NMPA to Regulate the Application for Marketing Authorization of Overseas-Manufactured Drugs Already Marketed Domestically to Be Shifted to Domestic Manufacturing
The National Medical Products Administration (NMPA) has released the Announcement on Relevant Matters Concerning Optimizing the Application for Marketing Authorization of Overseas-Manufactured Drugs Already Marketed Domestically to Be Shifted to Domestic Manufacturing (the "Announcement").
According to the Announcement, if an overseas-manufactured drug already marketed domestically is intended to be shifted to domestic manufacturing, an application shall be submitted by the domestic applicant as per the requirements and procedures for drug marketing authorization. For overseas-manufactured drugs already marketed domestically and intended to be shifted to domestic manufacturing, the original registration application materials for the overseas-manufactured drug may be submitted, along with relevant research materials related to the shift to domestic manufacturing, so as to support the drug marketing authorization. The specific requirements for the application materials will be separately provided and published by the Center for Drug Evaluation of the National Medical Products Administration. The Announcement also specifies that, applications for marketing authorization of original chemical drugs and biologics to be shifted to domestic manufacturing will be included in the scope of priority review and approval by NMPA.