NMPA News: China’s National Medical Products Administration (NMPA) has released for public comments a draft announcement on administration of registration renewal of chemical active pharmaceutical ingredients (APIs)

in early November. It is expected that the official announcement will be finalized soon and will facilitate the Drug Master File (DMF) process in China in future.

According to the new draft policy, chemical APIs with an existing approval number (incl. import registration number) will no longer receive an approval notice. Similar as general pharmaceutical drug products, chemical APIs will have their approval notice valid for 5 years upon approval date and will require the applicant to submit a DMF renewal application in China for their APIs.

In addition, there will be a 1-year transition period granted for submission of renewed registration. It is noteworthy that there are different policies for chemical APIs with different remaining effective period on their approval certificates.

Therefore, it is crucial for the MA holders and the applicants of DMF in China to keep track of the timeframe and submit the necessary materials for the renewal of registration before the deadline.

For advisory on complying with inspection requirements and China’s GVP, Accestra is your professional and reliable partner in all these affairs.

Contact Us

For more information or request for solutions that tailored to your product, please email: info@accestra.com

We would be more than happy to arrange a teleconference call to share an overview of the China drug registration requirements, costs, and timelines. Email us to arrange a date and time to call (Info@accestra.com).