the local area、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government submits an application，Submit "Application Form for Drug Supplement" filled in by the commissioner，Submit relevant information and samples。Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government will conduct formal review of the application information，Regulations of Article 51。

Provincial、Autonomous Region、After the drug supervision and management department of the municipality directly under the Central Government proposes the review opinion，Submit the application information and review opinions to the National Food and Drug Administration for approval，notify the applicant at the same time。

Article 100 of the State Food and Drug Administration reviews the information submitted for，Meeting the prescribed，Send to "Drug Supplement Application Application" and the drug approval number; if it does not meet the requirements，Send to the "Notice of Approval Opinions"，Explain the reason。

Pharmaceuticals of imported sub -packaging packaging should be implemented with imported drug registration standards。

The instructions and labels of Article 102 of imported packaging drugs must be consistent with the instructions and labels of imported drugs，and the name of the approved number and the name of the sub -packaging drug production enterprise should be marked。

Article 103 The import inspection of large overseas packaging preparations shall be implemented in accordance with the relevant provisions of the State Food and Drug Administration。Packaging product inspection and import inspection execution of the same drug standard。

Article 104 Overseas pharmaceutical manufacturers who provide medicines shall be responsible for the quality of the drug after sub -packaging。The quality of the medicines after the packaging，National Food and Drug Administration can revoke the approval number of sub -packaging drugs，If necessary，"Imported Drug Registration Certificate" or "Medical Product Registration Certificate"。 

Chapter 7

Article 105 Applying for imitation medicines is managed by non -prescription drugs，The applicant shall add the & quot;。

Article 106 Application of imitation medicines belongs to the management of prescription drugs and non -prescription medicines at the same time，Applicants can choose to apply in accordance with the requirements of prescription drugs or non -prescription drugs。

stake betting appArticle 107 belongs to the following situation，Applicants can add the & quot;，Compliance with the relevant regulations of the non -prescription drugs，Approval and management according to non -prescription drugs; not in compliance with the relevant provisions of non -prescription drugs，According to prescription drug approval and management。

(1) A non -prescription drug changing dosage formation determined by the State Food and Drug Administration，But without changing indications or functions、Drugs and medicines for dosage and administration;

(2) New compound preparations composed of non -prescription drug activity composed of the State Food and Drug Administration。

Application for registration of 108 non -prescription medicines，Its drug manuals and packaging labels shall comply with the relevant regulations of non -prescription medicines。

Pharmaceuticals imported from Article 109 belong to the non -prescription medicine，Application and approval procedures for imported drugs，Its technical requirements are the same as the non -prescription medicine produced in the country。 

Chapter 8

Article 130 changes to develop new medicines、Production drugs and imported drugs have been approved by the approved document and the matters stated in its attachments，It should be submitted for supplementary applications。

The applicant shall refer to the relevant technical guidance principles，Evaluate its changes for drug safety、Effects of effectiveness and quality controllability，Perform corresponding technical research work。

Article 131 The applicant shall fill in the "Drug Supplement Application Form"，province in your place、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government submits relevant information and instructions。Same as 76th。

Article 132 Supplementary Application for Imported Drugs，The applicant shall submit relevant information and instructions to the State Food and Drug Administration，Submit a document for the change of the change of drug management agencies in production countries or regions。The State Food and Drug Administration conducts formal review of the application information，Same as 51st。

Article 113 Modify the Standards for Registration of Drugs、Auxiliary materials that have medicinal requirements in the prescription of the drug、Supplementary applications that change the production process that affects the quality of drugs，From the province、Autonomous Region、After the drug supervision and management department of the municipality directly under the Central Government proposes the review opinion，Submitted to the National Food and Drug Administration for approval，notify the applicant at the same time。

Modify the supplementary application of the registration standard of drugs，Standard review by the Pharmaceutical Inspection Institute if necessary。

Article 114 Change the name of domestic drug production enterprises、Change the validity period of domestic production drugs、Supplementary applications for changing drug production venues in domestic drug production enterprises，From the province、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government is accepted and approved，Meeting the prescribed，Send to "Drug Supplement Application Application"，and submit it to the State Food and Drug Administration for record;，Send to the "Notice of Approval Opinions"，Explain the reason。

Article 115 Change Drug Packaging Tags in accordance with regulations、Modify the supplementary application for modification instructions according to the requirements of the State Food and Drug Administration，Report province、Autonomous Region、Drug supervision and management department of municipalities directly under the Central Government。

