The National Medical Products Administration (NMPA) of China has released a draft proposal for the “Notice on Issuing the Domestic Produced Drugs Re-registration Application Procedures and Application Materials Requirements.” The public is invited to provide feedback from May 13 to June 12.
According to the draft notice, Marketing Authorization Holders (MAHs) of domestically produced drugs and chemical raw material drug manufacturers must submit a drug re-registration application via the NMPA’s official service portal. They are required to generate a drug re-registration application form between 12 and 6 months prior to the expiration of the validity period of the drug approval certificate documents and submit the necessary application materials in the prescribed format. If an application for drug re-registration is not submitted within six months before the certificate’s validity period expires, or if there are interruptions such as suspension of acceptance or review and approval, production must not continue after the certificate’s expiration.
The provincial bureau is mandated to conduct a formal review of the drug re-registration application form and materials within five working days. If the application or materials are deficient, the applicant must be notified of all necessary corrections within five days. The applicant then has 30 days to complete the supplementary materials. If the application still fails to meet the requirements after correction, it will not be accepted.
The drug re-registration review and approval process is capped at 120 days. The provincial bureau must complete the review within 100 days after acceptance and the approval within 20 days after the review. Within ten days of completing the approval, the “Notice of Approval for Drug/Chemical Raw Material Re-registration” and the “Notice of Non Re-registration of Drug/Chemical Raw Material” will be issued, with relevant information updated simultaneously on the NMPA’s website.- Flcube.com
