Measures for the Supervision and Management of Drug Production
（January 22, 2020 announced on the 28th of the State Administration of Market Supervision and Administration)
Chapter 1 Total Jeebu
The first article To strengthen the supervision and management of drug production，Standardized drug production activities，According to the "Drug Management Law of the People's Republic of China" (hereinafter referred to as the "Drug Management Law")、"Traditional 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。
Two The production and supervision and management of drugs listed drugs in the People's Republic of China，It should abide by these Measures。
Article 3 engaged in drug production activities，It should abide by the law、Regulations、Regulations、Standards and specifications，Make sure the whole process information is true、Accurate、Complete and traceable。
engaged in drug production activities，The province of where is located、Autonomous Region、Approval of the drug supervision and management department of municipality directly under the Central Government，Obtain a drug production license in accordance with the law，Strictly abide by the quality management specifications of drug production，Make sure the production process continues to meet the legal requirements。Pharmaceutical listing permit holders shall establish a drug quality assurance system，Performing the responsibility for the release of drugs，Responsible for the quality of the medicine for obtaining a drug registration certificate for it。
Traditional Chinese medicine beverage production enterprises shall fulfill the relevant obligations of the drug listing license holder，Make sure the production process of Chinese medicine decoction continues to meet statutory requirements。
The raw and drug production enterprise shall organize production in accordance with the approved production process，Strictly abide by the quality management specifications of drug production，Make sure the production process continues to meet the legal requirements。
Auxiliary materials for reviewed by related review、Production enterprises that directly contact the packaging materials and containers of drugs, as well as other units and individuals engaged in drug -related production activities in accordance with the law。
Article 4 Pharmaceutical listing license holder、Drug production enterprises shall establish and implement the pharmaceutical traceability system，Retanement logo of the sales packaging unit at all levels of drugs at all levels，Implementation of drug traceability through informationization，Timely and accurate record、Save Drug Traceability Data，and provide traceability information to the drug traceability cooperative service platform。
Article 5 The head of the National Drug Administration in charge of the national pharmaceutical production supervision and management，For province、Autonomous Region、Drug production supervision and management of the drug supervision and management department of the municipality directly under the Central Government conducts supervision and guidance。
Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government is responsible for the supervision and management of drug production supervision in the administrative area，Licensing of the drug production link、Check and punishment。
Food and Drug Review and Inspection Center of the State Drug Administration (hereinafter referred to as the inspection center) organized the formulation of technical specifications and documents for drug inspection，undertaking overseas inspections and organizational vaccine inspections，Analysis Evaluation Inspection Discover Risk、Make a check conclusion and make suggestions for disposal，Responsible for provinces、Autonomous Region、Guidance and evaluation of the quality management system of the drug inspection institution directly under the Central Government。
The Information Center of the State Drug Administration is responsible for the pharmaceutical traceability collaborative service platform、Pharmaceutical safety credit file construction and management，Uniform coding of drug production venues。
Drug Supervision and Administration Department sets or designated drug reviews in accordance with the law、Test、Check、Monitoring and Evaluation and other professional and technical institutions，Take responsibility to take relevant technical work and issue technical conclusions，Provide technical support for drug production supervision and management。
Chapter 2 Production license
Article 6 engaged in drug production, the following conditions should be met:
(1) Pharmacy and technicians with qualifications in accordance with the law、Engineering and technical personnel and corresponding technical workers，Legal representative、Corporate person in charge、The person in charge of production management (hereinafter referred to as the person in charge of production)、Quality Management person in charge (hereinafter referred to as the person in charge of quality)、Quality subjects and other related personnel meet the conditions stipulated in the Drug Management Law and the Vaccine Management Law;
(2) There are factories that are compatible with drug production、Facilities、Equipment and sanitary environment;
(3) Organization of quality management and quality inspection of the drugs produced、Personnel;
(4) The necessary instruments and equipment that can perform quality management and quality inspection of the drugs produced;
(5) rules and regulations with the quality of drugs，and meet the requirements of the quality management specifications of drug production。
for vaccine production activities，It should also have the following conditions:
(1) Have a moderate scale and sufficient capacity reserves;
(2) A system and facilities with guarantee biological safety、Equipment;
(3) meets the needs of disease prevention and control.
