In follow up to the May 15, 2026 release of the Implementation Measures for the Measures for Drug Trial Data Protection (药品试验数据保护实施办法), China’s National Medical Products Administration also released an Interpretation of the same. The Interpretation provides more details the Measures, such as what is test data used to prove the safety, efficacy and quality controllability of drugs and is new clinical trial data protected for conditionally approved drugs.
A translation follows. The original text is available here (Chinese only).
I. How should we understand the terms “undisclosed,” “obtained independently,” and “dependent” as stipulated in the “Implementation Measures”?
Undisclosed: With the development of the industry and the need to protect the public’s right to know, drug regulatory agencies in major countries and regions around the world generally require the public disclosure of information such as summaries or reports of clinical trial results. The undisclosed nature stipulated in these Implementation Measures refers to the incomplete disclosure of relevant trial data; that is, if only a portion of the trial data is disclosed, the overall trial data is still considered undisclosed.
Self-obtained: This includes drug trial data obtained by the drug registration applicant through self-conducted research, commissioned research, or by purchasing or obtaining exclusive authorization.
Dependency: Typically, new drug approval requires complete data from pharmaceutical, non-clinical, and clinical trials. However, improved new drugs and generic drugs use the original drug as a reference. They generally do not need to repeat clinical trials; instead, they supplement the evidence of safety and efficacy with clinical advantages by comparing the drug to the original, or indirectly demonstrate pharmaceutical consistency and efficacy equivalence with the original drug through bioequivalence (BE) trials.
The reliance stipulated in these Implementation Measures refers to situations where other applicants cite or refer to test data proving the safety and efficacy of the original drug to apply for marketing authorization for improved new drugs or generic drugs, without repeating the same test.
II. Why is traditional Chinese medicine not subject to data protection regulations?
Traditional Chinese medicine shall be handled in accordance with the “Regulations on the Protection of Traditional Chinese Medicine Varieties” and its supporting documents.
III. What does “all test data used to prove the safety, efficacy and quality controllability of drugs” include in Article 5 of the “Implementation Measures”?
According to the “Drug Registration Management Measures” and ICH guidelines, test data used to demonstrate the safety, efficacy, and quality controllability of drugs basically cover the following categories:
(a) Pharmaceutical data, including but not limited to research on active pharmaceutical ingredients/formulations, manufacturing processes, quality standards and methodologies, stability studies, and packaging material compatibility studies.
(ii) Non-clinical research data, including but not limited to pharmacodynamic studies, pharmacokinetic studies, toxicological studies, and safety pharmacology studies.
(iii) Clinical research data, including early clinical (Phase I/II) data and pivotal clinical (Phase III) data.
IV. Should new data protection be granted for drugs that have already obtained data protection, including new indications, new patient populations, or combined use? Should data on bioavailability, bioequivalence, and immunogenicity of vaccines be granted data protection?
The core of drug trial data protection is the protection of original trial data generated to demonstrate the safety and efficacy of drugs. Therefore, only when new data proving the safety and efficacy of drugs is generated can new data protection be granted.
For drugs that have already obtained data protection, if new original clinical trial data can be provided when adding new indications or patient populations, this part of the clinical trial data can be protected; however, new combination therapy regimens need to be evaluated on a case-by-case basis, and data protection may only be obtained when completely new data is required.
Because clinical data related to bioavailability and bioequivalence have not generated new evidence of safety and efficacy, they are not covered by data protection.
Given that the purpose of data protection is to encourage drug innovation, clinical trials of protective efficacy are the gold standard for evaluating innovative vaccines, and immunogenicity is a surrogate endpoint for evaluating vaccine effectiveness, it is not protected.
V. If the active ingredient of a drug is already marketed overseas but not in China, but the new indication for which it is first applied for marketing in China is not marketed either in China or overseas, how can the trial data be protected in this case?
For original drugs already marketed overseas but not in China, if the initial indication for which a marketing application is submitted in China has not been approved for marketing either domestically or internationally, although they are classified as improved new drugs in drug registration, the applicant must submit not only clinical trial data related to that indication, but also all trial data used to demonstrate the drug’s safety, efficacy, and quality controllability. In other words, the data requirements for such drug registration applications are consistent with those for innovative drugs and original drugs already marketed overseas but not in China. To encourage simultaneous domestic and international research and development of new indications, and considering the basic principles of data protection for drug trials, the “Implementation Measures” stipulate that in this situation, Article 5 of the “Implementation Measures” should apply, granting six years of data protection. The scope of data protection includes all trial data in the drug marketing authorization application materials used to demonstrate the drug’s safety, efficacy, and quality controllability.
However, for drugs that subsequently add indications, they only need to submit the data required for the approval of the new indication. There is no difference between them and other applications for new indications. Therefore, Article 6 of the Implementation Measures applies to grant four years of data protection. The scope includes new clinical trial data that proves that the drug has significant clinical advantages compared with known active ingredient drugs (marketed biological products), but does not include bioavailability, bioequivalence, or immunogenicity data of vaccines.
VI. If the production of drugs manufactured overseas is transferred to China, can the original data protection period for drugs manufactured overseas be extended?
Yes. To improve drug accessibility and meet clinical needs, foreign companies are encouraged to transfer the production of original drugs marketed in China to China. If the original drug has obtained data protection for its trials, during the data protection period, the National Medical Products Administration (NMPA) will not grant marketing authorization or supplementary applications to other applicants relying on data from imported or domestically produced original drugs without the holder’s consent. The aforementioned holders include holders of imported and domestically produced original drugs. Holders of domestically produced drugs must obtain the consent of the original drug holder to obtain the aforementioned protection.
VII. For conditionally approved drugs that have obtained data protection, will new clinical trial data generated after market launch be granted new data protection?
Conditionally approved drugs that meet the data protection requirements already have a data protection period at the time of approval. New clinical trial data obtained from post-marketing studies conducted to fulfill the conditions for approval of a conditionally approved drug is supplementary evidence of the previous approval conclusions and does not constitute new evidence of clinical safety or efficacy; therefore, no new data protection period is granted. However, during the data protection period of this drug, other applicants may not obtain marketing authorization based on this new clinical trial data without the holder’s consent.
VIII. How should the data protection period be handled for Class 5.1, Class 5.2, and Class 3 chemical drugs?
To encourage the early entry of original drugs already marketed overseas into China and meet the clinical needs of Chinese patients, after the data protection period is granted for Class 5.1 chemical drugs, the data protection period for Class 5.2 and Class 3 chemical drugs that have already obtained data protection will remain valid. For Class 5.2 and Class 3 chemical drugs that have already been accepted, those that meet the requirements will continue to be reviewed and approved, but no further data protection period will be granted. For new drug marketing registration applications and supplementary applications that rely on this data, the provisions of Article 12 of the Implementation Measures shall apply.
IX. After the release of the “Implementation Measures”, how should the management requirements for clinical trials of generic drugs of the same type that are already on the market overseas but not on the market in China be optimized and adjusted?
Article 8 of the Implementation Measures defines “the first approved generic version of an original drug that is already marketed overseas but not yet marketed domestically” as the first generic version of the same drug to be approved. For generic versions of original drugs that were already marketed overseas but not yet marketed domestically before the Implementation Measures were issued, other newly submitted applications for the same generic version do not need to repeat the safety and efficacy clinical trials after the first one has been marketed for two years.