Article 116 Supplementary Application for Imported Drugs，Approval by the State Food and Drug Administration。Among them, the origin of the raw medicine used to change the imported drug preparations、Change the appearance of imported drugs but does not change drug standards、Modify the instructions of the oral medicine in accordance with the requirements of the national drug standards or the requirements of the State Food and Drug Administration、Supplement and improve the safety content of the imported drug manual、Change the imported drug packaging label in accordance with regulations、Change the imported drug packaging label in accordance with regulations，File by the State Food and Drug Administration。

Article 117 Transfer on drug production technology、Supplementary application for changing prescriptions and production processes may affect product quality, etc.，Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall be based on its "Drug Registration and Approval" attachment or approved production process，Organize the production site inspection，Drug Inspection Institute should test the 3 batch of samples extracted。

Article 118 The State Food and Drug Administration reviews the application of drug supplementary applications，If necessary, you can ask the applicant to supplement the information，Explain the reason。Meeting the prescribed，Send to "Replenishment Application Application"; if it does not meet the requirements，Send to the "Notice of Approval Opinions"，Explain the reason。

Article 119 After the application for supplementary application is approved，The Certificate of Approval Certificate for Drugs，The original drug approval certificate is canceled by the State Food and Drug Administration;，The original approved certification file continues to be valid。

Chapter 9

Article 120 The drug approval number issued by the State Food and Drug Administration、"Import Drug Registration Certificate" or "Medical Product Registration Certificate" is valid for 5 years。Validity period expires，You need to continue production or import，The applicant shall apply for re -registration at 6 months before the validity period expires。

Article 121 In the drug approval number、"Import Drug Registration Certificate" or "Medical Product Registration Certificate" is valid for its validity period，The applicant should have the safety of drugs、Effectiveness and quality control，Research results such as during the monitoring period、Monitoring of adverse reactions、Mesom of production control and product quality for system evaluation。

Article 122 of the drug re -registered application to apply to the province with the holder of the drug approved number、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government proposed，Fill in the "Application Form for the Registration of Drugs" in accordance with regulations，Provide relevant application information。

The re -registration application for imported drugs is submitted to the applicant to the State Food and Drug Administration。

Article 123 province、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government reviews the application information，Meeting the requirements，issue a notice of receiving the application for re -registration of medicines;，Sending medicines and re -registration applications will not be accepted，Explain the reason。

Article 124 province、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall review the re -registration of drugs within 6 months from the date of acceptance of the application，Meeting the prescribed，Registered again; if it does not meet the requirements，Report to the State Food and Drug Administration。

Article 125 The re -registration application of imported drugs is accepted by the State Food and Drug Administration，and complete the review within 6 months，Meeting the prescribed，Registered again; if it does not meet the requirements，Notice that will not be registered for re -registration，Explain the reason。

Article 126 The medicines with one of the following situations will not be registered again:

(1) If you have not submitted a re -registration application before the expiration of the validity period;

(2) The relevant requirements put forward by the State Food and Drug Administration's approval of the listing of the State Food and Drug Administration;

(3) If the phase IV clinical trial is not completed as required;

(4) If the drug adverse reaction monitoring is not performed in accordance with regulations;

(5) The re -evaluation of the State Food and Drug Administration is uncertainty、Bad reactions or other reasons to endanger human health;

(6) The Drug Management Law shall be revoked to the drug approval document;

(7) If there is no production conditions stipulated in the Drug Management Law;

(8) If the monitoring period is not fulfilled in accordance with regulations;

(9) Other circumstances that do not meet the relevant regulations.

Article 127 The State Food and Drug Administration received the province、Autonomous Region、After the opinions of the drug supervision and management department of the municipality directly under the Central Government，The review does not meet the register of the drug and register，Notice that will not be registered for re -registration，Explain the reason。

For a variety that is not registered，Except for the legal reasons for the revocation of the drug approval document，When the expiry of the validity period，Logging out its drug approval number、"Import Drug Registration Certificate" or "Medical Product Registration Certificate"。 

Chapter 10

Article 128 Drug Registration Inspection，Including sample inspection and drug standard review。

Sample inspection，refers to the inspection of the sample in accordance with the applicant's declaration or the drug standard approved by the State Food and Drug Administration。

Drug Standard Review，refers、Science、Whether the items and indicators set by the set can control the quality of the drug to perform the laboratory inspection and review work。

Article 129 Drug Registration Inspection Inspection Institute or Provincial Pharmaceutical Biological Products、Autonomous Region、Drug Inspection Institute of the Municipality directly under the Central Government。The registration inspection of imported drugs is implemented by the Chinese Pharmaceutical Biological Products Institute。

