On 15 May 2026, the National Medical Products Administration of the People’s Republic of China (NMPA) issued Announcement No. 47 of 2026, whereby the Measures for the Implementation of Drug Trial Data Protection (the “Implementation Measures”) officially came into effect[1]. This signifies the formal establishment and implementation of the drug trial data protection regime in China. This data protection regime covers chemical drugs and biological products, and grants different protection periods and scopes based on the degree of drug innovation, thereby comprehensively incentivizing the development of innovative drugs while taking into account the interests of generic drugs. The key points of the Implementation Measures are summarized as follows.
1. The subject matter of data protection is undisclosed trial data and other data independently obtained by the applicant. Such trial data shall be unpublished, complete registration data that are used for the first time within the territory of China for a drug marketing authorization application.
2. Different protection periods and scopes are granted for different categories of drug marketing authorization applications. Specifically:
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For innovative drugs and original research drugs that have been marketed overseas but not yet marketed domestically (including chemical drugs, vaccines and therapeutic biological products) that are applying for marketing authorization for the first time within the territory of China, a 6‑year data protection period shall be granted, and the scope of protection shall cover all trial data in the marketing authorization dossier used to demonstrate the safety, efficacy and quality controllability of the drug.
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For original research drugs (including chemical drugs and therapeutic biological products) that have been marketed overseas but not yet marketed domestically, where a new indication that has not been approved either domestically or overseas is submitted for the first time, a 6‑year data protection period may be obtained; however, where other indications have already been approved earlier or additional new indications are subsequently added, only a 4‑year protection period shall be granted. The scope of protection is limited to the clinical trial data supporting the marketing of the new indication.
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For improved drugs (including chemical drugs, vaccines and therapeutic biological products), a 4‑year data protection period shall be granted, and the scope of data protection shall include only new clinical trial data that demonstrate an obvious clinical advantage compared with known active ingredients (marketed biological products), excluding bioavailability, bioequivalence and immunogenicity data of vaccines.
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For generic drugs and biological products of the first approved original research drug that has been marketed overseas but not yet marketed domestically, a 3‑year data protection period shall be granted, and the scope of protection shall include only the necessary clinical trial data supporting the approval, excluding bioavailability, bioequivalence and immunogenicity data of vaccines.
3. During the data protection period, where another marketing authorization applicant relies on the protected trial data to submit a marketing authorization application without the permission of the right holder, the NMPA shall not grant approval. For trial data of innovative/original research drugs, applications for improved new drugs, chemical generics and biosimilars shall all be refused approval; for trial data of other types of drugs, only chemical generics and biosimilars that rely on such trial data shall be refused approval.
4. Applications for trial data protection shall be submitted concurrently with the drug marketing authorization application. For drug registration applications that were submitted prior to 15 May but have not yet completed the review process, an application for drug trial data protection shall be submitted within 15 days; failure to submit within the time limit shall be deemed a waiver of drug trial data protection.
5. The Center for Drug Evaluation of the NMPA shall be responsible for the technical review of data protection, determining the scope and duration of data protection to be granted, and publishing relevant information on data protection.
6. Within one year prior to the expiry of the data protection period, a drug marketing authorization application relying on such trial data may be submitted, and upon completion of the technical review, the relevant drug shall be approved for marketing after the expiry of the data protection period.
The implementation of the drug trial data protection regime undoubtedly provides more comprehensive protection and a longer period of market exclusivity for innovative drugs in addition to the patent protection regime, thereby attracting more breakthrough and clinically superior innovative drugs into the Chinese market and providing Chinese patients with a broader range of therapeutic options. At the same time, it also encourages the earliest possible market entry of first generics, which can likewise enjoy a certain period of market exclusivity, thereby increasing the accessibility of blockbuster drugs and achieving a balanced and mutually reinforcing environment for both generics and innovation, fostering a prosperous market where both can advance in parallel.
