China NMPA Releases Implementation Measures for Drug Trial Data P

On May 15, 2026, China’s National Medical Products Administration (NMPA) released the Implementation Measures for Drug Trial Data Protection (药品试验数据保护实施办法), effective May 15, 2026. The Measures provide equal drug trial data protection terms for domestic and foreign-developed drugs. The data protection scope includes all test data used in the drug marketing authorization application to demonstrate the safety, efficacy, and quality controllability of the drug. During the data protection period, the NMPA will not approve any marketing authorization applications or supplemental applications for improved new drugs, generic chemical drugs, or biosimilars submitted by other applicants without the holder’s consent and relying on the holder’s protected data.

To receive drug trial data protection, drug registration applicants must submit a drug trial data protection application at the same time as submitting their drug registration application. For drug registration applications accepted but not yet reviewed before the date of this announcement, if they meet the conditions for drug trial data protection as stipulated in the Implementation Measures, the applicants should submit an application for drug trial data protection to the Center for Drug Evaluation (CDE) of the NMPA within 15 days from the date of this announcement, along with relevant materials. Specific requirements will be issued separately by the CDE. Failure to submit an application within the deadline will be considered a waiver of drug trial data protection.

A translation of the Implementation Measures follow. The original text is available here (Chinese only). 

Implementation Measures for the Protection of Drug Trial Data

Article 1. This regulation is formulated in accordance with the relevant provisions of the Drug Administration Law of the People’s Republic of China, the Implementing Regulations of the Drug Administration Law of the People’s Republic of China, and the Drug Registration Management Measures, in order to encourage drug innovation and meet the public’s drug needs.

Article 2 The National Medical Products Administration (hereinafter referred to as NMPA) is in charge of the protection of drug trial data (hereinafter referred to as data protection), and shall adhere to the principles of fairness, openness and impartiality, and be responsible for establishing and implementing the data protection system.

The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA ) is responsible for the specific implementation of data protection.

Article 3 Data Protection refers to the protection, by the National Medical Products Administration (NMPA) of the undisclosed experimental data and other data obtained independently by the applicant when eligible chemical drugs and biological products (see attached table) are approved for marketing, for a maximum data protection period of six years. The data protection period is calculated from the date the drug registration application is approved in China.

During the data protection period, if other applicants apply for drug marketing authorization or supplementary applications based on the data mentioned above without the consent of the drug marketing authorization holder (hereinafter referred to as the holder), the National Medical Products Administration shall not grant the authorization; except for other applicants who obtain the data on their own and do not rely on the protected data of others.

During the data protection period, if other applicants submit drug registration applications based on data they have obtained themselves, and the applications meet the requirements, they should be approved, but no data protection period will be granted, and such data shall not be relied upon by subsequent applicants.

In the event of a public health emergency in the country, or when required for the public interest, relevant regulations shall be followed.

Article 4 The undisclosed test data and other data referred to in these Measures refer to the complete, unpublished application data that is used for the first time in China for drug marketing authorization applications.

Article 5. A 6-year data protection period shall be granted from the date of the first domestic marketing authorization of an innovative drug.

For original drugs that are already marketed overseas but not in China, a 6-year data protection period will be granted from the date of the first domestic marketing authorization.

The data protection scope for pharmaceuticals under this clause includes all test data used in the pharmaceutical marketing authorization application to demonstrate the safety, efficacy, and quality controllability of the pharmaceutical product.

For innovative drugs that have been approved for multiple indications but are under the same approval number, data protection is granted for each indication according to the registration category. For newly added indications, the data protection scope is limited to the clinical trial data that supports their market launch.

During the data protection period, the National Medical Products Administration (NMPA) will not approve any marketing authorization applications or supplemental applications for improved new drugs, generic chemical drugs, or biosimilars submitted by other applicants without the holder’s consent and relying on the holder’s protected data; except for applications submitted by other applicants that they obtained themselves and did not rely on protected data from others.

Article 6. A four-year data protection period shall be granted from the date of the first domestic marketing authorization of the improved drug .

For improved drugs that are already marketed overseas but not in China, a 4-year data protection period will be granted from the date of the first domestic marketing authorization.

The data protection scope for pharmaceutical products under this clause includes new clinical trial data demonstrating significant clinical advantages compared to known active ingredient pharmaceutical products (marketed biological products), but excludes data on bioavailability, bioequivalence, and immunogenicity of vaccines.

During the data protection period, the National Medical Products Administration (NMPA) will not approve marketing authorization applications or supplemental applications for generic and biosimilar drugs submitted by other applicants without the holder’s consent and relying on the holder’s protected data; except for applications submitted by other applicants that they obtained themselves and did not rely on protected data from others.

Article 7 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 all test data as required by Article 5, Paragraph 3 of these Measures are submitted to prove the safety, efficacy and quality controllability of the drug, Article 5 of these Measures shall apply, and all test data shall be granted a 6-year data protection period.

If the drug subsequently adds indications, Article 6 of these Measures shall apply, and the corresponding data protection scope shall be granted a 4-year data protection period.

Article 8 grants a 3-year data protection period to the first approved generic drugs (including drugs manufactured overseas) and biological products that are marketed overseas but not in China. The data protection period is calculated from the date the generic drug or biological product obtains marketing authorization.

The data protection scope for pharmaceutical products under this clause includes supporting and necessary clinical trial data, but excludes bioavailability, bioequivalence, and immunogenicity data for vaccines.

During the data protection period, the National Medical Products Administration (NMPA) will not approve marketing authorization applications or supplemental applications for generic and biosimilar drugs submitted by other applicants without the holder’s consent and relying on the holder’s protected data ; except for applications submitted by other applicants that they obtained themselves and did not rely on protected data from others.

Article 9 If an applicant intends to apply for data protection, it shall submit a data protection application at the same time as submitting the application for drug marketing authorization. If there are any questions about data protection, the applicant may apply for communication and exchange.

Article 10 When conducting technical review of drug registration applications, the Center for Drug Evaluation shall, in accordance with the provisions of these Measures, determine the scope and duration of data protection.

Article 11 For drugs that meet the data protection requirements, the National Medical Products Administration will mark the data protection information of the drug in the drug approval certificate.

The Center for Drug Evaluation has established a data protection section on its website to publish relevant information on drug data protection.

Article 12 After a drug obtains data protection, other applicants may submit drug marketing applications and supplemental applications that rely on the protected data within one year before the expiration of the data protection period. The Center for Drug Evaluation will suspend the review time after completing the technical review and approve the relevant drug for marketing after the expiration of the data protection period.

If an applicant claims that the data was obtained independently when submitting a drug marketing authorization application or supplemental application, but it is found during the technical review process that the application relies on protected data from other applicants, the application will not be approved.

Article 13. Data protection shall terminate if the drug approval certificate is revoked, suspended, or cancelled, if the holder voluntarily waives data protection, or if other circumstances stipulated by laws and regulations apply.

Upon termination of data protection, the National Medical Products Administration (NMPA) will issue a termination notice, and the Center for Drug Evaluation (CDE) will update the relevant information in the data protection section according to the notice. From the date the NMPA issues the termination notice, it may accept or approve drug registration applications submitted by other applicants that rely on the protected data.

Article 14 The specific procedures for data protection shall be formulated separately by the Center for Drug Evaluation.

Article 15 This regulation shall come into effect on May 15, 2026 .

Appendix 1

Chemical Drug Registration Classification and Data Protection Period

Appendix 2

Registration classification and data protection period for preventive biological products

Appendix 3

Registration classification and data protection period for therapeutic biological products