Chapter I General Provisions Article 1 In order to strengthen the supervision and administration of pharmaceutical production, these Measures are formulated in accordance with the Drug Administration Law of People's Republic of China (PRC) and the Regulations for the Implementation of the Drug Administration Law of People's Republic of China (PRC) (hereinafter referred to as the Drug Administration Law and the Regulations for the Implementation of the Drug Administration Law). Article 2 The supervision and administration of drug production refers to the management activities such as examination, licensing, supervision and inspection of drug production conditions and production processes by the (food) drug supervision and administration department according to law. Article 3 The State Food and Drug Administration of the United States shall be in charge of the supervision and administration of drug production throughout the country. The (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the supervision and administration of drug production within their respective administrative areas. Chapter II Application and Examination and Approval for the Establishment of Pharmaceutical Production Enterprises Article 4 To establish a pharmaceutical production enterprise, in addition to complying with the development plan and industrial policy of the pharmaceutical industry formulated by the state, it shall also meet the following conditions:

(1) It has qualified pharmaceutical technicians, engineering technicians and corresponding skilled workers according to law, and the legal representative of the enterprise or the person in charge of the enterprise or the person in charge of quality does not have the circumstances stipulated in Article 76 of the Drug Administration Law;

(2) Having factories, facilities and sanitary environment suitable for its pharmaceutical production;

(3) Having institutions, personnel and necessary instruments and equipment capable of quality management and quality inspection of the drugs produced;

(4) Having rules and regulations to ensure the quality of drugs.

Where the relevant laws and regulations of the state have other provisions on the production of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs and pharmaceutical precursor chemicals, those provisions shall prevail. Article 5 To apply for establishing a pharmaceutical production enterprise, an application shall be submitted to the (food) drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the enterprise is to be established, and the following materials shall be submitted:

(a) the basic information of the applicant and its relevant documents;

(two) the basic information of the proposed enterprise, including the name of the proposed enterprise, production varieties, dosage forms, equipment, technology and production capacity; A description of the site selection, surrounding environment, infrastructure and investment scale of the proposed enterprise;

(3) Notice of pre-approval of the name of the enterprise to be established issued by the administrative department for industry and commerce, production address and registered address, enterprise type, legal representative or person in charge of the enterprise;

(four) the organization chart of the proposed enterprise (indicating the responsibilities of each department, the relationship between each department and the person in charge of each department);

(5) Resumes, academic qualifications and professional titles of the legal representative, person in charge of the enterprise and department heads to be proposed; Registration forms for pharmaceutical and related professional and technical personnel, engineering and technical personnel and skilled workers who have passed the examination according to law, and indicate their subordinate departments and posts; Proportion table of senior, middle and junior technicians;

(six) the surrounding environment, general layout, warehouse layout and quality inspection site layout of the proposed enterprise;

(7) Layout plan of production process of the proposed enterprise (including dressing room, bathroom, pedestrian and logistics passage, air lock, etc.). , and indicate the direction of people flow, logistics and air cleanliness level), air supply, return air and exhaust layout of air purification system, and layout of process equipment;

(eight) the scope, dosage form, variety, quality standard and basis of the proposed production;

(nine) the process flow chart of the dosage form and variety to be produced, and indicate the main quality control points and projects;

(ten) verification of the main equipment of air purification system and water system; Calibration of production and inspection instruments, meters and weighing instruments;

(eleven) the main production equipment and inspection instruments;

(twelve) the production management and quality management documents of the proposed enterprise.

The applicant shall be responsible for the authenticity of all the contents of his application materials. Article 6 Where a pharmaceutical production enterprise divides some production workshops into independent pharmaceutical production enterprises, it shall apply for a Pharmaceutical Production License in accordance with the provisions of Articles 4 and 5 of these Measures. Article 7 After receiving the application, the (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall handle it according to the following circumstances:

(a) if the application matters are not within the scope of functions and powers of the department according to law, it shall immediately make a decision not to accept it, and inform the applicant to apply to the relevant administrative organ;

(2) 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;

(3) 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 working days to inform the applicant of all the contents that need to be supplemented at one time. If the application materials are not informed within the time limit, it shall be accepted as of the date of receipt of the application materials;

(four) the application materials are complete and meet the requirements of formal examination, or the applicant submits all supplementary materials as required, which shall be accepted.

Where the (food) drug supervision and administration department of a province, autonomous region or municipality directly under the Central Government accepts or rejects the application for establishing a pharmaceutical production enterprise, it shall issue a notice of acceptance or a notice of rejection stamped with the special seal of the accepting department and dated. Eighth provinces, autonomous regions and municipalities directly under the central government (food) drug supervision and management departments shall make a decision within 30 working days from the date of accepting the application.

If it meets the requirements after examination, it shall be approved, and the Pharmaceutical Production License shall be issued within 10 working days from the date of making a written approval decision; Do not meet the conditions, make a written decision not to approve, and explain the reasons, inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.