Chapter I General Provisions
Article 1 These Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law), the Traditional Chinese Medicine Law of the People's Republic of China, the Vaccine Administration Law of the People's Republic of China (hereinafter referred to as the Vaccine Administration Law), the Administrative Licensing Law of the People's Republic of China, the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China and other laws and administrative regulations in order to strengthen the supervision and management of drug production and standardize drug production activities.
Article 2 The production and supervision and management activities of drugs marketed in the territory of the People's Republic of China shall comply with these Measures.
Article 3 When engaging in drug production activities, laws, regulations, rules, standards and specifications shall be observed to ensure that the information of the whole process is true, accurate, complete and traceable.
When engaging in drug production activities, the drug production license shall be obtained in accordance with the law with the approval of the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the drug is located, and the drug production license shall be obtained in accordance with the law, and the drug production quality management specifications shall be strictly observed to ensure that the production process continues to meet the statutory requirements.
The holder of the drug marketing authorization shall establish a drug quality assurance system, perform the responsibility of drug marketing release, and be responsible for the quality of the drugs for which it has obtained the drug registration certificate.
Chinese herbal medicine slice production enterprises shall fulfill the relevant obligations of drug marketing authorization holders and ensure that the production process of Chinese herbal medicine slices continues to meet the statutory requirements.
API production enterprises shall organize production in accordance with the approved production process, strictly abide by the drug production quality management specifications, and ensure that the production process continues to meet the statutory requirements.
Production enterprises of excipients, packaging materials and containers that directly contact drugs that have been reviewed by the association, and other units and individuals engaged in drug-related production activities shall bear corresponding responsibilities in accordance with the law.
Article 4 Drug marketing authorization holders and drug manufacturers shall establish and implement a drug traceability system, assign traceability marks to drug sales packaging units at all levels in accordance with regulations, implement drug traceability through information technology, record and save drug traceability data in a timely and accurate manner, and provide traceability information to the drug traceability collaborative service platform.
Article 5 The State Drug Administration is responsible for the supervision and management of drug production nationwide, and supervises and guides the drug production supervision and management work of drug supervision and management departments of provinces, autonomous regions, and municipalities directly under the Central Government.
The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for the supervision and administration of drug production within their administrative regions, and undertake the work of licensing, inspection and punishment of drug production links.
The Food and Drug Review and Inspection Center of the State Drug Administration (hereinafter referred to as the Inspection Center) organizes the formulation of technical specifications and documents for drug inspections, undertakes overseas inspections and organizes vaccine inspections, analyzes and evaluates risks found in inspections, makes inspection conclusions and puts forward disposal suggestions, and is responsible for the guidance and evaluation of the quality management system of drug inspection institutions in provinces, autonomous regions and municipalities directly under the Central Government.
The Information Center of the State Drug Administration is responsible for the construction and management of the drug traceability collaborative service platform and drug safety credit files, and uniformly codes drug production sites.
The professional and technical institutions such as drug review, inspection, verification, monitoring and evaluation established or designated by the drug supervision and administration department in accordance with the law shall undertake relevant technical work and issue technical conclusions in accordance with their duties, and provide technical support for drug production supervision and administration.
Chapter II Production License
Article 6 To engage in drug production, the following conditions shall be met:
(I) There shall be pharmaceutical technicians, engineering technicians and corresponding technical workers who have been certified according to law, and the legal representative, enterprise head, production management person in charge (hereinafter referred to as production person in charge), quality management person in charge (hereinafter referred to as quality person in charge), quality authorized person and other relevant personnel shall meet the conditions stipulated in the "Drug Administration Law" and "Vaccine Administration Law";
(II) There shall be factory buildings, facilities, equipment and sanitary environment suitable for drug production;
(III) There shall be institutions and personnel capable of quality management and quality inspection of the drugs produced;
(IV) There shall be necessary instruments and equipment capable of quality management and quality inspection of the drugs produced;
(V) There shall be rules and regulations to ensure drug quality and meet the requirements of drug production quality management specifications.
Those engaged in vaccine production activities shall also meet the following conditions:
(I) There shall be a moderate scale and sufficient production capacity reserves;
(II) There shall be systems, facilities and equipment to ensure biosafety;
(III) It shall meet the needs of disease prevention and control.
Article 7 Applicants engaged in the production of preparations, APIs, and Chinese herbal medicine slices shall apply to the drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where they are located in accordance with the requirements for application materials stipulated in these Measures and the State Drug Administration.
