#Chinese Legal Service #Chinese Lawyer #PRC lawyer #PRC Legal Service #Drugs Administration #
The “Interim Provisions on the Administration of Domestic Responsible Persons Designated by Overseas Drug Marketing Authorization Holders” issued by the National Medical Products Administration (NMPA) of China are aimed at enhancing the oversight of overseas drug Marketing Authorization Holders (MAHs) and clarifying the rights and responsibilities of these entities and their designated domestic responsible persons within China.
Key Components of the Provisions:
1. Designation of Responsible Persons: The provisions mandate that for each drug variety marketed in China, an overseas MAH must appoint a single responsible person within the country to fulfill the obligations of the drug marketing authorization holder. This designated person may accept appointments from different overseas MAHs and for different imported drug varieties, streamlining the management process.
2. Reporting and Authorization Process: Overseas MAHs are required to report their designated domestic responsible person to the provincial medical products administration bureau where the designated person is located, through the national drug business application system, along with uploading the authorization materials. Any changes to the domestic responsible person must be reported within 15 working days after the new authorization letter takes effect.
3. Transition Period and Compliance Deadline: Overseas manufactured drugs already on the market must ensure that a domestic responsible person is designated, and all relevant materials are reported and filed as required during the transition period. This period, which lasts approximately 8 months, allows overseas MAHs to select an eligible domestic responsible person. From July 1, 2025, all overseas manufactured drugs that are produced or released must comply with the requirements of the Interim Provisions, with information on the responsible person within the country included in the instructions.
Analysis:
The introduction of these provisions signifies a significant step towards formalizing the role of domestic responsible persons for overseas MAHs in China. This move not only strengthens the regulatory framework for international pharmaceutical companies but also ensures a more transparent and accountable drug supply chain within the country.
By requiring overseas MAHs to appoint a domestic responsible person, the NMPA ensures that there is a clear point of contact and accountability within China for any issues related to the drugs marketed by these companies. This appointment facilitates better communication and coordination between the overseas MAHs and Chinese regulatory authorities, which is crucial for the timely resolution of regulatory and compliance issues.
The reporting and authorization process, as outlined in the provisions, standardizes the way overseas MAHs interact with the Chinese regulatory system, ensuring that all necessary information is provided and updated in a consistent manner. This process is essential for maintaining an accurate and up-to-date record of all designated responsible persons and their associated MAHs.
The transition period and compliance deadline provide a clear timeline for overseas MAHs to adjust their operations to meet the new requirements. This allows companies to plan and execute the necessary changes without being subjected to immediate enforcement actions, thus promoting a smooth transition to the new regulatory environment.
In conclusion, the “Interim Provisions on the Administration of Domestic Responsible Persons Designated by Overseas Drug Marketing Authorization Holders” are an important regulatory development that enhances the management and supervision of overseas MAHs in China. These provisions contribute to the safety, efficacy, and traceability of drugs within the Chinese market by ensuring that overseas companies have a designated point of responsibility within the country.
China on the Move: New Level of Opening up in Health Care Sector | Insights | Greenberg Traurig LLP