The new version of the "Administrative Measures for Drug Production Supervision and Management" has been implemented in China, which adopts a series of measures to simplify government procedures and delegate administrative power. The most significant measure is the cancellation of GMP certification for drugs. In the future, inspections will be based on risk, and the main focus of regulatory compliance will be on ensuring the continuous compliance of enterprises.
One of the most important changes under the new measures is stricter regulations for drug production access, and the implementation of classified management for production permits. Firstly, holders of marketing licenses and entrusted production enterprises are required to apply for a production permit. Consideration is given to the basic principle of localized supervision of drugs, and therefore marketing license holders of entrusted drugs are also included in the scope of production permit management, and must apply for a production permit from the provincial drug supervision department where they are located. Secondly, those involved in the production of formulations, APIs, and traditional Chinese medicine decoction pieces are also required to apply for a production permit. APIs are still subject to administrative licensing in China, which can be a separate review and approval process or a related evaluation and approval process, and are subject to production permit management. Thirdly, the production permit has added an English letter classification code, with a capital letter representing the type of production subject and a lowercase letter representing the properties of the preparation. For example, A represents the holder of self-production, B represents the holder of entrusted production, C represents the receiving entrusted production enterprise, and D represents the API production enterprise.
These new measures are intended to streamline government administration, reduce regulatory compliance costs for enterprises and promote innovation in the pharmaceutical industry. The measures will also require enterprises to take full responsibility for ensuring the safety and effectiveness of their drugs, and abide by the relevant regulations and standards throughout the entire production process. With the new measures in place, China's drug production supervision and management will become more targeted, efficient, and standardized, which will better safeguard public health and safety.