NMPA Clarifies Four Priority Review Scenarios for Chemical APIs, Effective August 1, 2026

News Release – July 11, 2026

On July 1, 2026, the National Medical Products Administration (NMPA) issued the Announcement on Matters Relating to the Application of the Priority Review and Approval Procedure for Marketing Authorization to Chemical Active Pharmaceutical Ingredients (No. 25 of 2026). The announcement specifies four categories of chemical API marketing authorization applications eligible for the priority review and approval procedure, effective August 1, 2026.

The four eligible scenarios are:

1. Chemical APIs used in connection with drug formulations that have already been included in the priority review and approval procedure under the Working Procedure for Priority Review and Approval of Marketing Authorization of Drugs (Trial) — such APIs are directly included by the CDE upon review;

2. Chemical API varieties used in formulations already approved for marketing in China but currently having only overseas manufacturing sources, where the first domestic manufacturer applies for marketing authorization and requests independent review and approval;

3. Overseas-manufactured chemical APIs currently supplied for the production of originator formulations already approved for marketing in China, where the applicant applies for import marketing authorization or transfer to domestic manufacturing, and requests independent review and approval; and

4. Chemical API varieties identified by relevant State Council departments as being in market shortage.

Notably, for scenarios 2 and 3, applicants are no longer required to submit a separate communication and consultation request. Instead, they may simultaneously submit a priority review application at the time of filing the marketing authorization application, which will then be reviewed and publicised by the CDE in accordance with existing procedures.

As a comprehensive pharmaceutical enterprise covering both API R&D and manufacturing, Loncom Pharma will proactively assess the eligibility conditions for API varieties, shorten review timelines, help improve drug accessibility, and fulfil its corporate mission of "safeguarding human health."