Measures for the Supervision and Administration of Pharmaceutical Production (Revised in 2017)
Measures for the Supervision and Administration of Pharmaceutical Production (Revised in 2017)
Measures for the Supervision and Administration of Pharmaceutical Production (Revised in 2017)
Order of the China Food and Drug Administration No.37
November 17, 2017
(Promulgated by the Order of the China Food and Drug Administration No.14 on August 5, 2004; and amended in accordance with the Decision of the China Food and Drug Administration on Revising Some Rules at the executive meeting of the China Food and Drug Administration on November 7, 2017)
Chapter I General Provisions
Article 1 To strengthen the supervision over and administration of pharmaceutical production, the present Measures have been formulated in accordance with the Drug Administration Law of the People's Republic of China (Pharmaceutical Administration Law) and the Implementing Regulations of the Drug Administration Law of the People's Republic of China (Regulation).
Article 2 Supervision over and administration of pharmaceutical production shall refer to activities, among other administrative activities, of food and drug administration departments that examine, license, supervise and inspect pharmaceutical production conditions and processing.
Article 3 The China Food and Drug Administration shall be responsible the nationwide supervision and administration of pharmaceutical production. The food and drug administration departments of the provinces, autonomous regions and municipalities directly under the Central Government are responsible for the supervision and administration of pharmaceutical production within their respective administrative regions.
Chapter II Application, Examination and Approval to Establish Pharmaceutical-production Enterprises
Article 4 When launching a pharmaceutical-production enterprise, the following conditions must be met, in addition to the pharmaceutical industry development plan and the State's industrial policies:
1. Have technicians, in pharmacology, engineers, technicians and corresponding technical workers whose qualifications are certified; and the legal representative, or the person responsible for the enterprise, and the person in charge of quality do not fall under any of the circumstances outlined in Article 76 of the Pharmaceutical Administration Law;
2. Have workshops, facilities and a sanitation environment suitable for pharmaceutical production;
3. Have institutions, personnel capable of quality control and inspecting the pharmaceuticals produced, and the necessary apparatuses and equipment; and
4. Have regulations to ensure the quality of the pharmaceutical products.
If relevant State laws and regulations contain different provisions on the production of narcotic pharmaceuticals; psychotropic pharmaceuticals; toxic pharmaceuticals, for medical treatments; radioactive pharmaceuticals; and/or precursor chemicals, of the pharmaceutical category, the provisions shall apply.
Article 5 An applicant who intends to launch a pharmaceutical-production enterprise shall file an application to the food and drug administration department of the province, autonomous region or municipality directly under the Central Government at his/her/its locality, and he/she/it shall submit the following documents:
1. Basic information about the applicant and pertinent certificates and relevant documents;
2. Basic conditions of the enterprise to be launched, including the name of the enterprise, types of production, type of pharmaceuticals equipment, techniques and throughput; statements about the site of the enterprise, environment around the site, and infrastructure, etc., as well as statements about the investment scale and other conditions;
3. corporate business license, productions address and registered address, type of enterprise, legal representative or the person responsible for the enterprise;
4. Organization plan for the enterprise to be launched (indicating the functions of each sector and their correlation, and the person responsible for each sector);
5. Resumes, educational backgrounds and title certificates of the legal representatives and people responsible for the enterprise to be launched, and for the people responsible for each sector of the enterprise; the registration forms for the technicians of pharmacology and relevant professionals, engineers and technicians, and technical workers, whose qualifications have been certified, with an indication of the sectors they will be in and the posts they will hold; the proportion statement of the senior, medium and preliminary technicians;
6. Map detailing the environment around the enterprise to be launched, general plane figure, storage plane figure, plane figure of quality inspection place;
7. Plan for the arrangement of production techniques of the enterprise (including dressing room, water closet, passage for stream of people and material circulation, and air brake, etc., and indicating the flow of the people and materials and the grade of air cleanliness factor), plan of the blowing, returning and ventilation of the air-cleansing system, and the plan for the arrangement of techniques and equipment;
8. The scope, type of pharmaceuticals varieties, quality standards and the basis of the pharmaceuticals to be produced;
9. The technical flow chart of the type of pharmaceuticals and varieties of pharmaceuticals to be produced, with the major quality reference points and items indicated;
10. The general situation regarding the validation of the air-cleansing system, water-treatment system and the major equipment; conditions of the checkout of the production and inspection apparatuses, instruments and weighing apparatuses;
11. Lists of major production equipment and inspection apparatuses; and
12. The contents of documents regarding production management and quality control of the enterprise to be launched.
The applicant shall be responsible for the truthfulness of all contents contained within the application documents.
