NMPA Announcement on Domestic Responsible Persons Designated by Overseas Drug Marketing Authorization Holders
ISSUING AUTHORITY:
National Medical Products Administration
DATE OF ISSUANCE:
November 13, 2024
EFFECTIVE DATE:
July 1, 2025
On November 13, the National Medical Products Administration (NMPA) announced the promulgation of the Interim Provisions on the Administration of Domestic Responsible Persons Designated by Overseas Drug Marketing Authorization Holders (To be effective) (“Interim Provisions”), which will take effect on July 1, 2025. The Interim Provisions consist of 18 articles, aiming to enhance the supervision and administration of overseas drug marketing authorization holders (MAHs), implement the primary responsibility for quality management after drugs are marketed, and regulate activities of designating domestic responsible persons by overseas drug MAHs.
There are two highlights of the Interim Provisions. One is that the domestic responsible person is jointly and severally liable with the MAH. The Interim Provisions define the domestic responsible person as a domestic enterprise with legal personality designated by an overseas holder to perform the obligations of the drug MAH within the territory of China and bear joint and several liability together with the drug MAH. Another is that the Interim Provisions clarify that a single variety of drugs shall be designated to the sole domestic sole responsible person, as set forth in Article 7. However, the same responsible person within the territory of China may be designated by different overseas holders for different varieties of imported drugs.
國家藥監(jiān)局關(guān)于發(fā)布《境外藥品上市許可持有人指定境內(nèi)責(zé)任人管理暫行規(guī)定》的公告
