Announcement No. 129 of 2023 was released by the National Medical Products Administration (NMPA) on October 13, 2023, focusing on the renewal of licenses for Active Pharmaceutical Ingredients (APIs), referred to as API re-registration.
The highlight of this update is the renewal of API licenses shall be ready at least SIX months before the old one expires, otherwise it will hinder the export to China.
The original regulation is as follows:
“On October 13, 2023, the National Medical Products Administration (NMPA) issued Announcement No. 129 of 2023, addressing the renewal of licenses for Active Pharmaceutical Ingredients (APIs), which is also known as API re-registration. These requirements aim to enhance the order in the API market and ensure public drug safety.
1. Requirements and Procedures for API License Renewal
According to the announcement, Chinese domestic API registration applicants must be the actual manufacturers, while foreign manufacturers should appoint Chinese legal entities for registration. Chinese domestic manufacturers renew licenses through provincial Medical Products Administrations (MPAs), and foreign manufacturers apply to the Drug Evaluation Center (CDE) of NMPA.
1.1. Timeline for License Renewal
Applicants should request renewal six months before the drug approval number or API approval expires.
Approval leads to a renewed license, while non-approval results in a rejection notice. For license holders with approvals expiring in less than six months or already expired, there is a transitional period for renewal within one year from the date of this announcement.
APIs not registered on the API, Excipient, and Packaging Material Registration Platform (AEP platform) must align their renewal with associated drugs upon approval.
1.2. License Renewal Outcomes
Results of license renewal include:
- Approval maintains the “Active” DMF status on the AEP platform.
- Non-approval or late renewal changes DMF status from “A” to “I” and revokes the approval, marked as “Revoked” on the AEP platform. Applicants can re-apply for registration following the “Announcement of the State Medical Products Administration on Further Improving the Work Related to the Review, Approval, and Supervision of Drug-Related Reviews” (NMPA No. 56 of 2019), providing a new registration number.
- If applicants meet renewal deadlines but haven’t completed the review before licenses expire, the API registration information notes “License Renewal Review in Progress.”
1.3. Cancellation Requests
Applicants voluntarily applying to cancel API approval license can submit a written request. Foreign API manufacturers can directly submit a written letter to the CDE for cancellation.
2. Issuance of API Approval Notifications
This announcement also details the “issuance of approval notifications” for APIs. After successful API registrations through either associated reviews or standalone reviews, approval notifications will be issued, including approved production processes, quality standards, and labels as the attachments. The validity period is five years from the approval date. Supplementary applications receive supplementary application approval notifications for successful reviews.
3. Interpreting the Announcement’s Core Requirements and Significance
In conjunction with this announcement, the NMPA has provided an interpretation emphasizing the importance of verifying production capacity, ensuring compliance with quality management within specified regulatory timelines, summarizing production, sales, sampling, changes, and other relevant information by implementing the API license renewal policy. These actions are crucial for local oversight of API responsibilities and reinforcing the main responsibilities of API manufacturers. This fosters API industry development and upholds drug quality and safety.
In conclusion, the NMPA’s announcement refines API management, clarifies renewal requirements and procedures, and reinforces manufacturer responsibilities. These measures prioritize public drug safety and support the growth of the API industry.”
Accestra Consulting as an independent regulatory affairs agent supporting with China’s Drug Master File (DMF), we will provide comprehensive guidance and support to ensure compliance and successful DMF registration.
If you need to renew your API DMF license or for any questions, please contact us or email info@accestra.com