Requirements on Registering Domestic Production of Drugs Produced and Marketed Overseas.
Edited Time: March 27, 2023Edited by: adminCategory: Publications
On 23 March 2023, the Center for Drug Evaluation, NMPA, released the exposure draft of the Requirements on Application Materials for Registering Domestic Production of Drugs Produced and Marketed Overseas (Chemicals) to solicit public opinions.
The Requirements mainly clarify the materials that can be streamlined or waived, compared with the requirements on the application for the registration of generic drugs.
Furthermore, in view of the actual and changed situations for domestic production of drugs which have been produced overseas, the Requirements specify the application materials that can be streamlined in relation to prescription and technology, control of raw and auxiliary materials, research on preparation quality, packaging materials, stability research and etc.