The National Medical Products Administration (NMPA) has released a notification regarding the implementation of the “Decision of the State Council on Amending and Abolishing Some Administrative Regulations.” This move is part of a broader effort to streamline regulatory processes and enhance market vitality in the medical sector.
Key Reforms and Changes
According to the document, from January 20, 2025, China will cancel the following approvals:
- “Approval of preparation for establishment of drug wholesale enterprises”
- “Approval of preparation for establishment of drug retail enterprises”
- “Approval of medical institutions to use radioactive drugs (Class I and II)”
Additionally, the “approval of Internet information services for drugs and medical devices” will be changed to a filing management system. This reform is a significant step in the State Council’s “Separating Operating Permits from Business Licenses” initiative, aimed at reducing bureaucratic red tape and stimulating market activity in the medical regulation field.
Post-Reform Procedures
After the cancellation of the above approval items, applicants seeking to establish drug wholesale and retail enterprises can file for a drug business license from the local medical products administration department at or above the county level, in accordance with relevant laws and regulations. Medical institutions that use radioactive drugs will no longer need to apply for a “Radioactive Drug Use License.” However, those using formulated radioactive preparations should apply to the provincial medical products administration for the issuance of a corresponding level of license.
For entities intending to provide Internet information services for drugs and medical devices, filing with the local provincial medical products administration department is required. Until specific measures for filing management are released, the filing materials must align with the requirements of the “Separating Operating Permits from Business Licenses” reform deepening pilot work, where submitting the materials equates to the completion of filing.
Ensuring Effective Implementation
To ensure the effective implementation of these reform measures, the document requires medical products administration departments at all levels to diligently implement their responsibilities for in-process and post-event supervision. This includes strengthening the quality supervision of drugs and medical devices throughout their entire process and life cycle, investigating and punishing illegal and irregular behaviors in accordance with the law, supervising enterprises to continue operating in compliance with the law, and effectively ensuring product quality and safety.
Strategic Implications
These reforms by the NMPA represent a significant shift towards a more streamlined and efficient regulatory environment for the drug and medical device industries. By reducing the administrative burden and enhancing regulatory clarity, the NMPA aims to foster innovation and market competition, ultimately benefiting patients through improved access to high-quality medical products.-Fineline Info & Tech
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