Drug marketing authorization holders who entrust others to produce preparations shall meet the conditions stipulated in the first, third, and fifth items of the first paragraph of Article 6 of these Measures, and sign a commission agreement and quality agreement with a qualified drug manufacturer, and submit the relevant agreements and application materials for the actual production site to the drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where the drug marketing authorization holder is located, and apply for a drug production license in accordance with the provisions of these Measures.
Applicants shall be responsible for the authenticity of all the contents of their application materials.
Article 8 Upon receiving an application, the drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall make a decision according to the following circumstances:
(I) If the application does not fall within the scope of the department’s authority according to law, the department shall immediately make a decision not to accept the application and inform the applicant to apply to the relevant administrative authority;
(II) If the application does not require an administrative license according to law, the applicant shall be immediately informed that the application will not be accepted;
(III) If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot;
(IV) If the application materials are incomplete or do not meet the requirements of formal examination, the applicant shall be issued a notice of supplementary materials on the spot or within five days, informing the applicant of all the contents that need to be supplemented at one time. If the applicant is not informed within the time limit, the application shall be deemed to be accepted from the date of receipt of the application materials;
(V) If the application materials are complete and meet the requirements of formal examination, or the applicant submits all the supplementary materials as required, the application shall be accepted.
When a drug regulatory department of a province, autonomous region or municipality directly under the Central Government accepts or rejects an application for a drug production license, it shall issue an acceptance notice or a rejection notice with the department’s special seal and date.
Article 9 The drug regulatory authorities of provinces, autonomous regions and municipalities directly under the Central Government shall make a decision within 30 days from the date of acceptance.
If the application meets the requirements after review, it shall be approved and a drug production license shall be issued within 10 days from the date of written approval; if it does not meet the requirements, a written decision of disapproval shall be made with reasons.
The drug regulatory authorities of provinces, autonomous regions and municipalities directly under the Central Government shall organize technical review and evaluation of application materials and on-site inspection in accordance with relevant provisions such as the Good Manufacturing Practice for Pharmaceuticals.
Article 10 The drug regulatory authorities of provinces, autonomous regions and municipalities directly under the Central Government shall publicize the conditions, procedures, deadlines, catalogs of all materials to be submitted and sample application forms required for applying for drug production licenses on the websites and offices of administrative agencies.
The relevant information on drug production licenses issued by drug regulatory authorities of provinces, autonomous regions and municipalities directly under the Central Government shall be made public and the public shall have the right to review it.
Article 11 When reviewing applications for drug production licenses, drug regulatory authorities of provinces, autonomous regions and municipalities directly under the Central Government shall make public the approval results and provide conditions for applicants to inquire about the approval process.
Without the consent of the applicant, the drug supervision and administration department, professional and technical institutions and their staff shall not disclose the business secrets, undisclosed information or confidential business information submitted by the applicant, except as otherwise provided by law or involving national security or major social public interests.
Article 12 Where the application for a drug production license directly involves a major interest relationship between the applicant and others, the applicant and the interested party shall have the right to apply for a hearing in accordance with the provisions of laws and regulations.
When reviewing the application of a drug manufacturer, the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government shall announce it to the public and hold a hearing if it believes that it involves public interests.
Article 13 The validity period of a drug production license is five years, and it is divided into an original and a copy. The format of the drug production license shall be uniformly formulated by the State Drug Administration. The electronic certificate of the drug production license has the same legal effect as the paper certificate.
Article 14 The drug production license shall state the license number, classification code, enterprise name, unified social credit code, residence (business premises), legal representative, enterprise head, production head, quality head, quality authorized person, production address and production scope, issuing authority, issuance date, validity period and other items.
Enterprise name, unified social credit code, domicile (business premises), legal representative and other items shall be consistent with the relevant contents stated in the business license issued by the market supervision and management department.
Article 15 The matters stated in the drug production license are divided into permitted matters and registered matters.
Permitted matters refer to the production address and production scope, etc.
Registered matters refer to the enterprise name, domicile (business premises), legal representative, enterprise head, production head, quality head, quality authorized person, etc.
Article 16 If the permitted matters of the drug production license are changed, an application for change of the drug production license shall be submitted to the original issuing authority. Without approval, the permitted matters shall not be changed without authorization.
The original issuing authority shall make a decision on whether to approve the change within 15 days from the date of receipt of the enterprise's change application. If the change is not approved, the reasons shall be stated in writing and the applicant shall be informed of the right to apply for administrative reconsideration or initiate administrative litigation in accordance with the law.