Article 130 The registered inspection of the following drugs is borne

(1) These Measures Article 45 (1)、(2) Pharmaceuticals specified;

(2) biological products, radioactive drugs;

(3) Other drugs stipulated by the State Food and Drug Administration。

Article 131 Pharmaceuticals that have been allowed to enter special approval procedures，Drug Inspection Institute should give priority to sample inspection and drug standard review。

Article 132 Pharmaceutical Inspection Institute，It should be in accordance with the laboratory quality management specifications and national measurement certification requirements of the drug inspection institute，Equipped with personnel and equipment that is compatible with drug registration inspection tasks，The quality assurance system and technical requirements that meet the drug registration test。

Article 133 The applicant shall provide the relevant information required for the drug registration inspection、Submit a sample or use the sample for inspection for inspection、Provide standard substance for inspection。The amount of samples submitted or extracted should be 3 times the amount of inspection; the registration inspection of biological products should also provide a corresponding batch of manufacturing verification records。

Article 134 Drug Inspection Institute Review of the New Drug Standard，Except for sample inspection，It should also be based on the research data of the drug、Drug standards and national requirements for similar products at home and abroad，Standards for drugs for drugs、Inspection items, etc. to propose review opinions。

Article 135 required the applicant to re -make the drug standard，The applicant shall not entrust the research work of the pharmaceutical inspection institute of the original review opinion;。

Chapter 11

Article 136 National Drug Standard，refers to the "Pharmacopoeia of the People's Republic of China" promulgated by the State Food and Drug Administration、Drug registration standards and other drug standards，Its content includes quality indicators、Testing methods and production processes and other technical requirements。

Drug registration standard，refers to the standard for the State Food and Drug Administration to approve the applicant's specific drugs，Pharmaceutical manufacturers who produce the drug must implement the registered standard。

Drug registration standards must not be lower than the regulations of Chinese Pharmacopoeia.

Article 137 of the projects of drug registration standards and the setting of their testing methods，It should meet the basic requirements of Chinese Pharmacopoeia、The technical guidance principles released by the State Food and Drug Administration and the principle of writing of national drug standards。

Article 138 The applicant shall be elected to take representative samples for standard research work。

Article 139 Drug standards，refers，Have a certain amount of characteristic value，Used for calibration equipment、Evaluation measurement methods or substances assigned to the drug for testing medicines，Including standard products、control products、control medicinal materials、Reference。

Article 140 The Chinese Drug Biological Products Investment Office is responsible for calibrating the standard of national drugs。

China Pharmaceutical Biological Products Institute can organize related provinces、Autonomous Region、Drug Inspection Institute of Municipality directly under the Central Government、Pharmaceutical research institutions or pharmaceutical manufacturers cooperate。

Article 141: The standard substance of the Chinese Pharmaceutical Biological Products Institute is responsible for the selection of standard substances from raw materials、Preparation method、calibration method、calibration results、Fixed value accuracy、Tracing of quantity value、Stability and packaging and packaging conditions for comprehensive technical review，Conclusion whether it can be used as a national drug standard material。

Article 142 The name of the application for registered medicines、Manual and label shall comply with the provisions of the State Food and Drug Administration。

Article 143 Pharmaceuticals and labels shall be proposed by the applicant，The Drug Review Center of the State Food and Drug Administration will review the content except the information of the corporate information.，Approved by the National Food and Drug Administration when approved drug production。

The applicant shall be the scientific nature of the drug manual and label、Standardity and accuracy Responsible。

Article 144 The applicant shall track the safety and effectiveness of the drug after listing，Timely submitting supplementary applications to modify the drug manual。

Article 145 The applicant shall be in accordance with the format and requirements stipulated by the State Food and Drug Administration、Print and label according to the approved content。 

Chapter 12

Article 146 The drug supervision and management department shall abide by the "Drug Management Law"、The Pharmaceutical Registration Time Equipment requirements stipulated in the "Administrative License Law" and the "Regulations on the Implementation of the Drug Administration Law"。The pharmaceutical registration time limit referred to in these Measures，Is the acceptance of drug registration、Review、The longest time for approval，Time to stop approval or supplementary information of applicants in accordance with the provisions of the laws and regulations or the applicant's supplementary information is not calculated。

Drug registration test、Review working hours shall be implemented in accordance with the requirements of these Measures。If there are special reasons, you need to extend the time，Should explain the reason，Report to the State Food and Drug Administration for approval and inform the applicant。

