The National Medical Products Administration (NMPA) has issued a notification outlining the requirements for the refiling procedures and materials for domestically produced drugs, which will come into effect on January 1, 2025. The document mandates that marketing authorization holders (MAHs) of these drugs and registrants of chemical raw materials must visit the NMPA’s online service hall to submit a refiling application along with the relevant documents within 12 to 6 months prior to the expiration of the drug approval certificate.
According to the guidelines, the provincial medical products administration department is required to conduct a formal review of the application materials within 5 working days. If the application does not meet the requirements, a notice of correction must be issued within 5 days, and the applicant must complete the correction materials within 30 days. Applications that still fail to meet the requirements after correction will not be accepted. The drug refiling review and approval process is given a time limit of 120 days, with the provincial medical products administration department expected to complete the review within 100 days after acceptance and the approval within 20 days after the review is completed. A notice of approval or refusal to refile must be delivered within 10 days from the date of completion of self-approval.
The validity period of the drug refiling approval notice will be calculated from the day after the expiration of the original drug approval certificate document. If the original drug approval certificate is approved for refiling after the expiration of its validity period, the validity period will be calculated from the date of approval for refiling by the provincial medical products administration department.- Flcube.com