Article 7 Effective preparations、APIP、Production of Chinese Medicine Drinking Film，The applicant shall be in accordance with these Measures and the requirements of the application information stipulated in the State Drug Administration，province in your place、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government will apply。
Pharmaceutical listing permits entrusted by others to produce preparations，It should be possessed Article 6 of these Measures、Third Item、Condition specified in the fifth item，and sign a commission agreement and quality agreement with eligible pharmaceutical manufacturers，Merge and submit the application information of the relevant agreement with the actual production site to the province where the holder of the drug listing license is located、Autonomous Region、Drug supervision and management department of municipality directly under the Central Government，Apply for a drug production license in accordance with the provisions of these Measures。
The applicant shall be responsible for the authenticity of the entire content of its application materials。
Article 8 Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government receives the application，It should be processed according to the following situations:
(1) The application is not belonging to the scope of the authority of the headquarters in accordance with the law，Should make decisions that are not accepted immediately，and inform the applicant to apply to the relevant administrative agency;
(2) The application matters do not need to obtain administrative license in accordance with the law，It should be informed of the applicant not accepted immediately;
(3) The existence of the application materials can be correct on the spot，The applicant should be allowed to correct on the spot;
(4) Application materials are incomplete or not in line with formal review requirements，The notice of correction materials for the applicant should be issued on the spot or within five days，All content that the applicant needs to be corrected，If you do not inform overdue，It will be accepted since the date of receiving the application materials;
(5) Application materials are complete、Compliance with formal review requirements，or the applicant submits all correction materials，Acceptance。
Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government accepts or does not accept the application for drug production license，The notice of acceptance of the dedicated seal and the date of indicating the date of the department shall be issued or not a notice of acceptance。
Article 9 Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall be within 30 days from the date of acceptance，Make a decision。
The review meets the requirements，Approve it，and a drug production license will be issued within 10 days from the date of the decision of writing in writing;，Make a written decision without approval，Explain the reason。
Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Gube、On -site inspection。
Article 10 Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall publicize the conditions required to apply、Program、Duration、Directory and application for all materials to be submitted。
Provincial、Autonomous Region、The relevant information of the drug production license issued by the drug supervision and management department of the municipality directly under the Central Government，It should be made public，The public has the right to check。
Article 11 Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government will review the application for the application of a drug production license，The results of the approval should be publicly public，Provide conditions to facilitate the applicant to inquire about the approval process。
Without the consent of the applicant，Drug Supervision and Management Department、Professional and technical institutions and their staff shall not disclose the business secrets submitted by the applicant、Unveiled information or confidential business information，The law has other provisions or involved in national security、Except for the public interests of major society。
Article 12 Applying for the drug production license directly involves the significant interest relationship between the applicant and the others，Applicant、Persons with interest relationships in accordance with the law、Regulations stipulate that you have the right to apply for hearing。
When reviewing the application of drug production enterprises，Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government believes that it involves public interests，Shake of announcement to the society，Hold a hearing。
Article 13 Drug production license is valid for five years，Divided into the original and copy。Drug stake online sports bettingStake Sports Bettingproduction license style is formulated by the State Drug Administration。Drug production license electronic certificate and paper certificate have the same legal effect。
Article 14 Drug production permits shall contain the license number、Classification code、Corporate name、Unified social credit code、Residence (operating venue)、Legal representative、Corporate person in charge、The person in charge of production、Quality person in charge、Quality I am rightistors、Production address and production range、The issuance authority、issuance of a certificate、Validity period and other items。
Corporate name、Unified social credit code、Residence (operating venue)、Projects such as legal representatives and other projects shall be consistent with the relevant contents of the business license issued by the market supervision and management department。
Article 15 Drug production permits stated that matters are divided into permit matters and registration items。
License refers to the production address and production scope.
