On May 15, 2026, China’s National Medical Products Administration (NMPA) officially announced the final Measures for the Implementation of Drug Trial Data Protection1 (“Measures”), effective May 15, 2026.
These Measures provide important details supporting the recently announced Implementing Regulations of the Drug Administration Law (“Regulations” – also effective May 15, 2026), which formally introduced a statutory market exclusivity of up to 7 years for qualifying orphan drugs, up to 2 years for pediatric drugs, and up to 6 years data exclusivity for “new chemical entity drugs and other drugs”.
Key Highlights
Under the finalized Measures, the NMPA2 grants a maximum regulatory data protection (“RDP”) period of up to 6 years from the date of a drug’s marketing authorization in China. During this protection window, the NMPA will not approve subsequent marketing authorization applications for generics, biosimilars, or modified drugs that rely on the original drug marketing authorization holder’s (MAH) “undisclosed experimental data and other data” without the MAH’s consent.
During the RDP period other applicants can submit drug marketing applications based on their own obtained data, but such data will not receive RDP protection and cannot be used by other following applicants.
What Data is Protected?
The protected “undisclosed test data and other data” refers to unpublished data (including partially-published data) used for the first time in China in a marketing authorization application. For innovative drugs, this includes data that demonstrate the safety, efficacy, and quality controllability of the drug. For improved innovative drugs, the protection includes all supporting and necessary clinical trial data showing clinical advantages of the improved drug over the original innovative drug, with the exception of bioavailability, bioequivalence, and immunogenicity data for vaccines.
The data protection periods are summarized below (full charts at the end of this article):
|
Type of Product |
Class |
RDP Period |
|
Innovative Drugs, Vaccines, and Biologics |
Class 1 |
6 years |
|
Improved Innovative Drugs, Vaccines, and Biologics |
Class 2 |
4 years |
|
The first approved domestic generic drug/biosimilar of an originator drug marketed overseas but not yet in China |
Class 3.2 / 5.2 |
3 years |
Some Notable Observations
Removal of “Penalty” for Drugs Entering China Later: The 2025 draft included a restrictive penalty for drugs approved overseas before entering China, proposing that the protection period be reduced by the time difference between the overseas MA approval date and the China MA acceptance date. The final 2026 Measures completely removes this deduction formula, treating innovative and improved innovative drugs, vaccines, and biologics equally, regardless of whether they were first approved elsewhere.
Extended Data Protection for Improved Innovative Drugs: Compared to the 2025 draft, data protection period for Improved Innovative Drugs has increased from 3 years to 4 years.
Broadened Definition of “Self-Obtained” Data: In its official policy interpretation, the NMPA clarified that “self-obtained” data does not require the applicant to have physically conducted the clinical trials themselves. Data acquired through commercial purchases or exclusive licensing agreements also qualify for data protection, creating additional value for such data.
Clarification on “Undisclosed” Status: The NMPA clarified that mandatory global clinical trial registrations or summary abstract disclosures do not compromise the required “undisclosed” status of the protected data under these Measures, provided the comprehensive, underlying raw trial data remain confidential.
Timeline for Generic Entry: Generic applicants can submit filings relying on the protected data starting 1 year before the exclusivity expires. The NMPA will complete its technical review, pause the application process, and release the final marketing authorization immediately after the data protection period ends.
Subsequent Generics: To improve drug accessibility, once a “first generic” of an overseas original drug is approved (gaining a 3-year protection period), subsequent generic applicants do not need to duplicate clinical safety and efficacy trials if the first generic has already been listed on the domestic market for 2 years.
EIP Thoughts:
We are pleased to see that the final Implementation Measures have removed any reductions for RDP, providing the same data protection for all new drugs regardless of whether they obtained MA outside of China first. This was an important issue for many foreign drug companies, and we are encouraged that the NMPA appears to have taken into account feedback3 it received following the Draft Measures to arrive at this final version. These finalized Regulations and Measures will certainly encourage even more foreign companies to consider entering China.
China’s RDP policy allows a single drug to potentially receive data protection separately for each new indication. However, the protection scope for a new indication is limited to the clinical trial data used to support the launch of the new indication.
The NMPA explained that “the core purpose of RDP is to protect original trial data generated to prove a drug’s safety and efficacy.” Therefore, new data protection for a drug can be granted only if the newly generated data was essential for evaluating a drug or vaccine’s safety and efficacy (e.g., in the new indication). This principle applies equally to new combination therapies, as well as for bioavailability, bioequivalence, and vaccine immunogenicity data.
Interesting, in China PTE (patent term extension due to regulatory delay) is only available to Innovative Drugs (Class 1) and certain Improved Innovative Drugs (Class 2) that have not yet been marketed in China. Additionally, one can only receive one PTE per drug, one PTE per patent. Drug companies should consider RDP strategy carefully in conjunction with a drug’s overall patent strategy, especially when multiple indications may exist. This is especially true in China, where certain patent decisions (e.g., when to file divisional applications) need to be made relatively early in a patent’s prosecution lifetime. Drug companies will need to consider various aspects of how to map out a product’s patent, clinical, PTE, RDP, and market entry strategies to optimize the overall protection of a drug product.
