On May 15, 2026, the National Medical Products Administration officially released the “Implementation Measures for the Protection of Drug Trial Data” (hereinafter referred to as the “Implementation Measures”), which will come into effect on the day of release.

As early as 2002, the Implementation Regulations of the Drug Administration Law had put forward the principle requirements for the protection of drug trial data, but detailed rules have not been introduced yet. The release of the “Implementation Measures” this time is a key measure to implement the “Drug Administration Law” and its implementation regulations, filling the institutional gap in the specialized protection of drug trial data in China, and marking the further integration of the pharmaceutical intellectual property protection system with international standards.

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1、 What is drug trial data protection?

Simply put, data protection refers to the protection provided by the National Medical Products Administration to the self obtained and undisclosed experimental and other data submitted by applicants when eligible chemical drugs and biological products are approved for market, with a maximum data protection period of no more than 6 years. The data protection period shall be calculated from the date of approval of the drug registration application in China.

Key pints of core rules:

During the data protection period, if other applicants rely on the data mentioned in the preceding paragraph to apply for drug marketing authorization or supplementary applications without the consent of the holder of the drug marketing authorization, the National Medical Products Administration will not grant permission; Except for other applicants who obtain protected data on their own without relying on others.

During the data protection period, if other applicants submit self obtained data application for drug registration, those who meet the conditions shall be approved, but no data protection period shall be granted, and the data shall not be relied upon by other applicants in the future.

Protected data refers to the initial, undisclosed, and complete application data for drug marketing authorization within the country.

2、 Which drugs are eligible for data protection? How long will it be protected?

The scope and duration of data protection may vary depending on the registration classification of the drug. The current rules in our country have set differentiated data protection periods for drugs with different levels of innovation. The specific classification and corresponding protection periods are as follows:

The protection period starts from the date when the drug is approved for market in China and lasts for a maximum of 6 years. It runs independently of patent protection and data protection can still take effect after the patent expires
6-year protection period (highest level): Innovative drugs (Chemical Class 1, Biological Class 1) that have not been marketed domestically or internationally, and original research drugs (Chemical Class 3, Biological Class 3) that have been marketed domestically but not domestically;
4-year protection period: Improved new drugs (chemical class 2, biological class 2) that have not been marketed domestically or internationally, and original research drugs of overseas improved drugs that have been marketed domestically;
3-year protection period: The first approved overseas generic drug (first generic drug) that has already been marketed but has not yet been marketed domestically, limited to newly obtained clinical data.

Attention: During the data protection period, other applicants who rely on the protected data of the holder to submit marketing applications or supplementary applications for improved new drugs, chemical generic drugs, and biosimilars will not be granted permission by the National Medical Products Administration; Except for other applicants who submit to obtain protected data on their own without relying on others.

3、 Three major institutional breakthroughs in the Implementation Measures

（1） Cancel the ‘calculation formula’ and substantially extend the protection period of overseas drugs
Compared to the previous draft for soliciting opinions, the official version has cancelled the complex data protection period calculation formula for drugs that are “listed overseas and not listed domestically” (originally planned to deduct the time difference between domestic and foreign listings), and directly applies the complete protection periods of 6 years and 4 years uniformly. The significant extension of the data protection period for overseas innovative drugs reflects the policy orientation of encouraging them to enter the Chinese market as early as possible.

（2） Clarify the standards of “self acquisition” and “dependence”
The Implementation Measures specify that the data must be obtained by the applicant on their own (including self research, commissioned research, purchase, or exclusive authorization), and “undisclosed” refers to the incomplete disclosure of the entire data, and partial disclosure does not affect the integrity of the data.
Dependency “refers to the use of original drug data or references to apply for the marketing of improved or generic drugs, without repeating the same trials. This definition provides a clear judgment basis for subsequent law enforcement.
（3） Transferring drugs produced overseas to China can continue data protection
The Implementation Measures stipulate that if the original research drugs that have obtained data protection overseas are transferred to domestic production, during the original data protection period, if other applicants rely on the data without the consent of the domestic holder, the drug regulatory authority will not grant permission. This measure provides institutional guarantees for the “real estate” of overseas original research drugs and encourages multinational pharmaceutical companies to transfer production to China.

4、 The significance for pharmaceutical companies

（1） First generic drug enterprise: challenges and opportunities coexist

For first-time imitators, the data protection period of the original drug constitutes a clear market barrier, and companies cannot rely on the original data to directly apply for listing during the protection period. But at the same time, the system also provides a 3-year data protection period for the first approved generic drug, and the first listed company can prevent other generic drugs from relying on its data declaration within 3 years.

Special attention should be paid to drugs that have been marketed overseas but not domestically, even if they do not have a patent in China or the patent has expired, they can still receive a 6-year data protection period after their first approval. Therefore, the first imitation enterprise needs to establish dual monitoring: on the one hand, tracking the original research data protection period and laying out the application in advance; On the other hand, evaluate the development costs and first imitation benefits of varieties without patents but with data protection, in order to seize market opportunities.

（2） Improved new drug companies: Data protection provides a more solid barrier for secondary development

For enterprises engaged in the development of improved new drugs, data protection provides a more stable protection tool than patents. Although new indications, crystal forms, and dosage forms of known active ingredients can be patented, patent claims are easily evaded and the cost of safeguarding rights is high. And data protection directly locks in the clinical trial data that supports drug approval. As long as generic drug companies cannot complete trials to prove clinical advantages on their own, they cannot be approved for marketing. Therefore, enterprises should attach importance to secondary development, build data assets through high-quality clinical trials, and construct stronger market barriers.

（3） Innovative pharmaceutical companies: Data protection is the ‘second line of defense’ beyond patents

For innovative pharmaceutical companies, data protection provides a bottom line guarantee for R&D investment. Patents for innovative drugs may become invalid due to invalidity, writing defects, or design avoidance, but data protection does not rely on patent validity. Once a drug is approved for marketing, it automatically receives a protection period of up to 6 years. Enterprises should incorporate data protection into their overall intellectual property strategy, plan data generation strategies in the early stages of research and development, ensure the integrity and compliance of clinical trial data, and maximize the value of data protection.

5. Conclusion
The official implementation of the “Implementation Measures for the Protection of Drug Trial Data” fills the institutional gap in the protection of innovation in China’s biopharmaceutical industry, marking a new stage in the dual track parallel development of “patent protection+data protection” in China’s pharmaceutical intellectual property system. Unlike the technical protection logic of the patent system, drug data protection focuses on clinical trial data and builds an independent, stable, and bottom-up market-oriented protection barrier for pharmaceutical innovation, effectively solving the industry pain points of high investment in pharmaceutical research and development, weak innovation returns, and easy replication of achievements.
As a professional service organization deeply involved in the field of biopharmaceutical intellectual property, Zhizhongde Ben has long focused on providing full chain practical services such as pharmaceutical patent layout, compliance risk control, innovation rights protection, and data protection rule implementation. Based on rich practical experience in pharmaceutical intellectual property, the team can assist innovative pharmaceutical companies, improved drug companies, and generic drug companies in accurately matching data protection application conditions, seizing window periods for application, and building dual innovation protection barriers of “patent+data”, helping companies maximize the preservation of innovation achievements, consolidate market competitive advantages, and enjoy the benefits of new policies in compliance.

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