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Protection of Drug Trial Data on 15 May 2026 with immediate effect, i.e. simultaneously with the Implementing Regulations of the Drug Administration Law (2026 Revisions). The enforcement of the official Measures brings China’s pharmaceutical intellectual property protection into a new dual-track era of patent and data protection.
The final measures confirm that data protection (data exclusivity) is prescribed for innovative drugs, improved new drugs, and generic drugs per the Applicant’s request and with respect to the self-obtained and undisclosed trial data and other data submitted by the Applicant.
During the data protection period
- if other applicants apply for drug marketing authorisation or supplementary application relying on the same data without the consent of the drug marketing authorisation holder, the National Medical Products Administration will not grant it
- if other applicants submit drug registration applications using data obtained by themselves, their applications shall be approved if they meet the requirements but no longer be granted the data protection period.
The request for data protection shall be submitted at the same time as submitting the application for drug marketing authorisation.
We have provided data exclusivity summary tables below this article as a guide for different product types.
How the final measures differ from the recent Draft
Further to our previous article on the 2025 Draft Measures that were issued in March, the official measures have introduced significant changes, which mainly include:
- Removal of subtraction mechanism
The official Measures remove the draft’s “time-gap reduction” rule, awarding full data protection terms to innovative drugs and improved new drugs that have been first marked overseas upon their first China approval. This is a major advantage for multinational pharmaceutical enterprises, facilitating the earlier and more extensive launch of their new drugs in China.
- Increased protection period for improved new drugs
In the official Measures, the protection period for improved new drugs is extended from three years in the 2025 Draft to four years and thus encourages incremental innovations. R&D outcomes achieved via improvements in dosage forms, administration routes and indications shall be under market protection.
- Protection rules for new indications of original drugs
The office Measures provide 6-year data exclusivity for the first indication that has not been approved overseas or in China for an original drug that has been marked overseas but not in China. This new rule offers clear institutional incentives for the secondary development of oversea marketed medicinal products.
Data protection regimes for different products
The detailed data protection regimes stipulated in the official Measures are summarised as follows.
- For innovative drugs
A 6-year data exclusivity is granted for an innovative drug that has not been marketed in China from the date of their first China marketing authorisation. This include the original drugs that have been marked oversea but not in China.
The scopes of drug data protection cover all the test data used in the drug marketing authorisation application materials to prove the safety, efficacy and quality controllability of the drug.
For innovation drugs that have been approved for multiple indications but have the same approval number, each indication will be given data protection according to the registration category, and the scope of data protection for newly added indications will be the clinical trial data that support its marketing.
- For improved new drugs
A 4-year data exclusivity will be granted for improved new drugs, including those having been marketed overseas but not in China, from the date of the first China marketing authorisation.
The scopes of drug data protection cover new clinical trial data that demonstrates that the drug has significant clinical advantages over drugs with known active ingredients (marketed biological products), but does not cover data for bioavailability, data for bioequivalence or immunogenicity data of vaccines.
- For Generic Drugs
A 3-year data exclusivity is granted to the first approved generic drugs (including drugs manufactured overseas) and biological products that have been marketed overseas but not in China. The data exclusivity is calculated starting from the date on which the generic drug or biological product obtains marketing authorisation.
The scopes of data protection for drugs cover necessary clinical trial data that support marketing approval, but does not cover data for bioavailability, data for bioequivalence or immunogenicity data of vaccines.
- For new indications of original drugs
For an original drug that has been marked overseas but not in China, a 6-year data exclusivity is granted for a new indication of the original drug that has not been approved overseas or in China, based on all trial data on safety, efficacy and quality controllability.
For additional indications subsequently applied for the same original drug, a 4-year data exclusivity shall be granted.
- Retrospective Measures: 15-day time window
For marketing applications approved or accepted before the issuance of the official measures and yet pending review, MAH or the applicants can file data protection applications within 15 days, i.e. by 30 May 2026. Pharmaceutical enterprises shall act promptly to avoid forfeiture of relevant rights.
Looking forward
Compared with the previous drafted measures, the effective new regime may be a welcome development for overseas pharmaceutical companies, as China poises to introduce a considerably more generous data exclusivity framework for original drugs, drugs with new indications, and improved new drugs that are marketed in China for the first time.
The 6-year data exclusivity period, when combined with patent protection, could effectively extend the overall exclusivity available to innovative drugs. This dual-track protection mechanism is expected to significantly improve the anticipated return on investment for pharmaceutical companies introducing innovative drugs into the Chinese market.
Accordingly, pharmaceutical companies should develop coordinated patent and data protection strategies: securing early-stage R&D outcomes through patent protection while preserving post-launch market exclusivity through data protection. By doing so, they can maximise the benefits of the dual protection framework.
Summary tables
The following summary tables provide details of data exclusivity for the corresponding drug categories according to NMPA.
Table 1 | Chemical Drugs
| NMPA Classification | Contents | Data exclusivity | Notes |
|---|---|---|---|
| Category 1 | Innovative drugs that have not been marketed in China or overseas | 6 years | |
| Category 2 | Improved new drugs that have not been marketed in China or overseas | 4 years | 6 years for a new indication that has not been approved in China or overseas for an original drug that has been marketed overseas but not in China |
| Category 3 | Generic drugs by domestic applicants while the corresponding original drugs have been marketed overseas but not marketed in China | 3 years | |
| Category 4 | Generic drugs by domestic applicants while the corresponding original drugs have been marketed in China | – | No data exclusivity shall be granted. |
| Category 5 | Drugs that have been marketed overseas apply for marketing approval in China | ||
| Category 5.1 | Original drugs that have been marketed overseas apply for marketing approval in China | 6 years | 4 years for additional indications filed after the first new indication |
| Improved new drugs that have been marketed overseas apply for marketing approval in China | 4 years | ||
| Category 5.2 | Generic drugs that have been marketed overseas but not in China apply for marketing approval in China | 3 years | |
Table 2 | Preventive biological products
| NMPA Classification | Contents | Data exclusivity | Notes |
|---|---|---|---|
| Category 1 | Innovative vaccines | 6 years | |
| Category 2 | Improved vaccines | 4 years | |
| Category 3 | 3.1 Vaccines that have been manufactured and marketed overseas but not marketed in China apply for marketing approval in China | 6 years | |
| 3.2 Vaccines that have been marketed overseas but not marketed in China apply for manufacturing and marketing approval in China | 3 years | ||
| 3.3 Vaccine that have been marketed in China | – | No data exclusivity shall be granted. |
Table 3 | Therapeutic biological products
| NMPA Classification | Contents | Data exclusivity | Notes |
|---|---|---|---|
| Category 1 | Innovative biological products | 6 years | |
| Category 2 | Improved biological products | 4 years | 6 years for a new indication that has not been approved in China or overseas for an original drug that has been marketed overseas but not in China |
| Category 3 | 3.1 Biological products that have been manufactured and marketed overseas but not marketed in China apply for marketing approval in China | 6 years | 4 years for additional indications filed after the first new indication. 3 years for non-original drugs. |
| 3.2 Biological products that have been marketed overseas but not marketed in China apply for manufacturing and marketing approval in China | 3 years | ||
| 3.3 Biosimilars | – | No data exclusivity shall be granted. | |
| 3.4 Other biological products | – | No data exclusivity shall be granted. |