Measures for the Supervision and Administration of Drug Production
Measures for the Supervision and Administration of Drug Production
Measures for the Supervision and Administration of Drug Production
Order of the State Administration for Market Regulation No.28
January 22, 2020
The Measures for the Supervision and Administration of Drug Production, which were deliberated and adopted at the First Executive Meeting in 2020 of the State Administration for Market Regulation on January 15, 2020, are hereby promulgated and shall come into force as of July 1, 2020.
Xiao Yaqing, Director
Measures for the Supervision and Administration of Drug Production
(Promulgated as Order of the State Administration for Market Regulation No.28 on January 22, 2020)
Chapter I General Provisions
Article 1 In order to strengthen the supervision and administration of drug production and regulate drug production activities, 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 Law of the People's Republic of China on Traditional Chinese Medicine, 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 Implementing Regulations on the Drug Administration Law of the People's Republic of China and other laws and administrative regulations.
Article 2 Activities of production, supervision and administration of drugs marketed within the territory of the People's Republic of China shall be conducted in compliance with these Measures.
Article 3 Those which engage in drug production activities shall comply with laws, regulations, rules, standards and specifications and ensure the authenticity, accuracy, completeness and traceability of their information in the whole process.
Those which are to engage in drug production activities shall be subject to approval from the medical products administrations of the provinces, autonomous regions and municipalities directly under the Central Government where they are located, obtain a drug production license in accordance with the law, strictly comply with the Good Manufacturing Practices (GMP), and ensure that their production processes continuously meet the statutory requirements.
Marketing authorization holders (MAHs) shall establish a drug quality assurance system, fulfill responsibility for the release of drug marketing and assume responsibility for the quality of the drugs for which they have obtained a drug registration certificate.
Enterprises that produce traditional Chinese medicine (TCM) decoction pieces shall fulfill their relevant obligations as MAHs and ensure that their production processes continuously meet the statutory requirements.
Enterprises that produce active pharmaceutical ingredients (APIs) shall organize their production in accordance with the approved production processes, strictly comply with the GMP, and ensure that their production processes continuously meet the statutory requirements.
Enterprises that produce pharmaceutical excipients, packaging materials and containers in direct contact with drugs, all of which have passed the bundling review, as well as other entities and individuals which engage in drug-related production activities shall assume corresponding responsibilities in accordance with the law.
Article 4 MAHs and drug producers shall establish and implement a drug traceability system, apply traceability marks to drug sales and packaging units at all levels in accordance with provisions, carry out drug tracing through informatization means, promptly and accurately record and save drug traceability data, and provide traceability information for the drug traceability collaborative service platform.
Article 5 The National Medical Products Administration shall take charge of the supervision and administration of drug production in the whole country, and supervise and guide the drug production supervision and administration work of medical products administrations of provinces, autonomous regions and municipalities directly under the Central Government.
Medical products administrations of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the supervision and administration of the drug production within their respective administrative regions, and undertake licensing, inspection, penalization and other work in the drug production link.
The Center for Food and Drug Inspection of the National Medical Products Administration (hereinafter referred to as the "CFDI") shall organize the formulation of technical specifications and documents on drug inspection, undertake overseas inspections, organize vaccine patrol inspections, analyze and evaluate risks found during inspections, draw inspection conclusions and put forward handling suggestions, and shall assume responsibility for the guidance and evaluation of the quality management systems of drug inspection institutions in all provinces, autonomous regions and municipalities directly under the Central Government.
The Center for Information of the National Medical Products Administration shall be responsible for the establishment and management of the drug traceability collaborative service platform and drug safety credit archives, and carry out unified coding of drug production sites.
Professional technical institutions for drug review, inspection, verification, monitoring, evaluation, etc. which are set up or designated by medical products administrations in accordance with the law shall undertake relevant technical work and issue technical conclusions in accordance with their responsibilities and provide technical support for the supervision and administration of drug production.
Chapter II Production Licensing
Article 6 Those which engage in drug production shall meet the following requirements:
1. have legally qualified pharmaceutical technicians, engineering technicians and corresponding technical workers, as well as a legal representative, a person in charge of the enterprise, a person in charge of production management (hereinafter referred to as the "Person in Charge of Production"), a person in charge of quality management (hereinafter referred to as the "Person in Charge of Quality"), a qualified person and other relevant personnel who meet the requirements of the Drug Administration Law and the Vaccine Administration Law;
2. have workshops, facilities, equipment and a sanitary environment suitable for drug production;
3. have institutions and personnel capable of quality management and inspection of the drugs produced;
4. have the necessary instruments and equipment capable of quality management and inspection of the drugs produced; and
5. have rules and regulations which can ensure the quality of drugs and meet the requirements of the GMP.
