China NMPA Expands Priority Review for Chemical API Marketing Authorization Applications

On July 1, 2026, China's National Medical Products Administration (NMPA) issued the "Notice on Matters Related to the Priority Review and Approval Procedures Applicable to Chemical Active Pharmaceutical Ingredient Marketing Authorization Applications" (Announcement No. 25 of 2026), extending the applicability of the agency's existing priority review and approval procedures to eligible chemical active pharmaceutical ingredient (API) marketing authorization applications.

Effective August 1, 2026, the notice expands the scope of China's existing priority review framework by defining the categories of standalone chemical API marketing authorization applications that may apply for, or be directly included in, the existing priority review process.

China Expands Priority Review to Chemical APIs

Rather than introducing a new expedited program, the NMPA has expanded the scope of its existing "Priority Review and Approval Procedure for Drug Marketing Authorization" to cover four categories of chemical API applications:

• APIs Supporting Priority Review Products: Chemical APIs used in finished drug products that have already been accepted into the NMPA priority review and approval process.
• First Domestic API Applications: The first domestically manufactured chemical API, previously available only from overseas, for use in a drug product already approved for marketing in China, where separate API review and approval is sought.
• Manufacturing Transfer Applications: Chemical APIs manufactured overseas for approved originator products where separate marketing authorization is sought either for import into China or following transfer of manufacturing to domestic production.
• Shortage-Related APIs: Chemical APIs identified by relevant State Council departments as being in market shortage.

This announcement provides long-awaited clarity on the eligibility of standalone API applications, allowing companies to better integrate regulatory opportunities into their development and lifecycle planning.

Streamlined Entry into Priority Review

In addition to defining eligibility, the notice simplifies how qualifying API applications enter the priority review process.

Direct Request

Applicants seeking priority review for first domestic API registrations and eligible manufacturing transfer applications no longer need to submit a separate communication request before filing. Instead, where the published eligibility criteria are met, applicants may request priority review at the time they submit the API marketing authorization application under the existing priority review procedures.

This procedural change removes an administrative step that applicants previously would have needed to complete before filing.

Direct Inclusion for Certain Applications

Where a chemical API supports a finished drug product that has already entered priority review, the NMPA Center for Drug Evaluation (CDE) will review whether the API application meets the applicable requirements and, if so, include it directly in the priority review process.

Similarly, for APIs identified by relevant State Council departments as being in market shortage, the CDE may directly include the first qualifying chemical API marketing authorization application under review after receiving the required written recommendation from the relevant State Council department and completing its review.

Strategic Considerations for Global Pharmaceutical Companies

For multinational pharmaceutical companies, API manufacturers, and CDMOs, the announcement is less about changing manufacturing strategy than about expanding the regulatory tools available when planning product registrations, lifecycle management, or manufacturing changes in China.

Companies with planned or active chemical API registrations should assess whether any applications fall within the newly defined eligibility criteria before the policy takes effect on August 1.

Priority actions include:

• Screen upcoming China API filings for priority review eligibility before submission strategy is finalized 
• Coordinate API and finished drug submission sequencing where linked applications may qualify under the priority review framework
• Review lifecycle management and manufacturing transfer programs to determine whether they satisfy the newly defined eligibility categories
• Update regulatory timelines and launch assumptions for programs likely to receive priority review

Final Thoughts

Announcement No. 25 introduces a more structured, criteria-based system for API filings, replacing discretionary uncertainty with predictable administrative pathways. For global firms, the value of this policy lies in its ability to convert regulatory intent into actionable timelines. Successfully navigating this framework requires nuanced foresight — particularly in mapping how API submissions interface with finished drug approvals and evolving state-level shortage designations.

Bridging the gap between complex regulatory mandates and your commercial objectives requires specialized local expertise. Cisema identifies exactly where your portfolio intersects with these priority pathways, allowing you to leverage administrative efficiencies to protect your launch timelines and maintain operational continuity.

For support with NMPA regulatory affairs and strategy across the full approval process, contact Cisema today.

Further Information

• Explore Cisema’s pharmaceutical consulting services

References

• Notice from the National Medical Products Administration on Matters Related to the Priority Review and Approval Work Procedures for Marketing Authorization of Drugs Applicable to Chemical Active Pharmaceutical Ingredients (2026 No. 25)