The National Medical Products Administration (NMPA) has issued Announcement No. 25 of 2026, systematically clarifying the official rules for the priority review and approval procedures for chemical active pharmaceutical ingredients (APIs) for the first time. The new policy will come into force on August 1, 2026.

This initiative establishes a dedicated expedited review pathway for chemical APIs, accelerating product launch, facilitating import substitution, ensuring the supply of clinical medications, and providing clear regulatory guidance for API registration applications. Previously, priority review policies mainly focused on finished drug products. This new rule fills the regulatory gap for APIs, realizes coordinated acceleration for both finished drugs and supporting APIs, and effectively addresses core industry pain points including unstable supply chains, excessive import reliance, and clinical drug shortages.

I. Four Eligible Scenarios for API Priority Review

A marketing authorization application for chemical APIs is eligible for priority review if it meets any of the following criteria:

1. APIs Supporting Priority-Review Finished Products

APIs matched with finished drug products that have been included in the priority review program are eligible for synchronous priority review, avoiding delays in finished product launch caused by slow API review progress.

2. First Domestic Generic APIs with Exclusive Overseas Supply

For APIs currently supplied exclusively by overseas manufacturers for domestic finished drug production, the first domestic enterprise applying for independent marketing review and approval qualifies for priority review, encouraging domestic production substitution.

3. Imported or Locally Transferred APIs for Original Drug Production

Overseas APIs continuously used for the production of domestically marketed original drugs, for which enterprises apply for import marketing or domestic production capacity transfer with independent review requirements, to stabilize the supply chain of original branded drugs.

4. APIs Certified as Nationally Shortage Products

The first marketing application for chemical APIs confirmed as in market shortage by relevant national authorities will be directly included in the priority review pathway to guarantee the supply of clinically urgent medications.

II. Streamlined Application Procedures to Reduce Compliance Costs

The new policy simplifies application formalities for all eligible scenarios, eliminating unnecessary pre-submission consultations and significantly improving review efficiency:

• Nationally designated shortage APIs: The first submitted application with official shortage certification from competent authorities will be directly admitted to the expedited review pathway.

III. Core Policy Benefits

1. Greatly Accelerated Review Timeline: Compared with the standard 200-day review period for common APIs, the review cycle for priority-review APIs is shortened to130 days, enabling faster market entry.

2. Enhanced Supply Chain Security: The policy encourages import substitution and localized production, mitigating supply chain risks and resolving API shortage and import dependency issues.

3. Industrial Upgrading Guidance: It guides enterprises to focus on R&D of high-value, shortage-essential and innovation-supported APIs, reducing homogeneous low-end competition in the industry.

IV. Key Reminders

 ▓Effective Date: August 1, 2026. Enterprises may start sorting out product pipelines and preparing application dossiers in advance.

☞Scope of Application: Applicable exclusively to marketing authorization applications for chemical APIs, subject to independent review or finished drug-associated review requirements.

☺Core Advantages: Simplified procedures, prioritized regulatory resources, shortened review cycle and accelerated commercialization.

Our institution continues to provide professional full-process drug registration services, including product eligibility evaluation, dossier guidance and application progress follow-up. We support the rapid approval and launch of high-quality APIs, empowering high-quality pharmaceutical industry development and ensuring stable supply of clinical medications.

Please feel free to contact us for any inquiries regarding registration applications!