Those which engage in vaccine production activities shall also meet the following requirements:
1. have an appropriate scale and sufficient production capacity reserve;
2. have systems, facilities and equipment that can ensure biosafety; and
3. meet the needs of disease prevention and control.
Article 7 To engage in the production of preparations, APIs and TCM decoction pieces, the applicant shall, in accordance with these Measures and the requirements stipulated by the National Medical Products Administration on application materials, summit an application to the medical products administration of the province, autonomous region or municipality directly under the Central Government where the applicant is located.
An MAH who entrusts another party to produce preparations shall meet the requirements as specified in Items 1, 3 and 5, Paragraph 1 of Article 6 hereof, sign an entrustment agreement and a quality agreement with a qualified drug producer, and submit the relevant agreements and the application materials of the actual production site to the medical products administration of the province, autonomous region or municipality directly under the Central Government where the MAH is located to apply for the drug production license in accordance with the provisions of these Measures.
The applicant shall be responsible for the authenticity of all the contents of its application materials.
Article 8 Upon receipt of an application, the medical products administration of the relevant province, autonomous region or municipality directly under the Central Government shall handle the application respectively according to the following circumstances:
1. if the matter under application does not fall within the scope of its own functions and powers in accordance with the law, it shall immediately make a decision not to accept the application and inform the applicant to apply to the relevant administrative organ instead;
2. if no administrative licensing is required for the matter under application in accordance with the law, it shall immediately inform the applicant that the application will not be accepted;
3. if there are errors in the application materials that can be corrected on the spot, it shall allow the applicant to do so on the spot;
4. if the application materials are not complete or do not conform to the requirements of formal examination, it shall issue a notice for supplementation/correction of materials to the applicant on the spot or within five days and give a one-time notification to the applicant of all the contents that need to be supplemented/corrected. Failure to give such notification within the specified time limit shall be deemed as having accepted the application as of the date of receipt of the application materials; or
5. if the application materials are complete and conform to the requirements of formal examination, or the applicant has submitted all the supplementary/corrective materials as required, it shall accept the application.
If the medical products administration of the relevant province, autonomous region or municipality directly under the Central Government accepts or refuses to accept the application for a drug production license, it shall issue a notice of acceptance or a notice of rejection with its special seal affixed and the date indicated.
Article 9 The medical products administration of a province, autonomous region or municipality directly under the Central Government shall make a decision within 30 days from the date of acceptance.
If the application meets the provisions upon examination, the medical products administration of the relevant province, autonomous region or municipality directly under the Central Government shall approve it and issue a drug production license within ten days from the date of making of the written decision of approval; if it does not meet the provisions, a written decision of no approval shall be made, with the reasons therefor stated.
The medical products administration of the relevant province, autonomous region or municipality directly under the Central Government shall organize the technical examination, evaluation and on-site inspection of the application materials in accordance with the relevant provisions of the GMP and so on.
Article 10 Medical products administrations of provinces, autonomous regions and municipalities directly under the Central Government shall publicize on the websites and office premises of the administrative organs the requirements, procedures, time limit, catalog of all materials to be submitted and model text of the application, etc. which are needed when applying for a drug production license.
The relevant information on the issuance of drug production licenses by medical products administrations of provinces, autonomous regions and municipalities directly under the Central Government shall be made public, and the public shall have the right to consult it.
Article 11 When medical products administrations of provinces, autonomous regions and municipalities directly under the Central Government examine applications for drug production licenses, they shall make the results of their examination and approval public and provide facilities to facilitate applicants to inquire about the examination and approval process.
Without the consent of an applicant, no medical products administration, professional technical institution or their staff may disclose the trade secrets, undisclosed information or confidential business information submitted by the applicant, unless otherwise provided for by law or where national security or major social public interests are involved.
Article 12 Where an application for the drug production license directly involves a major relationship of interest between the applicant and others, the applicant and the interested parties shall have the right to apply for a hearing in accordance with the provisions of laws and regulations.
When examining an application from a drug producer, if the medical products administration of the relevant province, autonomous region or municipality directly under the Central Government deems that the said application involves public interests, it shall make an announcement to the public and hold a hearing.