Article 6 If a pharmaceutical-production enterprise divides part of its production workshops and forms an independent pharmaceutical-production enterprise, it shall handle the Pharmaceutical Production License procedures, in accordance with the provisions of Articles 4 and 5 of the present Measures.
Article 7 The food and drug administration departments of the provinces, autonomous regions and municipalities directly under the Central Government, after receiving an application, shall handle the application, in accordance with the following circumstances:
1. If the matters applied for do not fall within the scope of functions and powers of the corresponding department, the department shall make a decision to not accept the application, and shall notify the applicant to apply to the relevant administrative department;
2. If the application documents contain mistakes that can be corrected on the spot, the applicant shall be allowed to make the correction on the spot;
3. If the application documents are incomplete or do not comply with the requirements for the examination on the format, the department shall issue the Notice on Supplementing and Correcting the Documents to the applicant, either on the spot or within 5 working days, and notify the applicant of all the contents to be supplemented and/or corrected. If it fails to notify the applicant within the time limit, the date of acceptance shall be the date when the department has received the application documents; and
4. If the application documents are complete and comply with the examination requirements, or if the applicant has submitted all the supplementary documents as required, the application shall be accepted.
If any food and drug administration department of the provinces, autonomous regions and municipalities directly under the Central Government accepts, or does not accept, the application to establish a pharmaceutical-production enterprise, it shall issue a Notice of Acceptance or Notice of Non-acceptance, which shall be sealed by the special seal of the corresponding department, and indicated with the date thereof.
Article 8 The food and drug administration department of the provinces, autonomous regions and municipalities directly under the Central Government shall make a decision within 30 working days after the application is accepted.
If the application fulfills the requirements, after examination, the department shall grant approval, and shall verify and issue the Pharmaceutical Production License within 10 working days from the date when the decision on written approval. If the application does not fulfill the requirements, the department shall issue a written rejection, and shall explain the reasons for the decision.
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Order of the China Food and Drug Administration No.37
November 17, 2017
(Promulgated by the Order of the China Food and Drug Administration No.14 on August 5, 2004; and amended in accordance with the Decision of the China Food and Drug Administration on Revising Some Rules at the executive meeting of the China Food and Drug Administration on November 7, 2017)
Chapter I General Provisions
Article 1 To strengthen the supervision over and administration of pharmaceutical production, the present Measures have been formulated in accordance with the Drug Administration Law of the People's Republic of China (Pharmaceutical Administration Law) and the Implementing Regulations of the Drug Administration Law of the People's Republic of China (Regulation).
Article 2 Supervision over and administration of pharmaceutical production shall refer to activities, among other administrative activities, of food and drug administration departments that examine, license, supervise and inspect pharmaceutical production conditions and processing.
Article 3 The China Food and Drug Administration shall be responsible the nationwide supervision and administration of pharmaceutical production. The food and drug administration departments of the provinces, autonomous regions and municipalities directly under the Central Government are responsible for the supervision and administration of pharmaceutical production within their respective administrative regions.
Chapter II Application, Examination and Approval to Establish Pharmaceutical-production Enterprises
Article 4 When launching a pharmaceutical-production enterprise, the following conditions must be met, in addition to the pharmaceutical industry development plan and the State's industrial policies:
1. Have technicians, in pharmacology, engineers, technicians and corresponding technical workers whose qualifications are certified; and the legal representative, or the person responsible for the enterprise, and the person in charge of quality do not fall under any of the circumstances outlined in Article 76 of the Pharmaceutical Administration Law;
2. Have workshops, facilities and a sanitation environment suitable for pharmaceutical production;
3. Have institutions, personnel capable of quality control and inspecting the pharmaceuticals produced, and the necessary apparatuses and equipment; and
4. Have regulations to ensure the quality of the pharmaceutical products.
If relevant State laws and regulations contain different provisions on the production of narcotic pharmaceuticals; psychotropic pharmaceuticals; toxic pharmaceuticals, for medical treatments; radioactive pharmaceuticals; and/or precursor chemicals, of the pharmaceutical category, the provisions shall apply.
