The Center for Drug Evaluation under the National Medical Products Administration (NMPA) has issued the “Requirements for Application Materials for Market Registration of Listed Drugs Produced Abroad and Transferred to Domestic Production (Preventive Biological Products),” which is set to take effect immediately. This new directive pertains to preventive biological products, specifically vaccines utilized for human immunization to prevent and control the incidence and spread of diseases.
For vaccines that are produced overseas and already listed in China, wishing to transition to domestic production, the domestic applicant must submit a registration application for market listing in accordance with the regulations governing Category 3.3 preventive biological products. It is fundamentally required that the quality management system controls both the transferees and production plants before and after the transfer, ensuring a unified quality management system.
The guidelines stipulate that drugs produced overseas are not permitted to be transferred multiple times to various holders for production within China through this pathway. Additionally, different specifications of the same drug should be transferred to the same domestic applicant to maintain consistency and regulatory compliance.- Flcube.com
