Measures for the Supervision over and Administration of Pharmaceutical Production (2017 Amendment)

Measures for the Supervision over and Administration of Pharmaceutical Production (2017 Amendment) Measures for the Supervision over and Administration of Pharmaceutical Production (Promulgated by the Order No. 14 of the China Food and Drug Administration on August 5, 2004; and amended in accordance with the Decision to Amend Certain Rules adopted at the executive meeting of the China Food and Drug Administration on November 7, 2017) Chapter I General Provisions Article 1 With a view to strengthening the supervision over and administration of pharmaceutical production, the present Measures are formulated in accordance with the Pharmaceutical Administration Law of the People's Republic of China , Regulation on the Implementation of the Pharmaceutical Administration Law of the People's Republic of China (hereinafter referred to as the Pharmaceutical Administration Law , Regulation on the Implementation of the Pharmaceutical Administration Law ). Article 2 The supervision over and administration of pharmaceutical production shall refer to the activities of food and drug administrative departments who make examination, licensing, supervision and inspection on pharmaceutical production conditions and process and other administrative activities. Article 3 The China Food and Drug Administration shall take charge of the work of supervision over and administration of pharmaceutical production nationwide. The food and drug administrative departments of the provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the supervision over and administration of pharmaceutical production within their own administrative regions. Chapter II Application for and Examination and Approval of the Launching of Pharmaceutical Production Enterprises Article 4 When launching a pharmaceutical production enterprise, the following conditions shall also be met in addition to meeting the pharmaceutical industry development plan and industrial policies of the state: 1. Having technicians in pharmacology, engineers and technicians and corresponding technical workers whose qualifications have been certified; and the legal representative or responsible person of the enterprise and the person in charge of quality having no circumstances as prescribed in Article 75 of the Pharmaceutical Administration Law ; 2. Having workshops, facilities and sanitation environment fitting in with pharmaceutical production; 3. Having institutions, personnel that are able to make quality control and inspection on the pharmaceuticals produced, and necessary apparatus and equipment; and 4. Having regulations that can ensure the pharmaceutical quality. In case the relevant state laws and regulations have different provisions on the production of narcotic pharmaceuticals, psychotropic pharmaceuticals, toxic pharmaceuticals for medical treatment use, radioactive pharmaceuticals, precursor chemicals of the pharmaceutical category, etc., those provisions shall be followed. Article 5 An applicant for launching a pharmaceutical production enterprise shall file an application to the food and drug administrative department of the province, autonomous region, or municipality directly under the Central Government at his/its locality, and submit the following documents: 1. Basic information of the applicant and the relevant certificate documents; 2. Basic conditions of the planned enterprise, including the name of the planned enterprise, varieties of production, type of medicament, equipment, technics and throughput; statements on the site of the enterprise, environment around the sites, and infrastructures, etc., as well as the statements on investment scale and other conditions; 3. Business license of the enterprise, production address and registered address, type of the enterprise, legal representative or the person in charge of the enterprise; 4. Plan of the organizations of the planned enterprise (indicating the functions of each sector and their correlations, responsible person of each sector); 5. Resumes, educational backgrounds and title certificates of the legal representative, responsible person of the planned enterprise and the responsible person of each sector of the enterprise; registration form for the technicians of pharmacology and relevant professionals, engineers and technicians, technical workers whose qualifications have been certified according to law with the indication of the sectors and posts they are in; the proportion statement of the senior, medium and preliminary technicians; 6. The map for the environment around the planned enterprise, general plane figure, storage plane figure, plane figure of quality inspection place; 7. Plan for the arrangement of production technics of the enterprise (including dressing room, water closet, passage for stream of people and material circulation, and air brake, etc., and indicating the flowing direction of the people and materials and the grade of air cleanliness factor), plan of the blow, return and ventilation of air cleansing system, and the plan for arrangement of technics and equipment; 8. The scope, type of medicament, varieties, quality standard and basis of the pharmaceuticals to be produced; 9. The technic flow chart of the type of medicament and varieties of pharmaceuticals to be produced, with the major quality reference points and items indicated; 10. General situation on the validation of air cleansing system, water treatment system and the major equipment; conditions of checkout of the production and inspection apparatus, instruments, and weighing apparatus; 11. Lists of major production equipment and inspection apparatus; and 12. Contents of documents on the production management and quality control of the planned enterprise. The applicant shall be responsible for the truthfulness of all the contents of the application documents. Article 6 In case a pharmaceutical production enterprise divides part of the production workshops and forms an independent pharmaceutical production enterprise, it shall handle the Pharmaceutical