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Order of the State Administration for Market Regulation No.28
January 22, 2020
The Measures for the Supervision and Administration of Drug Production, which were deliberated and adopted at the First Executive Meeting in 2020 of the State Administration for Market Regulation on January 15, 2020, are hereby promulgated and shall come into force as of July 1, 2020.
Xiao Yaqing, Director
Measures for the Supervision and Administration of Drug Production
(Promulgated as Order of the State Administration for Market Regulation No.28 on January 22, 2020)
Chapter I General Provisions
Article 1 In order to strengthen the supervision and administration of drug production and regulate drug production activities, 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 Law of the People's Republic of China on Traditional Chinese Medicine, 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 Implementing Regulations on the Drug Administration Law of the People's Republic of China and other laws and administrative regulations.
Article 2 Activities of production, supervision and administration of drugs marketed within the territory of the People's Republic of China shall be conducted in compliance with these Measures.
Article 3 Those which engage in drug production activities shall comply with laws, regulations, rules, standards and specifications and ensure the authenticity, accuracy, completeness and traceability of their information in the whole process.
Those which are to engage in drug production activities shall be subject to approval from the medical products administrations of the provinces, autonomous regions and municipalities directly under the Central Government where they are located, obtain a drug production license in accordance with the law, strictly comply with the Good Manufacturing Practices (GMP), and ensure that their production processes continuously meet the statutory requirements.
Marketing authorization holders (MAHs) shall establish a drug quality assurance system, fulfill responsibility for the release of drug marketing and assume responsibility for the quality of the drugs for which they have obtained a drug registration certificate.
Enterprises that produce traditional Chinese medicine (TCM) decoction pieces shall fulfill their relevant obligations as MAHs and ensure that their production processes continuously meet the statutory requirements.
Enterprises that produce active pharmaceutical ingredients (APIs) shall organize their production in accordance with the approved production processes, strictly comply with the GMP, and ensure that their production processes continuously meet the statutory requirements.
Enterprises that produce pharmaceutical excipients, packaging materials and containers in direct contact with drugs, all of which have passed the bundling review, as well as other entities and individuals which engage in drug-related production activities shall assume corresponding responsibilities in accordance with the law.
Article 4 MAHs and drug producers shall establish and implement a drug traceability system, apply traceability marks to drug sales and packaging units at all levels in accordance with provisions, carry out drug tracing through informatization means, promptly and accurately record and save drug traceability data, and provide traceability information for the drug traceability collaborative service platform.
Article 5 The National Medical Products Administration shall take charge of the supervision and administration of drug production in the whole country, and supervise and guide the drug production supervision and administration work of medical products administrations of provinces, autonomous regions and municipalities directly under the Central Government.
Medical products administrations of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the supervision and administration of the drug production within their respective administrative regions, and undertake licensing, inspection, penalization and other work in the drug production link.
The Center for Food and Drug Inspection of the National Medical Products Administration (hereinafter referred to as the "CFDI") shall organize the formulation of technical specifications and documents on drug inspection, undertake overseas inspections, organize vaccine patrol inspections, analyze and evaluate risks found during inspections, draw inspection conclusions and put forward handling suggestions, and shall assume responsibility for the guidance and evaluation of the quality management systems of drug inspection institutions in all provinces, autonomous regions and municipalities directly under the Central Government.
The Center for Information of the National Medical Products Administration shall be responsible for the establishment and management of the drug traceability collaborative service platform and drug safety credit archives, and carry out unified coding of drug production sites.
Professional technical institutions for drug review, inspection, verification, monitoring, evaluation, etc. which are set up or designated by medical products administrations in accordance with the law shall undertake relevant technical work and issue technical conclusions in accordance with their responsibilities and provide technical support for the supervision and administration of drug production.
Chapter II Production Licensing
Article 6 Those which engage in drug production shall meet the following requirements:
1. have legally qualified pharmaceutical technicians, engineering technicians and corresponding technical workers, as well as a legal representative, a person in charge of the enterprise, a person in charge of production management (hereinafter referred to as the "Person in Charge of Production"), a person in charge of quality management (hereinafter referred to as the "Person in Charge of Quality"), a qualified person and other relevant personnel who meet the requirements of the Drug Administration Law and the Vaccine Administration Law;
2. have workshops, facilities, equipment and a sanitary environment suitable for drug production;
3. have institutions and personnel capable of quality management and inspection of the drugs produced;
4. have the necessary instruments and equipment capable of quality management and inspection of the drugs produced; and
5. have rules and regulations which can ensure the quality of drugs and meet the requirements of the GMP.