Registration items refer to the name of the enterprise、Residence (operating venue)、Legal representative、Corporate person in charge、The person in charge of production、Quality person in charge、Quality Isersators, etc.。
Article 16 Change drug production license permit，Application for changing drug production licenses to the original issuance authority。Unexpectedly，Do not change the license matters without authorization。
The original issuance authority shall make a decision to make a permitted change within 15 days from the date of receiving the application of the corporate change。No change，Should be explained in writing，and inform the applicant's right to apply for administrative reconsideration in accordance with the law or file an administrative lawsuit。
Change the production address or the scope of production，Drug production enterprises shall be in accordance with the provisions of Article 6 of these Measures and related technical requirements for changing，Submit related materials involving changes，Also reported to the location of the Scripture、Autonomous Region、The censorship decision of the drug supervision and management department of the municipality directly under the Central Government。
Original or new、Step、Expansion of the workshop or production line，It should meet relevant regulations and technical requirements，Submit related materials involving changes，Also reported to the location of the Scripture、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government conducts drug production quality management specifications and compliance inspections，Inspection results shall notify the enterprise。The results of the inspection meet the requirements，Products can be listed and sold if they meet the release requirements。Relevant changes，It should be stated in the copy of the drug production license。
The above -mentioned changes involve the drug registration certificate and its attachment containing the content，From the province、Autonomous Region、After approval of the drug supervision and management department of the municipality directly under the Central Government，Report the Drug Review Center of the State Drug Administration to update the drug registration certificate and its attachment related content。
Article 17 Change the registration of drug production licenses，It should be approved by the market supervision and management department or within 30 days after the company is completed，Applying for a pharmaceutical production license change registration from the original issuing authority。The original issuance authority shall go through the change procedures within ten days from the date of receiving the application of the company's change。
Article 18 After changing the drug production license，The original certificate agency shall record the content and time of the change on the copy of the drug production license，and re -issue the original drug production license of the drug production permit，Recover the original drug production license，The termination period of the pharmaceutical production license of the change is unchanged。
Article 19 Drug production license validity period expires，You need to continue to produce medicines，It should be six months before the expiration of the validity period，Apply to the original issuing authority to re -issue drug production licenses。
The original certificate organs combined with enterprises to comply with drug management laws and regulations、Drug production quality management specifications and quality system operation，Review according to the principle of risk management，Decisions for whether to make a re -issuing certificate before the expiration of the pharmaceutical production license。In line with the regulations, it is allowed to re -issue a certificate，Recover the original certificate，Re -issue a certificate; if it does not meet the prescribed，Make a written decision that does not re -issue a certificate，Explain the reason，At the same time, inform the applicant's right to apply for administrative reconsideration in accordance with the law or file an administrative lawsuit;，deemed to be re -issued by consent，Course the corresponding procedures。
Article 20 There is one of the following situations，Drug production license is sold by the original certificate agency，An announcement:
(1) For the active application for cancellation of the drug production license;
(2) Drug production licenses have not re -issued a certificate over expiry;
(3) The business license is revoked or canceled according to law;
(4) Drug production licenses were revoked or revoked according to law;
(5) Law、Regulations stipulate that other circumstances shall cancel administrative licenses。
Article 21 Drug production license is lost，Pharmaceutical listing license holder、Drug production enterprises should apply to the original certificate authority to replenish，The original issuance organs replenish the drug production license within 10 days in accordance with the original approval matters。License Number、Validity period, etc. is consistent with the original license。
Article 22 No unit or individual may not forge、STC、rental、Lending、Sale of drug production licenses。
Article 23 Provincial、Autonomous Region、The drug supervision and management department of municipality directly under the Central Government shall issue the drug production license、Re -issuance、Change、Replenishment、A revocation、Return、Logging out and so on，Update in the drug safety credit file within ten days after the work is completed。
Chapter 3 Production Management
Article 24 engaged in drug production activities，It should abide by the quality management specifications of drug production，According to national drug standards、Pharmaceutical registration standards and production processes approved by the drug supervision and management department for production，Submit and update venue management documents，Risk assessment and continuous improvement of the operation process of the quality system，Make sure the entire process of drug production continues to meet the legal requirements。Production、Inspection and other records should be complete and accurate，No fabrication and tampering。
Article 25 Vaccine listing permit holder shall have vaccine production、Check the necessary factory facilities and equipment for inspection，Equipped with qualified managers，Establish a perfect quality management system，With the ability to produce the vaccine that meets the registration requirements，Excessive vaccine production capacity really needs to be commissioned for production，It shall be approved by the State Drug Administration。
Article 26 engaged in drug production activities，It should abide by the quality management specifications of drug production，Establish and improve the quality management system of drug production，All factors affecting the quality of drugs，Make sure the entire process of drug production continues to meet the legal requirements。
Article 27 Pharmaceutical listing permit holders shall establish a drug quality assurance system，Equipped with specialized personnel independently responsible for drug quality management，For the trustee drug production enterprise、The quality management system of drug business enterprises conduct regular review，Supervise its continuous quality assurance and control ability。
Article 28 The legal representative of the holder of the drug listing permit、The main person in charge shall be fully responsible for the quality of the medicine，Performing the following responsibilities:
(1) Equipped with special quality responsible for the quality management of drug quality;
(2) Equipped with the responsibility for the release of the drug listing independently by the person with special quality;
(3) The supervision quality management system runs normally;
(4) For drug production enterprises、Suppliers and other related parties and drug production related activities regularly carry out quality system review，Guaranteed continuous compliance;
(5) According to the technical requirements of the change，Performing the responsibility for changing management;
(6) Make quality assessment of the commissioned business enterprise，Communicate information with the unit, etc.;
(7) Extension of the drug supervision and management department on the drug listing license holder and related parties;
(8) Major safety events related to the quality of drugs occur，It should be reported in a timely manner and carried out risk disposal in accordance with the risk management plan developed by the holder，Make sure the risks are controlled in time;
(9) The responsibilities stipulated in other laws and regulations.