When changing the production address or production scope, the drug manufacturer shall submit relevant materials related to the change in accordance with the provisions of Article 6 of these Measures and relevant technical requirements for changes, and report to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government for review and decision.
When a new workshop or production line is built, rebuilt or expanded at the original site or in a different location, it shall comply with relevant regulations and technical requirements, submit relevant materials related to the change, and report to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government for compliance inspection of drug production quality management regulations, and the inspection results shall be notified to the enterprise. If the inspection results comply with the regulations and the product meets the release requirements, it can be put on the market for sale. The relevant changes shall be stated in the copy of the drug production license.
If the above-mentioned changes involve the contents of the drug registration certificate and its annexes, the drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall approve it and report to the Drug Review Center of the State Drug Administration to update the relevant contents of the drug registration certificate and its annexes.
Article 17 If the registration items of the drug production license are changed, the original issuing authority shall apply for the change registration of the drug production license within 30 days after the market supervision and administration department approves the change or the enterprise completes the change. The original issuing authority shall handle the change formalities within ten days from the date of receipt of the enterprise's change application.
Article 18 After the drug production license is changed, the original issuing authority shall record the content and time of the change on the copy of the drug production license, and reissue the original drug production license according to the changed content, and take back the original drug production license. The expiration date of the changed drug production license remains unchanged.
Article 19 If the drug production license expires and it is necessary to continue to produce drugs, it shall apply to the original issuing authority for reissuance of the drug production license six months before the expiration of the validity period.
The original issuing authority shall review the enterprise's compliance with drug management laws and regulations, drug production quality management standards and quality system operation according to the principle of risk management, and make a decision on whether to grant it a reissue of the license before the expiration of the drug production license. If the reissue is approved in accordance with the regulations, the original license shall be taken back and a new license shall be issued; if it is not in accordance with the regulations, a written decision not to reissue the license shall be made, and the reasons shall be stated, and the applicant shall be informed that he has the right to apply for administrative reconsideration or initiate administrative litigation in accordance with the law; if no decision is made within the time limit, it shall be deemed to agree to reissue the license and the corresponding procedures shall be completed.
Article 20 If any of the following circumstances occurs, the drug production license shall be cancelled by the original issuing authority and announced:
(i) Actively apply for cancellation of the drug production license;
(ii) The drug production license expires and is not reissued;
(iii) The business license is revoked or cancelled according to law;
(iv) The drug production license is revoked or cancelled according to law;
(v) Other circumstances where laws and regulations stipulate that the administrative license should be cancelled.
Article 21 If the drug production license is lost, the drug marketing license holder and the drug manufacturer shall apply to the original issuing authority for reissue, and the original issuing authority shall reissue the drug production license within ten days in accordance with the original approval matters. The license number, validity period, etc. are consistent with the original license.
Article 22 No unit or individual may forge, alter, rent, lend, or buy and sell drug production licenses.
Article 23 The drug regulatory authorities of provinces, autonomous regions and municipalities directly under the Central Government shall update the issuance, re-issuance, change, reissue, revocation, cancellation and other handling of drug production licenses in the drug safety credit file within ten days after the handling work is completed.
Chapter III Production Management
Article 24 Those engaged in drug production activities shall comply with the drug production quality management specifications, produce in accordance with national drug standards, drug registration standards and production processes approved by the drug regulatory authorities, submit and continuously update site management documents in accordance with regulations, conduct risk assessment and continuous improvement of the quality system operation process, and ensure that the entire drug production process continues to meet legal requirements. Production, inspection and other records shall be complete and accurate, and shall not be fabricated or tampered with.
Article 25 The holder of a vaccine marketing license shall have the necessary factory facilities and equipment for vaccine production and inspection, be equipped with qualified management personnel, establish a sound quality management system, and have the ability to produce vaccines that meet registration requirements. If the vaccine production capacity exceeds the production capacity and it is indeed necessary to entrust the production, it shall be approved by the State Drug Administration.
Article 26 Those engaged in drug production activities shall comply with the drug production quality management regulations, establish and improve the drug production quality management system, cover all factors affecting drug quality, and ensure that the entire drug production process continues to meet legal requirements.
Article 27 The drug marketing authorization holder shall establish a drug quality assurance system, assign special personnel to be independently responsible for drug quality management, conduct regular audits of the quality management systems of entrusted drug manufacturers and drug dealers, and supervise their continued quality assurance and control capabilities.
