Article 1  These Measures are formulated in accordance with 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, the Provisions for Drug Registration, and other relevant laws and regulations, for the purpose of encouraging drug innovation and meeting the public's needs for drugs.

Article 2  The National Medical Products Administration (hereinafter referred to as the NMPA) is in charge of drug regulatory data protection (hereinafter referred to as "data protection"). Adhering to the principles of fairness, openness, and impartiality, the NMPA is responsible for establishing the data protection system and overseeing its implementation.

The Center for Drug Evaluation of the NMPA (hereinafter referred to as the CDE) is responsible for the specific implementation of data protection.

Article 3  Data protection refers to the protection granted by the NMPA to the undisclosed trial data and other data submitted that were obtained by the applicant on its own, upon the approval for marketing of eligible chemical drugs and biological products (see the Appendix for details), with a data protection period of no more than 6 years. The data protection period shall be calculated from the date the drug registration application is approved within the territory.

During the data protection period, if other applicants file applications for drug marketing authorization or supplementary applications by relying on the data referred to in the preceding paragraph without the consent of the marketing authorization holder (hereinafter referred to as the "MAH"), the NMPA shall not grant such authorization; except where other applicants who have obtained the data on their own without relying on the protected data of others.

During the data protection period, if other applicants submit a drug registration application using self-obtained data, such applications shall be approved if eligible; however, no data protection period shall be granted, and such data may not be relied upon by other subsequent applicants.

In the event of a public health emergency in China, or where required for the public interest, matters shall be handled in accordance with relevant provisions.

Article 4  The undisclosed trial data and other data referred to in these Measures refer to unpublished, complete submission data used for the first time within the territory for a drug marketing authorization application.

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

For originator drugs that have been marketed overseas but not yet marketed within the territory, a six-year data protection period shall be granted from the date of the first domestic marketing authorization.

The scope of data protection for drugs under this provision includes all regulatory data in the drug marketing authorization application materials used to demonstrate the drug's safety, efficacy, and quality control.

For innovative drugs that have successively obtained approval for multiple indications but share the same approval number, data protection shall be granted separately for each indication according to its registration category; the scope of data protection for newly added indications shall be the clinical trial data supporting their marketing authorization.

During the data protection period, the NMPA shall not grant approval for marketing applications or supplementary applications for modified new drugs, generic chemical drugs, and biosimilars submitted by other applicants that rely on the protected data of the MAH without the MAH's consent; this does not apply to applications submitted by other applicants based on self-obtained data without relying on the protected data of others.

Article 6  A data protection period of 4 years shall be granted from the date of the first domestic marketing authorization for a modified new drug.

For modified new drugs that are already marketed overseas but not yet marketed within the territory, a 4-year data protection period shall be granted from the date of the first domestic marketing authorization.

The scope of data protection for drugs under this provision includes new clinical trial data demonstrating significant clinical advantages over drugs with known active ingredients (marketed biological products), but excludes data on bioavailability, bioequivalence, and vaccine immunogenicity data.

During the data protection period, the NMPA shall not grant approval for marketing applications or supplementary applications for generic chemical drugs and biosimilars submitted by other applicants that rely on the MAH's protected data without the MAH's consent; except where other applicants based on self-obtained data without relying on protected data of others.

Article 7  For an originator drug that is already marketed overseas but not yet marketed within the territory, where a registration application for a new indication not yet approved either within the territory or overseas is submitted for the first time, and all regulatory data specified in the third paragraph of Article 5 of these Measures to demonstrate the drug's safety, efficacy, and quality control are submitted, the provisions of Article 5 of these Measures shall apply, and a 6-year data protection period shall be granted for all regulatory data.

If subsequent indications are added for such a drug, Article 6 of these Measures shall apply, and a 4-year data protection period shall be granted for the data within the corresponding scope of protection.

Article 8  Generic drugs (including drugs manufactured overseas) and biological products that are the first to be approved for an originator drug which is already marketed overseas but not yet marketed within the territory, and which are the first to be approved, shall be granted a 3-year data protection period, calculated from the date on which the generic drug or biological product obtains a marketing authorization.

The scope of data protection for drugs under this provision includes necessary clinical trial data supporting approval, but excludes bioavailability, bioequivalence, and immunogenicity data for vaccines.

During the data protection period, the NMPA shall not grant approval for applications or supplementary applications for generic chemical drugs or biosimilars submitted by other applicants that rely on the MAH's protected data without the MAH's consent; this exclusion does not apply to applications submitted by other applicants based on data they have obtained independently without relying on another party's protected data.

Article 9  An applicant intending to apply for data protection shall submit the application for data protection concurrently with the application for a drug marketing authorization. If there are any questions regarding data protection, the applicant may request a communication.

Article 10  When conducting technical review of drug registration applications, the CDE will determine the scope and duration of data protection in accordance with the provisions of these Measures.

Article 11  For drugs that meet the conditions for data protection, the NMPA shall indicate the data protection information for such drugs in the drug approval certificate.

The CDE shall establish a dedicated section on data protection on its website to publish relevant information regarding drug regulatory data protection.

Article 12  After a drug obtains data protection, other applicants may submit marketing applications and supplementary applications relying on such protected data within one year prior to the expiration of the data protection period. Upon completion of the technical review by the CDE, the review clock shall be suspended, and the relevant drug shall be approved for marketing after the expiration of the data protection period.

If an applicant claims that the data were self-obtained when submitting a drug marketing application or a supplementary application, but it is discovered during the technical review process that the application relies on another applicant's protected data, the application shall not be approved.

Article 13  Data protection shall terminate if the drug approval certificate is revoked, withdrawn, or canceled; if the MAH voluntarily waives data protection; or in other circumstances prescribed by laws and regulations.

Upon termination of data protection, the NMPA shall issue an announcement regarding the termination of data protection, and the CDE shall update the relevant information in the dedicated data protection section in accordance with the announcement. From the date on which the NMPA issues the announcement regarding the termination of data protection, drug registration applications submitted by other applicants that rely on such protected data may be accepted or approved.

Article 14  The specific working procedures for data protection shall be formulated separately by the CDE.

Article 15  These Measures shall come into effect on May 15, 2026.