China Releases Comprehensive Draft Data Exclusivity Rules for Comments

 * This article was co-authored with Olivia Zhao from Bird & Bird Lawjay Shanghai association team. 

On 19 March 2025, the National Medical Products Administration (the “NMPA”) published the “Interim Implementation Regulations for Drug Trial Data Exclusivity (Draft for Comments)” (the “Draft Data Exclusivity Regulations”) and the “Work Procedures for Drug Trial Data Exclusivity (Draft for Comments)” (the “Draft Data Exclusivity Work Procedures”).

The public consultation closes on 18 May 2025. The Draft Regulations and Work Procedures and NMPA’s official drafting notes can be found at NMPA official website.

1.  Highlights 

• The proposed data exclusivity protection covers new chemical drugs, biologics, improved new chemical drugs and biologics, new drugs approved abroad but not in China, and first approved generic drugs or biologics.
• The scope of the data exclusivity will cover undisclosed, independently generated trial data filed in support of a marketing authorization (“MA”) application. During the exclusivity term, competitors cannot rely on the protected data without MA holder (“MAH”)’s consent. 
• Exclusivity is limited to unpublished trial data in the original MA dossier that is used for the first time in China to support a MA application and exclude post-approval studies. 
• The scope and terms of exclusivity follow the national treatment principle under the TRIPS Agreement and align with China’s 2019 Implementing Regulations of Drug Administration Law and 2007 Drug Registration Rules.
• The Center for Drug Evaluation (the “CDE”) of the NMPA will review eligibility and determine the scope and term of exclusivity, which will be recorded in the MA approval and published on a dedicated NMPA website. 

2.  Exclusivity Terms 

2.1.  NCEs and innovative biologics

• Exclusivity: 6 years for NCEs and biologics which have not been approved in China or abroad, commencing from the date of first MA approval grant in China. For originator drugs approved abroad but not in China, the term of exclusivity is:

6 years - (China MA application acceptance date - First foreign MA approval grant date)

• Scope of protection: All unpublished clinical trial data in the MA dossier supporting the drug’s safety, efficacy, and quality control. If additional indications are later approved under the same MA, the unpublished clinical trial data supporting each new indication may qualify for its own exclusivity period.

2.2.  Improved new drugs and improved biologics

• Exclusivity: 3 years for improved new drugs and biologics, not previously approved in China or abroad, commencing from the date of first MA approval grant in China. For improved new drugs approved abroad but not in China, the term of exclusivity is:

3 years - (China MA application acceptance date - First foreign MA approval grant date)

• Scope of protection: All unpublished new clinical trial data demonstrating a clear clinical advantage over drugs with known active ingredients or approved biologics but excludes bioavailability and bioequivalence (“BA/BE”) study data, and immunogenicity data for vaccines.

2.3.  First approved generic drugs or biologics

• Exclusivity: 3 years for the first approved generic drugs (including drug manufactured abroad) or biologics that reference originator drugs approved abroad but not in China, commencing from the date of MA approval grant in China.
• Scope of protection: All unpublished necessary clinical trial data supporting approval.

3.  Exclusivity Terms by Drug Classification 

According to Appendix 1-3 of the Draft Data Exclusivity Regulations, the respective exclusivity terms are as follows:

Chemical drugs

Preventive biologics (vaccines) 

Therapeutic biologics

4.  Submission and Review Process

• Exclusivity application and review: Request for data exclusivity protection must be submitted with the MA application. The CDE will evaluate exclusivity eligibility, scope, and term as part of the technical review.
• Competitor application and review: Competitors relying on protected data without MAH’s consent may submit MA application within one year before the exclusivity expiration. The CDE will conduct the technical review and place the review timeline on hold until the exclusivity expiration. For competitors obtaining MAH’s consent, a signed “Drug Trial Data Consent Agreement” (Appendix 2 of the Draft Data Exclusivity Work Procedures) must be submitted, affirming that any disputes concerning data authorization will not interfere NMPA’s review and approval process. 
• Required documentation: 

-  Application Form (Appendix 1 of the Draft Data Exclusivity Work Procedures), setting out detail of exclusivity term, scope, and basis.

-  For drugs approved abroad seeking approval in China, evidence of the first foreign MA date is required.

-  Applicants must bear responsibility for ensuring the truthfulness of all submitted documentation.

• Consultation and dispute resolution: Applicants may consult the CDE before or during the review process to accelerate the review and approval. Unresolved issues or disputes are first reviewed by the CDE technical committee, and if necessary, escalated to the NMPA for final resolution. 
• Previously accepted MA applications: MA applications accepted by the CDE before the implementation of the new data exclusivity provisions will not be granted exclusivity terms.

China’s draft data exclusivity rules introduce a long-awaited structured and transparent framework to protect regulatory data which aligns with global regulatory norms and reflects China’s objective to become the global player for innovative and global drugs. For multinational companies, the first-approved, first-protected model underscores the importance of early and strategic regulatory planning in China.