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Laws & Regulations - Drugs - Provisions for Drug Manufacturing Supervision
Provisions for Drug Manufacturing Supervision
 
2012/3/20 14:29:20¡¡Source: ¡¡Hits:

Chapter 1 General Provisions
Article 1 The Provisions is formulated with a view of strengthening supervision over drug manufacturing and in accordance with the Drug Administration Law of the People¡¯s Republic of China and Regulations for Implementation of the Drug Administration Law of the People¡¯s Republic of China (hereinafter referred to as the Drug Administration Law and Regulations for Implementation of the Drug Administration Law).

Article 2 Supervision over drug manufacturing refers to administrative activities including examination, approval, supervision and inspection on the condition and process of drug manufacturing£¬which are conducted by (food and) drug regulatory departments in accordance with law.

Article 3 The State Food and Drug Administration is responsible for the supervision and administration of drug manufacturing throughout the country; the (food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for supervision and administration of drug manufacturing within their respective administrative areas.

Chapter 2 Application and Approval for Establishment of A Drug Manufacturer
Article 4 To establish a drug manufacturer, the applicant shall, besides complying with the development programs and policies issued by the State for pharmaceutical industry, meet the following requirements:
(1) Having legally qualified pharmaceutical personnel, engineering personnel and necessary technical workers, and the legal representative or head of the enterprise and person in charge of quality are not involved in any of the situations specified in Article 76 of the Drug Administration Law;
(2) Having factory buildings, facilities and a sanitary environment appropriate for its drug manufacturing;
(3) Having organizations, personnel and necessary instruments and equipment appropriate for quality control and testing of the drugs to be produced.
(4) Having rules and regulations ensuring quality of its drugs.
Where there are other provisions on manufacturing of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs or pharmaceutical precursor chemicals in relevant laws and regulations of the State, these provisions shall prevail.

Article 5 The applicant for establishment of a drug manufacturer shall file an application with the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government, where the manufacturer is to be located, and submit the following materials.
(1) Basic information of the applicant and relevant proof documents;
(2) Basic information about the manufacturer to be established, including name of the manufacturer, product variety and dosage form(s), equipment, processes and production capacity; description of conditions such as the site, surroundings and infrastructure of the manufacturer and explanation on investment size;
(3) Notice of pre-approval on the name of the manufacturer to be established issued by the administrative department for  industry and commerce, address of manufacturing address of manufacturing site, registered address, type of enterprise and legal representative or head of the enterprise;
(4) Organization chart of the manufacturer to be established (responsibilities of various departments, their interrelations and heads shall be indicated);
(5) Resumes, educational qualifications and professional title certificates of the legal representative, head and department heads of the enterprise to be established; registration forms of legally qualified pharmaceutical professionals, engineering personnel and technical workers in the pharmaceutical field and relevant fields (their departments and positions shall be indicated); proportion statement of senior, intermediate and junior technical personnel.
(6) Plan of surrounding areas, master plan layout, warehouse plan and quality inspection site plan of the manufacturer to be established;
(7) Layout chart of production processes (including change room, lavatory, passages for people and materials, air lock, etc., and directions of flows of people and materials and air cleanliness class shall be indicated), layout chart of air purification system indicating air supply, air return and discharge pipes and layout chart of processing equipment;
(8) Range, dosage forms and varieties of products to be produced, and quality specifications with their basis;
(9) Process flow chart of the dosage form and variety of product to be produced. Main quality control points and items shall be indicated;
(10) Summary of verification on the air purification system, water generation system and main equipment; information on calibration of instruments, meters and weighing apparatuses for production and testing;
(11) List of main production equipment and testing instruments;
(12) List of production management and quality management documents of the manufacturer to be established.
The applicant shall be responsible for the authenticity of all the application materials.

Article 6 Where a drug manufacturer spins off part of its production plants into an independent drug manufacturer, a Drug Manufacturing Certificate shall be applied for  in accordance with requirements of Article 4 and Article 5 of the Provisions.

Article 7 After receiving an application, the (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall handle the application according to the following situations:
(1) Where an application item is not subject to the jurisdiction of the department, the department shall immediately make a non-acceptance decision and advise the applicant to apply to a relevant administrative authority;
(2) Where an error in the application dossier can be corrected on the spot, on-the-spot correction shall be allowed;
(3) Where the dossier is incomplete or not conformed with the defined format, the applicant shall be given a Notice for Supplementary Materials on the spot or within five working days, in which all the content required to be supplemented and corrected are informed at one time; where the applicant is not informed within the timeline, the application is deemed as accepted on the date the dossier is received;
(4) Where the application dossier is complete and in compliance with the requirements of preliminary review or the applicant has submitted all the materials added and corrected as required, the application shall be accepted.
Where the (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government accepts or rejects an application for establishment of a drug manufacturer, it shall issue a dated Acceptance Notice or Non-acceptance Notice affixed with the specified seal for acceptance of the department.

Article 8 The (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall make a decision within 30 working days from the date an application is received.
Where the application is confirmed in compliance with the requirements after review, the department shall approve the application and issue a Drug Manufacturing Certificate to the applicant within 10 working days from the date it makes the approval decision in writing; where the application is found not in compliance with the requirements, the department shall make a disapproval decision in writing, explain the reason thereof and meanwhile inform the applicant of the right to apply for an administrative reconsideration or to bring an administrative suit by law.

Article 9 To establish a new drug manufacturer or to build a new drug production plant or to add a new dosage form, the manufacturer shall, within 30 days from the date of obtaining the certificate for drug production or the approval for formal production, apply for a Good Manufacturing Practice for Pharmaceutical Products (GMP) certification with relevant (food and) drug regulatory department in accordance with relevant regulations of the State Food and Drug Administration.

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