First, the production supervision authority of the drug supervision department:
In order to strengthen the supervision of drug production and clarify the division of supervision authority, the Measures for the Supervision and Administration of Drug Production, on the basis of adhering to the principle of territorial supervision, refines the supervision authority of drug supervision departments in drug production, clarifies powers and responsibilities, and ensures the implementation of drug production supervision.
1, it is clear that the State Administration of Pharmaceutical Products is in charge of the supervision and administration of pharmaceutical production in the whole country, and it also supervises and guides the supervision and administration of pharmaceutical production in the provincial drug supervision departments.
2. The Verification Center of the State Administration of Pharmaceutical Products organizes the formulation of technical specifications and documents for drug inspection, undertakes overseas inspection and organizes vaccine inspection, analyzes and evaluates the risks found in the inspection, makes inspection conclusions and puts forward disposal suggestions, and is responsible for the guidance and evaluation of the quality management system of provincial drug inspection institutions.
3 National Pharmaceutical Product Supervision Information Center is responsible for the construction and management of drug traceability collaborative service platform, drug safety credit files and unified coding of drug production sites.
4, adhere to the principle of territorial supervision, the provincial drug supervision department is responsible for the supervision and management of drug production within their respective administrative areas, and undertake the licensing, inspection and punishment of drug production.
Second, apply for a drug production license:
The Drug Administration Law stipulates that anyone who engages in drug production activities shall obtain a drug production license. This is the starting point and necessary condition of drug production. The Measures for the Supervision and Administration of Pharmaceutical Production stipulates the conditions for issuing production licenses, the time limit for handling procedures and the requirements for on-site inspection.
1 specifies the conditions for obtaining a production license. Engaged in drug production, should have five conditions, such as personnel, facilities and equipment, quality management, inspection equipment, quality assurance rules and regulations. In addition, special regulations have been made for vaccine manufacturers.
2. It stipulates the licensing procedures and time limit requirements. The applicant shall, in accordance with the requirements of the application materials, apply to the local provincial drug supervision and administration department. After receiving the application, the provincial drug supervision and administration department shall decide whether to accept or approve it within the prescribed time limit according to different situations. It is clear that all time in the drug production license is counted as working days, and the time required for technical review, on-site inspection and enterprise rectification is not included in the time limit. At the same time, the drug supervision and administration department shall disclose the examination and approval results and provide conditions for the applicant to inquire about the examination and approval process.
3. The changed content has been specified. The contents of changes in registered items and licensing items are stipulated, and the time limit for handling license changes is clarified. If it is not changed, the provincial drug supervision and administration department shall explain the reasons in writing and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.
4. The license shall be issued at the expiration of the validity period. If it is necessary to continue to produce drugs after the expiration of the validity period of the license, it shall apply to the original issuing authority for a new drug production license six months before the expiration of the validity period. After comprehensive evaluation, the original issuing authority shall make a decision on whether to renew the license before the expiry of the validity period of the Pharmaceutical Production License. If no decision is made within the time limit, it shall be deemed that the license has been renewed and the corresponding formalities shall be handled.
At the same time, the Measures for the Supervision and Administration of Pharmaceutical Production also stipulates the procedural requirements for license renewal, cancellation, cancellation and cancellation.
Legal basis: Measures for the Supervision and Administration of Pharmaceutical Production
Article 2 The production, supervision and administration of listed drugs within the territory of People's Republic of China (PRC) shall abide by these Measures.
Article 3 When engaging in pharmaceutical production activities, it shall abide by laws, regulations, rules, standards and norms, and ensure that the information in the whole process is true, accurate, complete and traceable.
Engaged in pharmaceutical production activities shall be approved by the local pharmaceutical supervisory and administrative departments of provinces, autonomous regions and municipalities directly under the Central Government, obtain pharmaceutical production licenses according to law, strictly abide by good manufacturing practice, and ensure that the production process continues to meet the statutory requirements.
The holder of the drug marketing license shall establish a drug quality assurance system, fulfill the responsibility of drug marketing and release, and be responsible for the drug quality of the drug registration certificate obtained by him.
Chinese herbal pieces production enterprises shall fulfill the relevant obligations of drug marketing license holders to ensure that the production process of Chinese herbal pieces continues to meet the statutory requirements.
Raw material drug production enterprises shall organize production according to the approved production process, strictly abide by good production practices, and ensure that the production process continues to meet legal requirements.
Production enterprises that have direct contact with pharmaceutical excipients, packaging materials and containers and other units and individuals engaged in pharmaceutical production activities shall bear corresponding responsibilities according to law.