On November 4, the NMPA released a draft regulation entitled “Announcement on the Administration of Chemical API Registration Renewal” and is seeking public comments by December 3. The announcement and regulation is expected to go into effect in one year.
Before the implementation of this announcement, API DMFs in China were expected to be renewed since approval is only valid for 5 years, but there were no regulations regarding renewal. Even though renewal of API DMFs has been a common practice, it has not been mandated by any China health authorities. The implementation of the announcement means that it will become mandatory for API DMF holders to renew their active DMFs. There are two types of active APIs – 1. Active APIs with an approval number are APIs that were registered prior to 2017 and evaluated separately from a drug product and 2. Active APIs with an approval notification that were registered after 2017 and are evaluated independently or together with a drug product.
Once the announcement takes place, there will be a 1-year transition period. Once this transition period ends, all active API DMF holders must submit their renewal application to the CDE at least 6 months before their original registration expires. If the registration has already expired, it will need to be renewed within 1 year of the implementation of this announcement. If API manufacturers fail to comply with this new regulation, they may risk having their API DMF canceled by the NMPA.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.