National Medical Products Administration, Provisions for the Oversight of the Production of Export Pharmaceuticals (Draft for Comments)

国家药品监督管理局出口药品生产监督管理规定 (征求意见稿)

August 26, 2024 | BY

Susan Mok

Export pharmaceuticals commissioned for production from a foreign pharmaceutical manufacturer may not be sold and used in the PRC

Promulgated: 2024-08-01

Issued: August 1, 2024

Main contents: The Provisions detail information relating to acceptance of a commission for production from a foreign1 pharmaceutical manufacturer. They set forth the concepts and basic requirements relating to acceptance of the foreign commission and set forth the requirements in respect of the reporting of the commissioned enterprise to the pharmaceutical regulator, reviewing the qualifications of the commissioning party and management of the products, materials, etc. (Articles 29 – 33)

Export pharmaceuticals produced in connection with the acceptance of a commission from a foreign pharmaceutical manufacturer may not be sold and used in mainland China and the commissioned enterprise may not further sub-commission the production of such pharmaceutical to a third party (Articles 29 and 34).

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1 .  Meaning outside of mainland China
issued: 2024-08-01

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