NMPA Issues New "Chemical Drug Registration Acceptance Review Guidelines" to Standardize Drug Registration Process

On March 10, 2025, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) implemented the newly released Guidelines for the Acceptance Review of Chemical Drug Registration (Trial). This update introduces stricter electronic submission requirements, expanded clinical trial exemptions, and heightened compliance obligations, directly impacting the registration strategies of international pharmaceutical companies. Businesses planning to enter or already operating in China’s pharmaceutical market must align their documentation, patent declarations, and submission formats with the new requirements to avoid delays or non-compliance.

Core Content of the New Guidelines: Clearer Classification Management and Standardized Electronic Submission

The New Guidelines are divided into two main parts, each targeting different registration categories of chemical drugs:

• Part One: Applicable to Category 1 (new drugs not marketed in or outside China), Category 2 (improved new drugs), and Category 5.1 (new indications for original drugs already marketed outside China);
• Part Two: Covers Category 3 (generic drugs marketed in China), Category 4 (generic drugs with reference preparations already in China), and Category 5.2 (generic drugs produced outside China).

Key changes include:

1. Comprehensive Strengthening of Electronic Submission: It is explicitly required to submit applications in eCTD (electronic Common Technical Document) or electronic format. All PDF files must be stamped with an electronic seal and support online transmission.
2. Patent Declaration and Infringement Liability: Generic drug marketing applications must declare the patent status in accordance with the China Listed Drug Patent Information Registration Platform and commit to liability for infringement.
3. Refinement of Reference Preparation Requirements: It is emphasized that the development of generic drugs must be based on the national "Directory of Reference Preparations for Generic Drugs". Varieties transferred from overseas to domestic production must be registered as generic drugs.
4. Expansion of Clinical Trial Exemptions: Eligible generic drugs and over-the-counter drugs can directly submit marketing applications, reducing R&D costs.

Key Focus for International Companies: Increased Compliance Barriers and Tight Time Window

For international manufacturers, the implementation of the New Guidelines means higher compliance requirements and stricter review standards:

• Increased complexity in document preparation: Proof of legal sources for active pharmaceutical ingredients (APIs), excipients, and packaging materials must be provided. Foreign documents must meet the requirements of an Apostille.
• Patent risks need to be avoided in advance: Generic drug companies must systematically assess the risk of patent infringement and complete the declaration before submitting the application.
• Proof of production compliance: Foreign production enterprises must submit proof of compliance with GMP. If not yet obtained, a declaration can be used temporarily, but it must be submitted before the end of the evaluation. Countdown to implementation date: Companies must complete the transition from the old to the new guidelines before March 10, 2025. In particular, registration applications in preparation must adjust the format and content of the submission documents according to the new requirements.

Recommendations for Response: Seizing the Initiative and Leveraging Professional Services

To efficiently respond to the new regulations, international companies can adopt the following strategies:

• Internal Review and Training: Quickly organize the team to study the new guidelines, focusing on the electronic submission process, patent declaration requirements, and reference preparation selection criteria.
• Partner Selection: Collaborate with local CROs (Contract Research Organizations) or consulting firms familiar with Chinese regulations to ensure document compliance.
• Early Layout of Electronic Capabilities: Invest in eCTD system construction and optimize internal document management processes to avoid delays in evaluation due to format issues.

Further Information

To read the original NMPA announcement about new guidelines for chemical drug registration, please click here. If you are a pharmacuetical manufacturer with questions about chemical drug registration, please contact Cisema.

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