On July 1, the National Medical Products Administration (NMPA) issued the Announcement on Matters Concerning the Application of the Priority Review and Approval Procedure for Drug Marketing Authorization to Chemical Active Pharmaceutical Ingredients (No. 25 of 2026), effective August 1, 2026.
According to the Announcement, when applying for marketing authorization of a chemical active pharmaceutical ingredient (API), the applicant may request the priority review and approval procedure if the application falls under any of the following four categories:
| Category | Specific Conditions | Application Method |
|---|---|---|
| 1 | Chemical APIs used in connection with drug formulations already included in the priority review and approval program | Directly included by the Center for Drug Evaluation (CDE); no separate application required from the enterprise |
| 2 | Varieties that have been used in approved formulations in China but are only available from overseas manufacturers, and for which the first domestic manufacturing application is submitted for marketing authorization with a request for independent review and approval | Priority review request may be submitted simultaneously with the marketing authorization application; no prior communication or consultation required |
| 3 | Overseas-manufactured chemical APIs currently supplying the domestic production of originator preparations, for which an import marketing application or a transfer-to-domestic manufacturing application is submitted with a request for independent review and approval | Same as Category 2 |
| 4 | Varieties identified by the relevant departments of the State Council as market-shortage products | Upon receipt of a written recommendation, the CDE will directly include the first pending or newly submitted application for that variety |
Regarding the application process, Categories 1 and 4 are directly included by the CDE, requiring no additional application from the registrant. For Categories 2 and 3, the registrant may submit the priority review request simultaneously with the marketing authorization application, with no need for prior communication.
Under current regulations, the standard review and approval timeline for chemical APIs in China is 200 working days, while the priority review and approval timeline is 130 working days—a reduction of approximately 70 working days for eligible companies through the priority channel.
This marks the first time that the NMPA has extended the priority review pathway to the chemical API stage, following the earlier implementation of the priority review system for drug formulations.