Article 147 The drug supervision and management department receives the application for formal review，and processed according to the following situations:

(1) Application matters do not need to obtain administrative license，shall immediately inform the applicant that the applicant will not be accepted;

(2) The application matters do not belong to the scope of the authority of the headquarters，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;

(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 5 days，If you do not inform overdue，It will be accepted since the date of receiving the application information;

(5) The application matters belong to the scope of the authority of the headquarters，Reporting information is complete、In line with statutory forms，or the applicant submits all correction information，stake sports betting appDrug registration application should be accepted。

The drug supervision and management department accepts or does not accept the application for drug registration，Written vouchers should be issued with special seals stamped with drug registration and the date of indicating the date。

Article 148 Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall complete the verification of the research and development and original information within 30 days after the application application、Review of the application information、Sample、Notification of the Drug Inspection Institute for a registered inspection、The review opinion and verification report, together with the applicant's application information, also submit it to the State Food and Drug Administration，The applicant will be notified at the same time。

Article 149 The time of the registration test of the drug shall be implemented in accordance with the following regulations:

(1) Sample inspection: 30th; Sample inspection and standard review at the same time: 60 days;

(2) Sample inspection of special medicines and vaccine products: 60 days; Sample inspection and standard review at the same time: 90 days。

According to the provisions of Article 36 of these Measures, the clinical trial sample test is performed by the Drug Inspection Institute，It should be completed according to the time inspection of the previous sample。

Article 150 The working hours of technical review shall be implemented in accordance with the following regulations:

(1) New drug clinical trial: 90th; varieties that are allowed to enter special approval procedures: 80 days;

(2) New drug production: 150 days; varieties that are allowed to enter special approval procedures: 120 days;

(3) Application for changing dosage forms and generic drugs for drugs that has been listed: 160 days;

(4) Replenishment application for technical review: 40 days。

The technical review time of imported stake sports betting appDrug registration applications refer to the previous paragraph。

Article 151 The need for applicants to supplement the information during the technical review process，Should issue a supplementary information notification，The applicant puts forward the objection to the content of the supplementary information，You can listen to the applicant's statement in person。The applicant shall complete the supplementary information at one time within 4 months in accordance with the notification requirements，Enter the special approval procedure，Course according to the requirements of the special approval procedure。

After receiving the supplementary information，The time of technical review should not exceed 1/3 of the original specified time; enter the special approval procedure，It must not exceed 1/4 of the original specified time。

During the pharmaceutical registration process, the applicant submits its own withdrawal application，Its approval procedure is terminated by itself。

Article 152 The State Food and Drug Administration shall make an approval decision within 20 days;，Approved by the leaders of the competent Bureau，Can be extended for 10 days，and the reason to inform the applicant of the reasons for extending time limit。

Article 153 The State Food and Drug Administration shall be issued within 10 days from the date of the decision to make a drug registration approval decision、Deliven the relevant administrative license documents。

Chapter 13

Article 154 There is one of the following situations，The National Food and Drug Administration will not be approved:

(1) Research materials submitted by different applicants、The same or the same data，There is no justified reason;

(2) During the registration process, it is found that the application information is not true，The applicant cannot prove that their declaration information is true;

(3) Research project design and implementation cannot support the safety of applying for drugs、Effective、Evaluation of quality controllability;

(4) Application information shows that its application for drug safety、Effective、Quality controllability, etc. There are great defects;

(5) If you fail to supplement the information within the prescribed time limit;

(6) The source of the raw and drug does not meet the regulations;

(7) If the production site inspection or sample inspection results do not meet the requirements;

(8) Other situations that should not be approved by laws and regulations。

Article 155 The drug supervision and management department makes a written decision that does not accept or approve it，Should explain the reason，and inform the applicant to enjoy the right to submit administrative reconsideration in accordance with the law or file an administrative lawsuit。

Article 156 The applicant's non -approval decision to obtain objection to the State Food and Drug Administration，You can fill in the "Application Form for Drug Registration Review"，Possesses the application for review to the State Food and Drug Administration and explain the re -trial。

The content of the review is limited to the original application items and the original application information.

Article 157 After the National Food and Drug Administration receives a review application，The review decision should be made within 50 days，and notify the applicant。Maintain the original decision，The National Food and Drug Administration will no longer accept the re -review application。

Article 158 The review requires technical review，The National Food and Drug Administration shall organize relevant professional and technical personnel to conduct in accordance with the original application time limit。