Author |  James Ma  

On May 15, 2026, the National Medical Products Administration issued and implemented the "Measures for the Implementation of Drug Test Data Protection" (the "Implementation Measures"). The Center for Drug Evaluation of the NMPA also simultaneously released the supporting document "Work Procedures for the Protection of Drug Test Data".

Data protection refers to that the NMPA will provide protection for the unpublicized and self-acquired test data and other data submitted by applicants for the qualified chemical drugs and biological products when the drugs are approved for market launch, and the data protection period is up to six years. The protection period begins from the date the drug registration application is approved domestically.

According to the innovative level of the drug, the Implementation Measures provide different data protection periods for drug test data; The data protection period system does not cover generic drugs and biosimilars.

1、 Protection Period of drug test data

According to the Implementation Measures, for eligible drug test data, from the date of drug registration:

       i.         For drug test data of innovative drugs and originator drugs: the data protection period is 6 years;

     ii.         For drug test data of improved new drugs: the data protection period is 4 years;

    iii.         For the drug test data of the first generic: the data protection period is 3 years.

During the data protection period, if other applicants rely on the protected data to apply for drug marketing approval without the consent of the holder, the NMPA will not accept or grant approval.

2、 Scope of Protection for Drug Test Data

According to Article 5 of the Implementation Measures, the scope of drug test data includes "all test data used to prove the safety, efficacy, and quality controllability of drugs. Drug test data mainly refers to the following test data:

   i.     Pharmaceutical data, including but not limited to raw material/formulation research, production processes, quality standards and methodology research, stability research, packaging compatibility research, etc.

  ii.   Nonclinical research data, including but not limited to pharmacological studies, pharmacokinetic studies, toxicological studies, safety pharmacology studies, etc.

   iii.    Clinical research data, early clinical (phase I/II) data, key clinical (phase III) data, etc.

3、 The Implementation Measures have removed the system of reducing the protection period of drugs that have been listed overseas but not domestically from the Draft for public opinions

In the Draft of the Implementation Measures for public opinions, for the originator drugs that have been listed overseas but not domestically, it provided that "for originator drugs that have been listed overseas but not domestically and apply for listing in China, the data protection period is 6 years minus the time difference between the date of acceptance of the application for marketing approval submitted by the drug in China and the date of the drug's first overseas marketing approval." The original intention of this provision is to encourage overseas listed drugs to enter the Chinese market as soon as possible.

The drug protection period reduction system in the Draft of the Implementation Measures has attracted great attention and discussion from domestic and foreign pharmaceutical companies. In the final approved Implementation Measures, the deduction system was removed and a 6-year data protection period was also granted.

4、 The drug test data protection system has further improved the drug patent linkage system

Finally, the purpose of the drug test data protection system is to protect the undisclosed original data on safety, efficacy, and quality controllability obtained by pharmaceutical companies through significant investment, prevent free riding behavior in the process of applying for drug registration, and enable pharmaceutical companies to receive effective returns for their investment on innovation and research and development.

With the implementation of China's drug test data protection system, it, together with the drug patent protection system, further improves China's drug patent linkage system. This will provide institutional guarantees for innovative drugs in China and encourage foreign innovative drugs to enter China as soon as possible.

Click the link below to view the NMPA's official announcement and the full text of the "Measures for the Implementation of Pharmaceutical Test Data Protection".

https://drive.google.com/file/d/1joqp8E_WHltHI3-uEvGgcvSh2Wljgg3i/view