China Introduces a New Regulatory Data Protection and Exclusivity Mechanism

On March 19, 2025, China’s National Medical Products Administration (NMPA) released the Draft Implementing Measures and Working Procedures for Drug Clinical Trial Data Protection (the Draft Measures) for public comment, due by May 18, 2025.¹ The Draft Measures, together with China’s regulatory schemes for patent linkage and market exclusivity, are a significant development in China’s regulatory data exclusivity protection and demonstrate Chinese regulators’ commitment to aligning with international regulatory norms. Once adopted, these measures will provide enhanced regulatory data exclusivity protection for pharmaceutical companies operating in China.

Overview

Although China’s Regulations for the Implementation of the Drug Administration Law included provisions for the protection of drug regulatory data in 2002, implementation has lagged behind, and there was an absence of detailed guidelines.

The proposed regulatory data exclusivity protection under the Draft Measures covers a wide range of medicinal products. Innovative drugs, improved new drugs, and first-to-market generics are eligible for up to six years of regulatory data exclusivity protection after receiving marketing authorization (MA) approval in China. During the regulatory data exclusivity period, the NMPA will not approve follow-on pharmaceutical products that rely on the protected data without the consent of the MA holder (MAH).

Scope of Regulatory Data Exclusivity Protection

The scope of protection includes undisclosed, independently generated clinical trial data filed in support of an MA application. The chart below summarizes the scope of protection for innovative, improved, and generic drugs and biologics. 

Type	Scope of Protection
Innovative chemical drugs and biologics	All unpublished clinical trial data in the MA dossier supporting the drug’s safety, efficacy, and quality control
Improved new chemical drugs and biologics	All unpublished new clinical trial data demonstrating a clear clinical advantage over drugs with known active ingredients or approved biologics	Excluding bioavailability, bioequivalence, and immunogenicity data of vaccines
First-to-market generic drugs or biologics marketed overseas but not marketed in China	All unpublished necessary clinical trial data supporting approval

Regulatory Data Exclusivity Periods

The Draft Measures provide regulatory data exclusivity periods of three to six years for innovative and improved drugs that have not been marketed in China or overseas. For innovative or improved drugs that have been marketed overseas and are seeking MA in China, the regulatory data exclusivity period will be three or six years minus the time difference between the date the drug’s MA application is accepted in China and the date it first obtained MA overseas. As a result, the sooner an overseas innovative or improved drug is introduced to the Chinese market following its initial global launch, the longer its regulatory data exclusivity period will be.

The chart below outlines the regulatory data exclusivity periods for chemical drugs and biologics under China’s drug registration categories.

	Categories	Criteria	Exclusivity Period
Chemical Drugs	Class 1	Innovative drugs not marketed in China or overseas	6 years
	Class 2	Improved new drugs not marketed in China or overseas	3 years
	Class 3	First-to-market generic drugs by domestic applicants referencing originator drugs marketed overseas but not marketed in China	3 years
	Class 4	Generic drugs by domestic applicants referencing originator drugs marketed in China	No exclusivity
	Class 5	Drugs marketed overseas but not marketed in China
	Class 5.1	Innovative drugs marketed overseas seeking MA in China	6 years (China MA application acceptance date - First foreign MA approval grant date)
		Improved new drugs marketed overseas seeking MA in China	3 years (China MA application acceptance date - First foreign MA approval grant date)
	Class 5.2	Generic drugs marketed overseas seeking MA in China	3 years
Preventative Biologics (Vaccines)	Class 1	Innovative vaccines	6 years
	Class 2	Improved vaccines	3 years
	Class 3.1	Vaccines marketed and manufactured overseas but not marketed in China, seeking MA in China	6 years (China MA application acceptance date - First foreign MA approval grant date)
	Class 3.2	Vaccines marketed overseas but not marketed in China, seeking MA and manufacturing in China	3 years
	Class 3.3	Vaccines marketed in China	No exclusivity
Therapeutic Biologics	Class 1	Innovative biologics	6 years
	Class 2	Improved biologics	3 years
	Class 3.1	Biologics marketed and manufactured overseas but not marketed in China, seeking MA in China	6 years (China MA application acceptance date - First foreign MA approval grant date)
	Class 3.2	Biologics marketed overseas but not marketed in China, seeking MA and manufacturing in China	3 years
	Class 3.3	Biosimilars	No exclusivity
	Class 3.4	Other biologics	No exclusivity

Application for Regulatory Data Exclusivity Protection

Applicants must file a regulatory data exclusivity protection application simultaneously with their MA submission. The Center for Drug Evaluation (CDE) of the NMPA will evaluate regulatory data exclusivity protection eligibility, scope, and period as part of the technical review. The CDE will disclose key information for drugs under regulatory data exclusivity protection, including the drug name, approval number, approval date, specifications, MAH, protection period, scope of protection, and expiration date. 

Impact on Other Applicants

During the CDE’s technical review, other applicants may submit objections along with supporting documents. Once regulatory data exclusivity protection is granted, the CDE will neither accept nor approve MA or supplemental applications from other applicants that rely on the protected data. Generic drug applicants may file an MA or supplemental application relying on the protected data only within one year before the regulatory data protection period expires, with approval granted upon the expiration of the originator’s regulatory data exclusivity period. However, applicants who have independently obtained regulatory data or secured the MAH’s consent may submit applications at any time.

Conclusion

Although the Draft Measures establish a framework for regulatory data exclusivity protection in China, they do not address certain issues, such as whether CMC data and pre-clinical data fall within the scope of protection, procedures for challenging data protection applications, and regulatory data exclusivity periods for currently approved drugs that should have been given regulatory data exclusivity protection. Leaving aside the data protection question, it is also debatable whether the NMPA should accept and approve certain applications, such as Class 3 Chemical Drugs, if the applications do not include the full efficacy and safety data contained in the innovator’s application submitted to overseas regulatory agencies. Pharmaceutical companies operating in China should closely monitor the further development of the Draft Measures, submit comments to the NMPA, and take this opportunity to reassess their regulatory strategies for drug development and go-to-market tactics.

If you have any questions about the above topics, please feel free to contact the authors of this Advisory or other members of Arnold & Porter’s Life Sciences teams.

© Arnold & Porter Kaye Scholer LLP 2025 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.