Those which engage in vaccine production activities shall also meet the following requirements:
1. have an appropriate scale and sufficient production capacity reserve;
2. have systems, facilities and equipment that can ensure biosafety; and
3. meet the needs of disease prevention and control.
Article 7 To engage in the production of preparations, APIs and TCM decoction pieces, the applicant shall, in accordance with these Measures and the requirements stipulated by the National Medical Products Administration on application materials, summit an application to the medical products administration of the province, autonomous region or municipality directly under the Central Government where the applicant is located.
An MAH who entrusts another party to produce preparations shall meet the requirements as specified in Items 1, 3 and 5, Paragraph 1 of Article 6 hereof, sign an entrustment agreement and a quality agreement with a qualified drug producer, and submit the relevant agreements and the application materials of the actual production site to the medical products administration of the province, autonomous region or municipality directly under the Central Government where the MAH is located to apply for the drug production license in accordance with the provisions of these Measures.
The applicant shall be responsible for the authenticity of all the contents of its application materials.
Article 8 Upon receipt of an application, the medical products administration of the relevant province, autonomous region or municipality directly under the Central Government shall handle the application respectively according to the following circumstances:
1. if the matter under application does not fall within the scope of its own functions and powers in accordance with the law, it shall immediately make a decision not to accept the application and inform the applicant to apply to the relevant administrative organ instead;
2. if no administrative licensing is required for the matter under application in accordance with the law, it shall immediately inform the applicant that the application will not be accepted;
3. if there are errors in the application materials that can be corrected on the spot, it shall allow the applicant to do so on the spot;
4. if the application materials are not complete or do not conform to the requirements of formal examination, it shall issue a notice for supplementation/correction of materials to the applicant on the spot or within five days and give a one-time notification to the applicant of all the contents that need to be supplemented/corrected. Failure to give such notification within the specified time limit shall be deemed as having accepted the application as of the date of receipt of the application materials; or
5. if the application materials are complete and conform to the requirements of formal examination, or the applicant has submitted all the supplementary/corrective materials as required, it shall accept the application.
If the medical products administration of the relevant province, autonomous region or municipality directly under the Central Government accepts or refuses to accept the application for a drug production license, it shall issue a notice of acceptance or a notice of rejection with its special seal affixed and the date indicated.
Article 9 The medical products administration of a province, autonomous region or municipality directly under the Central Government shall make a decision within 30 days from the date of acceptance.
If the application meets the provisions upon examination, the medical products administration of the relevant province, autonomous region or municipality directly under the Central Government shall approve it and issue a drug production license within ten days from the date of making of the written decision of approval; if it does not meet the provisions, a written decision of no approval shall be made, with the reasons therefor stated.
The medical products administration of the relevant province, autonomous region or municipality directly under the Central Government shall organize the technical examination, evaluation and on-site inspection of the application materials in accordance with the relevant provisions of the GMP and so on.
Article 10 Medical products administrations of provinces, autonomous regions and municipalities directly under the Central Government shall publicize on the websites and office premises of the administrative organs the requirements, procedures, time limit, catalog of all materials to be submitted and model text of the application, etc. which are needed when applying for a drug production license.
The relevant information on the issuance of drug production licenses by medical products administrations of provinces, autonomous regions and municipalities directly under the Central Government shall be made public, and the public shall have the right to consult it.
Article 11 When medical products administrations of provinces, autonomous regions and municipalities directly under the Central Government examine applications for drug production licenses, they shall make the results of their examination and approval public and provide facilities to facilitate applicants to inquire about the examination and approval process.
Without the consent of an applicant, no medical products administration, professional technical institution or their staff may disclose the trade secrets, undisclosed information or confidential business information submitted by the applicant, unless otherwise provided for by law or where national security or major social public interests are involved.
Article 12 Where an application for the drug production license directly involves a major relationship of interest between the applicant and others, the applicant and the interested parties shall have the right to apply for a hearing in accordance with the provisions of laws and regulations.
When examining an application from a drug producer, if the medical products administration of the relevant province, autonomous region or municipality directly under the Central Government deems that the said application involves public interests, it shall make an announcement to the public and hold a hearing.
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