Article 29 Legal representative of drug manufacturers、The main person in charge shall be fully responsible for the company’s drug production activities，Performing the following responsibilities:
(1) Equipped with dedicated quality leaders independently responsible for drug quality management，Supervision Quality Management Specification Execution，Make sure appropriate production process control and quality control，Make sure that drugs meet national drug standards and drug registration standards;
(2) Equipped with specialized quality, the performers performed the responsibility for the release of drugs for the release of the medicine;
(3) The supervision quality management system is running normally，Guarantee control of drug production process、Quality control and record and data authenticity;
(4) Major safety events related to drug quality occurred，It should be reported in time and carried out risk disposal in accordance with the risk management plan set by the enterprise，Make sure the risks are controlled in time;
(5) The responsibilities stipulated in other laws and regulations.
Article 30 Pharmaceutical listing license holder、Drug production enterprises shall conduct health inspections and establish a health file，Avoid people who have infectious diseases or other people who may pollute drugs to engage in production activities that direct contact with drugs。
Article 31 Pharmaceutical listing license holder、Drug production enterprises are in drug production，Risk assessment should be carried out、Control、Verification、Communication、Audit and other quality management activities，Take effective risk control measures in time for recognized risks，To ensure product quality。
Article 32 engaged in drug production activities，The raw medicine should be used for use、Accessories、Packaged materials and containers such as direct contact with drugs or containers or manufacturers for review，Guaranteed purchase、Use the requirements of the regulations。
The raw materials required for production drugs、Accessories，The relevant requirements of the medicinal requirements and the corresponding production quality management specifications should be met。Packaged materials and containers of direct contact with drugs，It should meet the medicinal requirements，Conforming to protect human health、Standards for safety。
Article 33 APIs that have been approved or approved by related reviews、Accessories、Production enterprises that directly contact the packaging materials and containers of drugs，It should abide by the quality management specifications formulated by the State Drug Administration and the relevant requirements of related review review and approval，Make sure the quality assurance system is continuous compliance，The quality review of the holder of the drug listing permit，Under the supervision and inspection of the drug supervision and management department or extension inspection。
Article 34 Drug production enterprises should determine the confirmation and verification that needs to be made，Implementing according to the confirmation and verification plan。Regular Stake Sports Bettingfacilities、My stake betting appEquipment、Production process and cleaning method for evaluation，Confirm that its continuous maintenance status。
Article 35 Drug production enterprises should take prevent pollution、Cross pollution、Control measures of confusion and error，Regular inspection and evaluation control measures for the applicability and effectiveness of the control measures，，and meet the requirements of the quality management specifications of drug production。
Drug listing permit holders and pharmaceutical manufacturers shall not produce other products that have adverse effects on drug quality in the drug production plant。
Article 36 Drug packaging operations should take measures to reduce confusion and error risks，Drug packaging should ensure that the drug storage and transportation process within the validity period is not contaminated。
The expression in the pharmaceutical manual and label should be scientific、Specification、Accurate，Text should be clear and easy to distinguish，No paste must be pasted、Cutting、Modes of modification to modify or supplement。
Article 37 Drug manufacturers should establish a drug -out factory release regulations，Clear standards for factory release、Condition，and test results of the quality of drugs、Key production records and deviation control situations for review，Quality inspection of medicines。Meet the standard、Condition，After the signing of the quality of the person in charge, the factory can be released。
Drug listing permit holders shall establish a drug listing release regulations，Review the results of the drug inspection and release files of the pharmaceutical manufacturer's factory release，After the signature of the quality of the authority, it can be released to release。
Chinese medicine drinking tablets meet national drug standards or provinces、Autonomous Region、The production specifications formulated by the drug supervision and management department of the municipality directly under the Central Government，、Sales。
Article 38 Pharmaceutical listing license holder、Drug production enterprises should conduct self -examination every year，Monitor the implementation of the quality management specifications of drug production，Evaluate whether the enterprise meets the requirements of relevant regulations，and propose necessary corrective and preventive measures。
Article 39 Drug listing permit holders shall establish an annual report system，According to the regulations of the State Drug Administration, to the province every year、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government Reports drug production and sales、Research after listing、Risk management, etc.。
Vaccine listing permit holders shall conduct annual reports to the State Drug Administration in accordance with regulations。
Article 40 Drug listing permit holders shall continue to carry out drug risk benefit evaluation and control，Formulate the drug risk management plan after listing，Research after actively carried out listing，Safety of drugs、Effectivity and quality controller further confirm，Strengthen the continuous management of listed medicines。
Article 41 Drug listing permit holders shall establish a drug alert system，Carry out drug alert work in accordance with the standardized quality management specifications formulated by the State Drug Administration。
Pharmaceutical listing license holder、Drug production enterprises should often examine the quality of the drug in the unit、efficacy and adverse reactions。Discover suspected adverse reactions，It should be reported in time as required。
Article 42 Pharmaceutical listing license holder entrusted to produce drugs，It should meet the relevant regulations of drug management。