Article 28 The legal representative and principal person in charge of the drug marketing authorization holder shall be fully responsible for drug quality and perform the following duties:
(I) Assign a special quality person in charge to be independently responsible for drug quality management;
(II) Assign a special quality authorized person to independently perform the responsibility of drug marketing release;
(III) Supervise the normal operation of the quality management system;
(IV) Regularly supervise the activities of drug manufacturers, suppliers and other relevant parties related to drug production
Conduct quality system audits regularly to ensure continuous compliance;
(V) Perform change management responsibilities in accordance with the technical requirements of the change;
(VI) Conduct quality assessments on the entrusted operating enterprises and communicate information with the user units, etc.;
(VII) Cooperate with the drug supervision and administration department to conduct extended inspections on drug marketing authorization holders and related parties;
(VIII) In the event of major safety incidents related to drug quality, they should be reported in a timely manner and risk disposal should be carried out in accordance with the risk management plan formulated by the holder to ensure that risks are controlled in a timely manner;
(IX) Other responsibilities prescribed by laws and regulations.
Article 29 The legal representative and principal person in charge of a pharmaceutical production enterprise shall be fully responsible for the pharmaceutical production activities of the enterprise and perform the following duties:
(I) Appoint a special quality person in charge to be independently responsible for pharmaceutical quality management, supervise the implementation of quality management specifications, ensure appropriate production process control and quality control, and ensure that the drugs comply with national drug standards and drug registration standards;
(II) Appoint a special quality authorized person to perform the responsibility of releasing drugs from the factory;
(III) Supervise the normal operation of the quality management system, ensure the authenticity of pharmaceutical production process control, quality control, and records and data;
(IV) In the event of a major safety incident related to drug quality, it shall be reported in a timely manner and risk disposal shall be carried out in accordance with the risk management plan formulated by the enterprise to ensure that the risk is controlled in a timely manner;
(V) Other responsibilities prescribed by laws and regulations.
Article 30 The drug marketing authorization holder and the drug production enterprise shall conduct health examinations and establish health records for the staff who directly contact the drugs every year to avoid personnel with infectious diseases or other diseases that may contaminate the drugs from engaging in production activities that directly contact the drugs.
Article 31: In drug production, drug marketing authorization holders and drug manufacturers shall carry out quality management activities such as risk assessment, control, verification, communication, and review, and take effective risk control measures for identified risks in a timely manner to ensure product quality.
Article 32: When engaging in drug production activities, suppliers or manufacturers of related materials such as raw materials, excipients, packaging materials and containers that directly contact drugs, etc. shall be reviewed to ensure that the purchase and use comply with regulatory requirements.
The raw materials and excipients required for the production of drugs shall comply with the requirements of pharmaceutical use and the relevant requirements of the corresponding production quality management specifications. The packaging materials and containers that directly contact drugs shall comply with the requirements of pharmaceutical use and meet the standards for protecting human health and safety.
Article 33: Manufacturers of raw materials, excipients, packaging materials and containers that directly contact drugs that have been approved or passed the related review and approval shall comply with the quality management specifications formulated by the State Drug Administration and the related requirements of the related review and approval, ensure the continuous compliance of the quality assurance system, accept the quality review of the drug marketing authorization holder, and accept the supervision and inspection or extended inspection of the drug supervision and administration department.
Article 34 Pharmaceutical manufacturers shall determine the confirmation and validation required and implement them according to the confirmation and validation plan. Regularly evaluate facilities, equipment, production processes and cleaning methods to confirm that they continue to maintain the validation status.
Article 35 Pharmaceutical manufacturers shall take control measures to prevent contamination, cross-contamination, confusion and errors, and regularly check and evaluate the applicability and effectiveness of control measures to ensure that drugs meet the prescribed national drug standards and drug registration standards and comply with the requirements of drug production quality management regulations.
Drug marketing authorization holders and drug manufacturers shall not produce other products that have an adverse effect on drug quality in drug production plants.
Article 36 Drug packaging operations shall take measures to reduce the risk of confusion and errors, and drug packaging shall ensure that drugs within the validity period are not contaminated during storage and transportation.
The statements in drug instructions and labels shall be scientific, standardized and accurate, and the text shall be clear and legible. They shall not be modified or supplemented by pasting, cutting, alteration, etc.