One Important Deadline
Applicants must formally submit their data protection request to the Center for Drug Evaluation (CDE) of the NMPA simultaneously with their initial marketing authorization application. Companies who already have approved drugs in China or pending marketing applications submitted prior to May 15, 2026 must submit their data protection requests within 15 working days of the announcement, i.e no later than June 5, 2026.
Chemical Drug Registration Classification and Data Protection Period
|
Class |
Drug |
Data protection period |
Remark |
|
Class 1 |
Innovative Drugs that have not been marketed in China or overseas |
6 years | |
|
Class 2 |
Modified (or “improved”) Innovative Drugs that have not been marketed in China or overseas |
4 years |
For Innovative Drugs that are already marketed overseas but not in China, if a registration application for a new indication that has not been approved in either China or overseas is submitted for the first time, and meets the requirements of Article 7, Paragraph 1 of these Measures, the data protection period is 6 years. |
|
Class 3 |
Drugs manufactured by domestic applicants that are Generics of Innovative Drugs that have been marketed overseas but not in China |
3 years |
The first drug of its kind to be approved in China |
|
Class 4 |
Drugs manufactured by domestic applicants that are Generics of Innovative Drugs that have been marketed in China |
None |
No data protection |
|
Class 5 |
Drugs that have been marketed overseas and are under application for marketing in China | ||
|
5.1 |
Innovative Drugs that are already marketed overseas but not in China |
6 years |
If the conditions in Article 7, Paragraph 2 are met, the data protection period is 4 years. |
|
Modified (or “improved”) Innovative Drugs that are already marketed overseas but not in China |
4 years | ||
|
5.2 |
Generic Drugs that are already marketed overseas but not in China |
3 years |
The first drug of its kind to be approved in China; or a generic version of an innovative drug that is already on the market overseas but not in China. |
Vaccines Registration Classification and Data Protection Period
|
Class |
Drug |
Data protection period |
Remark |
|
Class 1 |
Innovative Vaccines |
6 years | |
|
Class 2 |
Modified (or “improved”) Innovative Vaccines |
4 years | |
|
Class 3 |
3.1 Vaccines manufactured overseas that are already marketed overseas but not in China |
6 years | |
|
3.2 Vaccines that are already marketed overseas but not in China and are submitted for approval for manufacturing and marketing in China. |
3 years | ||
|
3.3 Vaccines that already marketed in China |
None |
No data protection |
Biologic Drugs Registration Classification and Data Protection Period
|
Class |
Drug |
Data protection period |
Remark |
|
Class 1 |
Innovative biological products |
6 years | |
|
Class 2 |
Modified (or “improved”) Innovative drugs |
4 years |
For original drugs that are already marketed overseas but not in China, if a registration application for a new indication that has not been approved in either China or overseas is submitted for the first time, and meets the requirements of Article 7, Paragraph 1 of these Measures, the data protection period shall be 6 years. |
|
Class 3 |
3.1 Biological products manufactured overseas that are already marketed overseas but not in China |
6 years |
For cases meeting the criteria in Article 7, Paragraph 2, the data protection period is 4 years. For non-innovative drugs, the data protection period is 3 years. |
|
3.2 Biological products that are already marketed overseas but not in China and are submitted for approval for manufacturing and marketing in China. |
3 years | ||
|
3.3 Biosimilars |
None |
No data protection | |
|
3.4 Other biological products |
None |
No data protection |
If you would like to have more information on this matter or would like to have our advice, please feel free to contact us at eip@eipgroup.asia.
This article is for general informational purposes only and should not be considered legal advice or a legal opinion on a specific set of facts.
About the Authors
Jennifer Che, J.D. is President & Managing Director and a US Patent Attorney at Eagle IP, a boutique patent firm with offices in Hong Kong and Shenzhen.
Yolanda Wang is a Principal, Chinese Patent Attorney, and Chinese Patent Litigator at Eagle IP, a boutique patent firm with offices in Hong Kong and Shenzhen.
药品试验数据保护实施办法 Sources: official announcement and follow up notice (Chinese)
↩︎The Center for Drug Evaluation (CDE) of the NMPA will oversee the granting of RDP.
↩︎Many organizations, including the American Intellectual Property Law Association (AIPLA), Intellectual Property Owners Association (IPO), and other organizations representing the interests of foreign drug companies provided Comments in response to the Draft Measures released in March 2025. Eagle IP worked with many other attorneys on the IP Practice in China Committee of AIPLA to submit Comments on behalf of AIPLA to the NMPA about these concerns.
↩︎