Drug listing license holder entrusted eligible pharmaceutical manufacturers to produce drugs，Evaluate the quality assurance and risk management capabilities of the trustee，According to the requirements of the drug commissioning production quality agreement formulated by the National Drug Administration，Signed a quality agreement with it and the commission agreement，Supervisor the obligation to fulfill the obligations stipulated in the relevant agreement。
The trustees must not entrust the drug to be commissioned to produce third -party production。
The raw medicines approved or approved or approved by related review should be produced by themselves，You must not entrust others to produce anymore。
Article 43 Drug listing permit holders shall manage and control the change of production process in accordance with the requirements of the quality management of drug production，and formulate procedures for formulating processes in accordance with the approved production process。The change of production process should be carried out for research，and obtain approval in accordance with the law、Report or report，Under the supervision and inspection of the drug supervision and management department。
Article 44 Pharmaceutical listing license holder、Drug production enterprises should conduct product quality review and analysis of the varieties they produce in accordance with the variety of products、Record，To confirm the stable and reliable process，and raw materials、Accessories、Applicability of the current quality standards of finished products。
Article 45 Pharmaceutical listing license holder、Organizations related to the quality management system of pharmaceutical manufacturers、Corporate person in charge、The person in charge of production、Quality person in charge、The quality of the quality authority is changed，It should be within 30 days from the date of change，Complete registration procedures。
Vaccine listing permit holder shall be within 15 days from the date of change，province in your place、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government reports the person in charge of production、Quality person in charge、Change of key positions such as Quality Extraordinary Responsible persons。
Article 46 Pharmaceuticals of short -vacancy drugs for the state -suspended report on the state，Drug listing license holder stops production，It should be provided to the local area six months before planning to be suspended and implemented.、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government;，Report the location of the place where the report is located、Autonomous Region、Drug supervision and management department of municipality directly under the Central Government。When necessary，Report to the State Drug Administration。
After receiving the report, the drug supervision and management department，It shall promptly notify the same -level shortage drug supply guarantee work will lead the unit。
Article 47 Drug listing permit holder is an overseas enterprise，A corporate legal person in China should be specified，Performing the obligations of the drug listing license holder stipulated in the "Drug Management Law" and these Measures，Responsible for coordinating and cooperating with overseas inspections。
Article 48 The production site of the holder of the drug listing permit is abroad，Organize production in accordance with the "Drug Management Law" and these Measures，With overseas inspection work。
Chapter 4 Supervision and inspection
Article 49 Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government is responsible for the holder of the drug listing permit in the administrative area，Preparation、Chemicals、Supervision and Management of Traditional Chinese Medicine Drinking Film Production Enterprises。
Provincial、Autonomous Region、The drug supervision and management department of municipality directly under the Central Government shall be raw materials、Accessories、Packaged materials and containers such as direct contact with drugs、Production enterprises carry out daily supervision and inspection，Extension inspection if necessary。
Article 50 Drug listing license holders and trustee manufacturers are not in the same province、Autonomous Region、Municipality，Prefecture, where the holder is located from the drug listing permit、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government is responsible for the supervision and management of the drug listing license holder，The province of the trustee production enterprise、Autonomous Region、The drug supervision and management department of municipality directly under the Central Government is responsible for supervision and management of trusted production enterprises。Provincial、Autonomous Region、The drug supervision and management department of municipality directly under the Central Government shall strengthen supervision and inspection information to notify each other，Timely update supervision and inspection information into drug safety credit files，You can conduct surveys based on the update of supervision information in the report and drug safety credit files，Administrative treatment of the holder of the drug listing permit or the trustee of the trustee，If necessary, you can carry out a joint inspection。
Article 51 The drug supervision and management department shall establish a sound professionalization、Specialized Inspector System，Clarify the qualification standard of the inspector、Checking responsibility、Grade Management、Ability training、Behavior specification、Performance evaluation and exit procedures，Improve the professional quality and work level of the inspector。Inspectors should be familiar with drug laws and regulations，Has the professional knowledge of drugs。
The drug supervision and management department shall be based on regulatory rights、Drug industry scale and inspection task, etc.，Equipped with sufficient inspectors，Safe inspection needs。Areas of high -risk pharmaceutical manufacturers such as vaccines，It should also be equipped with a drug inspector with the corresponding quantity of high -risk drug inspection skills and experience。
Article 52 Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government is according to supervision needs，Applicants and trustee production enterprises with drug listing licenses holding drug production licenses，According to the requirements of the following requirements, the quality management specifications before listing are compliant inspection:
(1) The varieties of the drug production quality management specifications that are not adapted to the production conditions of the drug，The quality management specifications of drug production before listing should be performed。Where，Drugs intended to produce drugs need to be checked at the site of drug registration，Notice Inspection Center of the Drug Review Center of the State Drug Administration，Inform relevant provinces、Autonomous Region、Drug supervision and management department and applicant of municipalities directly under the Central Government。Checking Center Coordinating relevant provinces、Autonomous Region、Drug supervision and management department of municipality directly under the Central Government，Simultaneous conducting drug registration site inspections and the quality management specifications of drug production before listing;