Article 37 Drug manufacturers shall establish procedures for drug release, clarify the standards and conditions for drug release, and review the drug quality inspection results, key production records and deviation control, and conduct quality inspection on drugs. If the standards and conditions are met, they can be released from the factory only after the signature of the quality authorized person.
Drug marketing authorization holders shall establish drug release procedures, review the drug inspection results and release documents released from the factory by drug manufacturers, and release them on the market only after the signature of the quality authorized person.
Chinese herbal medicines can only be shipped and sold if they meet the national drug standards or the processing specifications formulated by the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the central government.
Article 38 Drug marketing authorization holders and drug manufacturers shall conduct self-inspections every year, monitor the implementation of drug production quality management specifications, evaluate whether the enterprises meet the requirements of relevant laws and regulations, and propose necessary corrective and preventive measures.
Article 39 The holder of a drug marketing authorization shall establish an annual reporting system and report the drug production and sales, post-marketing research, risk management, etc. to the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government in accordance with the provisions of the State Drug Administration.
The holder of a vaccine marketing authorization shall submit an annual report to the State Drug Administration in accordance with the regulations.
Article 40 The holder of a drug marketing authorization shall continuously carry out drug risk-benefit assessment and control, formulate a post-marketing drug risk management plan, actively carry out post-marketing research, further confirm the safety, effectiveness and quality controllability of drugs, and strengthen the continuous management of marketed drugs.
Article 41 The holder of a drug marketing authorization shall establish a drug vigilance system and carry out drug vigilance work in accordance with the drug vigilance quality management specifications formulated by the State Drug Administration.
The holder of a drug marketing authorization and drug manufacturers shall regularly inspect the drug quality, efficacy and adverse reactions of their units. If suspected adverse reactions are found, they shall be reported in a timely manner as required.
Article 42 The holder of a drug marketing authorization shall entrust the production of drugs in accordance with the relevant provisions of drug management.
If the drug marketing authorization holder entrusts a qualified drug manufacturer to produce drugs, it shall evaluate the quality assurance and risk management capabilities of the entrustee, sign a quality agreement and entrustment agreement with it in accordance with the requirements of the quality agreement guide for drug entrustment production formulated by the State Drug Administration, and supervise the entrustee to fulfill the obligations agreed in the relevant agreement.
The entrustee shall not entrust the production of drugs entrusted to a third party again.
The APIs approved or approved by the related review and approval shall be produced by themselves and shall not be entrusted to others for production.
Article 43 The drug marketing authorization holder shall manage and control the production process changes in accordance with the requirements of the drug production quality management regulations, and formulate process regulations based on the approved production process. The production process changes shall be studied, and approval, filing or reporting shall be obtained in accordance with the law, and supervision and inspection by the drug supervision and administration department shall be accepted.
Article 44 The drug marketing authorization holder and drug manufacturer shall conduct product quality review, analysis and record of the drugs produced according to the variety every year to confirm the stability and reliability of the process and the applicability of the current quality standards of raw materials, excipients and finished products.
Article 45 If there is any change in the organization, enterprise leader, production manager, quality manager, quality authorized person related to the quality management system of the drug marketing authorization holder or drug manufacturer, the registration procedures shall be completed within 30 days from the date of the change.
The vaccine marketing authorization holder shall report the changes in the key personnel such as production manager, quality manager, quality authorized person, etc. to the drug supervision and administration department of the province, autonomous region or municipality directly under the central government where it is located within 15 days from the date of the change.
Article 46 If the drug marketing authorization holder stops the production of drugs included in the list of short supply drugs for which the state implements production suspension report, it shall report to the drug supervision and administration department of the province, autonomous region or municipality directly under the central government where it is located six months before the planned suspension of production; if an unexpected suspension of production occurs, it shall report to the drug supervision and administration department of the province, autonomous region or municipality directly under the central government where it is located within three days. If necessary, report to the State Drug Administration.
After receiving the report, the drug supervision and administration department shall promptly inform the leading unit of the consultation and linkage mechanism for the supply guarantee of short supply drugs at the same level.
Article 47 If the drug marketing authorization holder is a foreign enterprise, it shall designate a corporate legal person in China to perform the obligations of the drug marketing authorization holder stipulated in the Drug Administration Law and these Measures, and be responsible for coordinating and cooperating with overseas inspections.
Article 48 If the drug marketing authorization holder's production site is located abroad, it shall organize production in accordance with the Drug Administration Law and these Measures and cooperate with overseas inspections.
Specific news link: Newly revised "Drug Production Supervision and Management Measures"
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