Production License in accordance with the provisions of Articles 4 and 5 of the present Measures. Article 7 The food and drug administrative departments of the provinces, autonomous regions, and municipalities directly under the Central Government shall, after receiving the application, make handling according to the following circumstances respectively: 1. In case the matters applied for do not fall within the scope of functions and powers of the corresponding department according to law, the department shall make decision on not accepting it, and notify the applicant to apply to the relevant administrative department; 2. In case the application documents have mistakes that can be corrected on the spot, the applicant shall be allowed to correct on the spot; 3. In case the application documents are incomplete or do not correspond with the requirements for the examination on the format, the department shall issue the Notice on Supplementing and Correcting the Documents to the applicant on the spot or within 5 workdays, and notify the applicant of all the contents to be supplemented and corrected. If it fails to notify 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 correspond with the examination requirements, or the applicant has submitted all the supplementary documents as required, the application shall be accepted. In case any food and drug administrative department of the provinces, autonomous regions, and municipalities directly under the Central Government accepts or does not accept the application for the establishment of the pharmaceutical production enterprise, it shall issue a Notice of Acceptance or Notice of Not Acceptance, which is sealed by the special seal of the corresponding department and indicated with the date thereof. Article 8 The food and drug administrative department of the provinces, autonomous regions, and municipalities directly under the Central Government shall make decision within 30 workdays after the application is accepted. If the application meets the requirements after examination, the department shall grant approval, and verify and issue the Pharmaceutical Production License within 10 workdays from the date when the decision on written approval has been made. If the application does not meet the requirements, the department shall make a written decision on not approval, and explain the reasons, meanwhile notify the applicant of his right to apply for administrative reconsideration or file an administrative litigation according to law. Article 9 In case of establishing a new pharmaceutical production enterprise, or a pharmaceutical production enterprise builds a new pharmaceutical production workshop or newly adds production form of prepared pharmaceuticals, the enterprise shall apply for certification of the Pharmaceutical Production Quality Control Criterions to the corresponding food and drug administrative department in accordance with the provisions of the China Food and Drug Administration within 30 days from the date of obtaining pharmaceutical production certificate documents or from the date when it is approved to make production officially. Article 10 The food and drug administrative department of the provinces, autonomous regions, and municipalities directly under the Central Government shall make a public notice on the website or at the office place of the administrative department on the conditions, procedures and time limit for applying for the Pharmaceutical Production License, the whole documents to be submitted and the model text of the application letter, etc.. The food and drug administrative department of the provinces, autonomous regions, and municipalities directly under the Central Government shall open the relevant information on the issuance of Pharmaceutical Production License. The general public shall have the right to consult. Article 11 The food and drug administrative department of the provinces, autonomous regions, and municipalities directly under the Central Government shall make a public notice on the process and result of examination and approval when making examination on the application of the pharmaceutical production enterprise. The applicant and the interested parties may submit written opinions to make statements and defense on the matters directly relating to their major interests. Article 12 In case the application for the establishment of any pharmaceutical production enterprise directly involves major interest relations between the applicant and others, the food and drug administrative department of the provinces, autonomous regions, and municipalities directly under the Central Government shall notify the applicant and the interested parties that they may enjoy the right to apply for hearing according to laws and regulations and other provisions of China Food and Drug Administration. When making examination on the application for establishment of pharmaceutical production enterprises, the food and drug administrative department of the provinces, autonomous regions, and municipalities directly under the Central Government shall make a public notice to the society on the major licensing matters concerning the public interests, and hold hearings. Chapter III Administration on Pharmaceutical Production License Article 13 The Pharmaceutical Production License shall have the original copy and the duplicate, the duplicate shall have the same legal effect as the original one, and the period of validity shall be five years. The Pharmaceutical Production License shall be printed uniformly by the China Food and Drug Administration. Article 14 The Pharmaceutical Production License shall bear the serial number of the License, name of the enterprise, legal representative, enterprise type, registration address, production address, production scope, license issuing organ, date for license issuance, period of validity, and other items, etc.. Among them the licensing matters that are subject to the approval of the food and drug administrative department shall be: responsible person of the enterprise, scope of production, and production address......