(2) Drugs to be produced do not need to be checked on the site of drug registration，The Pharmaceutical Review Center of the State Drug Administration informs the province where the production site is located、Autonomous Region、Drug supervision and management department and applicant of municipalities directly under the Central Government，Related provinces、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government will carry out the quality management specifications of drug production before listing;
(3) Variety of drug production quality management specifications that have been compatible with the production conditions of the drug in the drug，Related provinces、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government decides whether to carry out the quality management of drug production quality management specifications before listing。
Code for the quality management of drug production before listing，After the inspection is over，The inspection situation should be、Inspection results, etc. to form a written report，As an important basis for supervision of drug listing。Drug production quality management specifications before listing Code compliance inspection involving changes in drug production licenses，Provincial province from the primary certificate、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government makes a decision in accordance with the change procedure。
Commercial scale batch of business scale of the drug production quality management specifications before the corresponding listing，After obtaining a drug registration certificate，Those who meet the requirements of product release can be listed and sold。Drug listing license holders shall focus on strengthening the production and sales of the above batch drugs、Risk management and other measures。
Article 53 The main contents of the supervision and inspection of drug production include:
(1) Pharmaceutical listing permit holder、Pharmaceutical manufacturers implement relevant laws、Regulations and implementation of the quality management specifications of drug production、Drug alert quality management specifications and related technical specifications;
(2) Whether the drug production activities are consistent with the relevant content stated by the variety archives;
(3) Vaccine storage、Regulatory implementation of transportation management;
(4) Drug commissions production quality agreement and commission agreement;
(5) Implementation of the risk management plan;
(6) Change management.
Supervision and inspection stake sports betting appincludes stake online sports bettingpermit inspection、Conventional inspection、There is an inspection and other inspections。
Article 54 Provincial、Autonomous Region、The drug supervision and management department of municipality directly under the Central Government shall adhere to risk management、The principle of full management and control，According to risk research and judgment，Formulate the annual inspection plan and carry out supervision and inspection。Annual inspection plan includes at least the scope of inspection、Content、Method、Key points、Requirements、time limit、Organization of inspection, etc.。
Article 55 Provincial、Autonomous Region、The drug supervision and management department of municipality directly under the Central Government shall be based on the variety of drugs、Dosage form、Category of control category，Combined with the overall situation of national drug safety、Drug safety risk warning information、Major drug safety events and their investigation processing information, etc.，and past inspection、Test、Adverse reaction monitoring、Complaint reports and other conditions determine the frequency of inspection:
(1) For anesthesia drugs、The first category of psychotropic medicine、Pharmaceutical Easy toxic Chemical Production Enterprises are inspected not less than once in the quarter;
(2) Vaccine、Blood Products、Radioxids、Medical toxic drugs、High -risk drug production enterprises such as sterile drugs，No less than one year of drug production quality management specifications for compliance inspection;
(3) Pharmaceutical manufacturers outside the above products，Take a certain percentage of supervision and inspection every year，But the enterprises in the administrative region should be checked within three years;
(4) For raw materials、Accessories、Packaged materials and containers such as direct contact with drugs、Production enterprises take a certain percentage of supervision and inspection per year，Check all the enterprises in the administrative area within five years。
Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government can combine the actual situation of the drug production supervision work in the administrative area，Adjust the frequency of inspection。
Article 56 National Drug Administration and province、Autonomous Region、During the Organization of the Drug Supervision and Management Department of the Municipality directly under the Central Government，Inspection plan should be formulated，Clear inspection standard，Record the on -site inspection situation，The sampling test or research needs，Implement in accordance with relevant regulations。Inspection conclusions should be clear and clear，The problems found found in the inspection should be notified in writing。It needs rectification，The content of rectification and rectification should be proposed，Inspection after rectification when necessary。
During supervision and inspection，The drug supervision and management department shall assign more than two inspectors for supervision and inspection，Inspectors should show the law enforcement document to the inspector。Staff of the Drug Supervision and Administration Department should keep confidential about the business secrets that they know。
Article 57 During supervision and inspection，Pharmaceutical listing permit holders and drug manufacturers shall be explained according to the inspection needs、Provide relevant materials:
(1) Management documents and change materials for drug production venues;
(2) Drug production enterprises accept supervision, inspection and rectification implementation;
(3) The treatment of unqualified drug quality;
(4) Drug alert institution、Personnel、System formulation and suspected drug adverse reaction monitoring、Identification、Evaluation、Control situation;
(5) Implementation of qualified varieties，Materials for research after listing;
(6) Other necessary materials that need to be reviewed.