Article 5 An applicant who intends to launch a pharmaceutical-production enterprise shall file an application to the food and drug administration department of the province, autonomous region or municipality directly under the Central Government at his/her/its locality, and he/she/it shall submit the following documents:
1. Basic information about the applicant and pertinent certificates and relevant documents;
2. Basic conditions of the enterprise to be launched, including the name of the enterprise, types of production, type of pharmaceuticals equipment, techniques and throughput; statements about the site of the enterprise, environment around the site, and infrastructure, etc., as well as statements about the investment scale and other conditions;
3. corporate business license, productions address and registered address, type of enterprise, legal representative or the person responsible for the enterprise;
4. Organization plan for the enterprise to be launched (indicating the functions of each sector and their correlation, and the person responsible for each sector);
5. Resumes, educational backgrounds and title certificates of the legal representatives and people responsible for the enterprise to be launched, and for the people responsible for each sector of the enterprise; the registration forms for the technicians of pharmacology and relevant professionals, engineers and technicians, and technical workers, whose qualifications have been certified, with an indication of the sectors they will be in and the posts they will hold; the proportion statement of the senior, medium and preliminary technicians;
6. Map detailing the environment around the enterprise to be launched, general plane figure, storage plane figure, plane figure of quality inspection place;
7. Plan for the arrangement of production techniques of the enterprise (including dressing room, water closet, passage for stream of people and material circulation, and air brake, etc., and indicating the flow of the people and materials and the grade of air cleanliness factor), plan of the blowing, returning and ventilation of the air-cleansing system, and the plan for the arrangement of techniques and equipment;
8. The scope, type of pharmaceuticals varieties, quality standards and the basis of the pharmaceuticals to be produced;
9. The technical flow chart of the type of pharmaceuticals and varieties of pharmaceuticals to be produced, with the major quality reference points and items indicated;
10. The general situation regarding the validation of the air-cleansing system, water-treatment system and the major equipment; conditions of the checkout of the production and inspection apparatuses, instruments and weighing apparatuses;
11. Lists of major production equipment and inspection apparatuses; and
12. The contents of documents regarding production management and quality control of the enterprise to be launched.
The applicant shall be responsible for the truthfulness of all contents contained within the application documents.
Article 6 If a pharmaceutical-production enterprise divides part of its production workshops and forms an independent pharmaceutical-production enterprise, it shall handle the Pharmaceutical Production License procedures, in accordance with the provisions of Articles 4 and 5 of the present Measures.
Article 7 The food and drug administration departments of the provinces, autonomous regions and municipalities directly under the Central Government, after receiving an application, shall handle the application, in accordance with the following circumstances:
1. If the matters applied for do not fall within the scope of functions and powers of the corresponding department, the department shall make a decision to not accept the application, and shall notify the applicant to apply to the relevant administrative department;
2. If the application documents contain mistakes that can be corrected on the spot, the applicant shall be allowed to make the correction on the spot;
3. If the application documents are incomplete or do not comply with the requirements for the examination on the format, the department shall issue the Notice on Supplementing and Correcting the Documents to the applicant, either on the spot or within 5 working days, and notify the applicant of all the contents to be supplemented and/or corrected. If it fails to notify the applicant within the time limit, the date of acceptance shall be the date when the department has received the application documents; and
4. If the application documents are complete and comply with the examination requirements, or if the applicant has submitted all the supplementary documents as required, the application shall be accepted.
If any food and drug administration department of the provinces, autonomous regions and municipalities directly under the Central Government accepts, or does not accept, the application to establish a pharmaceutical-production enterprise, it shall issue a Notice of Acceptance or Notice of Non-acceptance, which shall be sealed by the special seal of the corresponding department, and indicated with the date thereof.
Article 8 The food and drug administration department of the provinces, autonomous regions and municipalities directly under the Central Government shall make a decision within 30 working days after the application is accepted.
If the application fulfills the requirements, after examination, the department shall grant approval, and shall verify and issue the Pharmaceutical Production License within 10 working days from the date when the decision on written approval. If the application does not fulfill the requirements, the department shall issue a written rejection, and shall explain the reasons for the decision.
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