National Medical Products Administration, Announcement on Matters Relating to Optimizing the Application for Registration of the Marketing of a Domestically Marketed Foreign Produced Pharmaceutical the Production of Which is to Switch to Mainland China

国家药监局关于优化已在境内上市的境外生产药品转移至境内生产的药品上市注册申请相关事项的公告

May 17, 2024 | BY

Susan Mok

Procedures are facilitated for marketing of domestically produced foreign pharmaceuticals

Issued: April 19, 2024

Main contents: Where the production of a domestically marketed foreign produced pharmaceutical is to switch to mainland China, the application shall be submitted by the domestic applicant in accordance with the requirements and by the procedure for applying for registration of the marketing of pharmaceuticals (Article 1).

Where the production of a domestically1 marketed foreign2 produced pharmaceutical is to switch to mainland China, the original registration filing information for the foreign produced pharmaceutical and the relevant research data for the switch to domestic1 production may be submitted in support of the application for registration of the marketing of the pharmaceutical. The specific requirements in respect of the filing information shall be formulated and issued separately by the Center for Drug Evaluation of the National Medical Products Administration.

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