Article 58 After the on -site inspection is over，A summary of the on -site inspection should be analyzed，and objective、Fairness、Risk assessment of the defects found in the inspection in a fair way and make on -site inspection conclusions。
The unit is responsible for comprehensive research and judgment of the on -site inspection conclusion。
Article 59 National Drug Administration and province、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government finds that drug production management or vaccine storage、There are defects in transportation management，There is evidence to prove that there may be hidden dangers，Corresponding measures should be taken according to law:
(1) Basically meet the requirements of the quality management specifications of drug production，It needs rectification，Alert letter shall be issued and adopted accordingly according to the risk、Interview、Rectification and other measures for time limit;
(2) Drugs have quality problems or other hidden safety hazards，Drug Supervision and Administration Department according to supervision and inspection，Alert letter should be issued，and take a suspension of production according to the risk、Sales、Use、Import and other control measures。
Drugs have quality problems or other safety hazards，Drug listing permit holders shall recall the drugs in accordance with the law without recalling，Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall order it to recall。
After the risk is eliminated，The drug supervision and management department that takes control measures shall terminate the control measures。
Article 60 During the process of conducting drug production supervision and inspection，It is found that there is a drug quality and safety risk，It should be reported to the sent unit in time。The drug supervision and management department is judged to be a major drug quality and safety risk，Report to the drug supervision and management department and local people's government at the same level in time。
Article 61 During the process of conducting drug production supervision and inspection，It is found that there are suspected violation of drug laws、Regulations、Behavior of the rules，On -site control measures should be taken in time，Make evidence collection in accordance with regulations。The drug supervision and management department shall investigate and deal with it in accordance with the law and authority，Suspected crime transfer to public security organs for treatment。
Article 62 Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall attribute the supervision information of the drug listing license holder and the drug production enterprise in the administrative area according to law.，and maintain the dynamic update of related data。Regulatory information includes drug production licenses、Results of daily supervision and inspection、Investigation and punishment of illegal behavior、Drug quality spot check inspection、Bad behavior records and complaint reports。
Article 63 National Drug Administration and province、Autonomous Region、The drug supervision and management department of municipality directly under the Central Government is in production supervision and management，Do not hinder the drug listing permit holder、Normal production activities of pharmaceutical manufacturers，Do not ask for or accept property，Do not seek other interests。
Article 64 Personal and tissue found that the drug listing license holder or pharmaceutical manufacturer conducts illegal production activities，I have the right to report to the drug supervision and management department，The drug supervision and management department shall verify in a timely manner in accordance with relevant regulations、Treatment。
Article 65 major safety events related to drug quality occur，Drug listing permit holders shall immediately immediately treat relevant medicines and their raw materials、Accessories and packaging materials and containers that are directly exposed to drugs、Related production lines, etc. take control measures such as sealing，and immediately report the province where the location is located、Autonomous Region、The drug supervision and management department and relevant departments of the municipality directly under the Central Government，Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall report the provincial people's government within 24 hours，Report the State Drug Administration at the same time。
Article 66 Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government has a drug listing license holder with bad credit records、Drug production enterprises，The frequency of supervision and inspection should be added，and can be implemented in accordance with national regulations。
Article 67 Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government fails to discover the drug safety systemic risk of production links in time，Failure to eliminate hidden dangers in the supervision and management area，or the provincial people's government has not fulfilled drug safety responsibilities，Failure to eliminate hidden dangers of major regional drug safety hazards，The State Drug Administration shall make an interview with the principals of its main leaders。
The province interviewed、Autonomous Region、Drug supervision and management departments and local people's governments of municipalities and local people's governments shall immediately take measures，Rectification of drug supervision and management。
Interviews and rectifications should be included in the province、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government and the drug supervision and management of the local people's government、Evaluation Record。
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Chapter 5 Legal liability
Article 68 There is one of the following situations，Punishment shall be punished according to Article 115 of the Drug Management Law:
(1) Drug listing license holder and drug production enterprise change production address、The scope of production shall be approved without approval;
(2) Drug production license is still produced by the validity period and is still produced。
Article 69 Drug listing permit holders and drug manufacturers fail to produce in accordance with the requirements of drug production quality management specifications，There is one of the following situations，It belongs to the serious circumstances stipulated in Article 126 of the Drug Management Law，punishment according to law:
(1) The person who is not equipped with a special quality leader is independent responsible for drug quality management、Supervision quality management specifications;
(2) Drug listing license Hand holders are not equipped with specialized quality and performers to fulfill the responsibility for the listing of drugs;
(3) Drug manufacturers are not equipped with special quality.
(4) The quality management system cannot run normally，Drug production process control、Records and data of quality control are not real;
(5) The recognized risk of risk did not take effective risk control measures in time，Unable to guarantee product quality;
(6) Other cases that seriously violate the quality management of drug production。
Article 70 Accessories、Production enterprises and suppliers who directly contact the packaging materials and containers that are directly exposed to drugs have not complied with relevant requirements for quality management specifications formulated by the State Drug Administration，Can't ensure the continuous compliance of the quality assurance system，From the province of where it is、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall be punished in accordance with Article 126 of the Drug Administration Law。
71st item Drug listing license holder and drug manufacturer have one of the following circumstances，From the province of where it is、Autonomous Region、Pharmaceutical Supervision and Administration Department of the Municipality directly under the Central Government is fined 10,000 yuan to 30,000 yuan:
(1) Enterprise name、Residence (operating venue)、Legal representatives have not changed the registration matters in accordance with regulations;
(2) No health inspection and establishment of health files on staff who do not directly contact drugs every year in accordance with regulations;
(3) No drug discontinued reports for the shortage drug list that are included in the state of production suspension in accordance with regulations。
Article 72 The drug supervision and management department has one of the following behaviors，Punishment of the person in charge and other direct responsible persons in accordance with Article 149 of the Drug Management Law:
(1) concealment、Lie Bao、Slow report、Demonstration of drug safety incidents;
(2) The drug safety illegal behavior found did not investigate and deal with it in time;
(3) Drug safety systemic risk is not found in time，or the hidden dangers of drug safety in the supervision and management area in a timely manner，Caused a serious impact;
(4) Others do not perform their duties of drug supervision and management，Caused serious adverse effects or major losses。
Chapter 6 Attachment Jeebu
Article 73 The deadline stipulated stake betting appin these stake online sports bettingMeasures is calculated by working days。Technical review and evaluation in drug production license、On -site inspection、The time required for corporate rectification is not included in the period。
Article 74 venue management file，refers to an overview document for pharmaceutical production activities written by drug manufacturers，It is part of the quality management file system of a pharmaceutical manufacturer。The relevant requirements of the venue management documents will be formulated separately。
APIs approved or related to the review and approval、Accessories and container production venues that are directly exposed to drugs、Overseas production venues will be given unified coding。
Article 75 Warning letter，refers to the drug supervision and management department in the drug supervision and management activity，For evidence to prove that there may be hidden dangers of safety hazards，Letter sent by law。The warning letter should be stated that there are defects、Questions and rectification requirements。
Article 76 Drug production license number format is "Provincial abbreviation+four years+four -bit sequence numbers"。Corporate change names and other license items, and re -issuing cards，Original drug production license number is unchanged。
Enterprise separation，While retaining the original drug production license number，Add a new number。Corporate merger，Original pharmaceutical production license number reserves one。
Article 77 Classification code is an English letter string that classifies the scope of production in the license。Capital letters for category of drug listing permit holders and product types，Including: A represents a self -produced drug listing license holder、B represents the drug listing license holder entrusted to produce、C represents a pharmaceutical manufacturer that accepts commissioned、D stands for the material drug production enterprise;，H represents chemical medicine、Z represents Chinese medicine、s represents biological products、D represents the in vitro diagnostic reagent according to the drug、Y represents Chinese medicine drinks、Q represents medical gas、T represents special medicines、x represents other。
Article 70 The production scope of the drug production license shall be filled in in accordance with the requirements of the "Pharmacopoeia of the People's Republic of China" and other national drug standards。
Article 79 National Law、Regulations for production vaccine、Blood Products、Anesthesiologist、Psychiatric drugs、Medical toxic drugs、Radioxids、Pharmaceutical Easy toxic chemicals, etc.，According to its regulations。
Article 80 The vaccine exported should meet the standards or contract requirements of imported countries (regions)。
Article 81 This method will be implemented from July 1, 2020。On August 5, 2004, the "Measures for the Supervision and Management of Drug Production Supervision" announced by the former State Food and Drug Administration was abolished at the same time。
