On 15 May 2026, the National Medical Products Administration (NMPA) issued the Implementation Measures for Drug Trial Data Protection (the Measures), which came into effect on the same date. The Measures sit alongside the Drug Administration Law1, its implementing Regulations2 and the Drug Registration Measures3, and provide standalone, specific rules for regulatory data protection in China.
The Measures represent a significant step in aligning China's regulatory framework with international standards, while also reflecting unique domestic priorities. For pharmaceutical and biotech companies, this directly affects when competitors can rely on existing trial packages instead of running their own studies, and how originators can use trial data as part of their overall exclusivity strategy in China.
In essence, the Measures set out (i) when and how trial data submitted in support of marketing authorisations are protected from reliance by later applicants, and (ii) an innovative approach to the periods of protection which varies across three categories of data.
From a historical development perspective, China published its first draft on regulatory data protection measures for public comment in 20184, followed with the second draft in 20255. The final Measures now place this regime on a clear footing, using a tiered approach that distinguishes different categories and grants different protection periods to each category. Compared with earlier drafts, the final Measures extend protection for improved new drugs from three to four years, but do not retain the special regimes for orphan and paediatric drugs.
1. Tiered protection periods
The Measures build a tiered structure, offering three different terms of protection in correspondence with the following NMPA registration categories. The protection runs from the date the product first obtains marketing authorisation in China.
- Six years – for innovative and certain originator products
- Innovative drugs not previously marketed in China or overseas (Category 1 chemical drugs biological products);
- Overseas-marketed originators first launched in China (certain Category 5.1 chemical drugs and Category 3.1 biological products);
- Globally novel new indications for overseas-marketed originators (certain Category 2.4 chemical drugs and Category 2.2 biological products).
- Four years – for improved new drugs
- Improved new drugs not yet marketed in China or overseas (certain Category 2 chemical drugs biological products6);
- Certain improved products already marketed overseas and then brought into China (certain Category 5.1 chemical drugs and Category 3.1 biological products).
- Three years – for the first generic in China
- First-approved generics of originators that are marketed overseas but not yet in China (certain Category 3 and Category 5.2 chemical drugs and Category 3.2 biological products).
This tiered approach is broadly consistent with international practice, but the specific categories and protection periods reflect China's regulatory priorities.
2. Scope of protected data and key protection rules
The Measures also lay out protection to the following types of data respectively under the above-mentioned categories:
- For innovative and originator products: all relevant pharmacological, non-clinical and clinical trial data in the application dossier.
- For improved new drugs: new clinical data showing a clear clinical advantage over products with known active ingredients or marketed biologics.
- For first generics: the necessary clinical data supporting marketing approval.
In all cases, bioavailability data, bioequivalence data and vaccine immunogenicity data are excluded from protection.
For each of these protectable data, the Measures create a "no approval" plus "no acceptance" protection:
- NMPA will not approve marketing or supplementary applications from other applicants that rely on the protected data, unless with the consent of the marketing authorisation holder.
- NMPA will not accept applications that rely on the protected data until one year before the end of the protection period. Applications filed in that final year may still be accepted and reviewed, yet no approval will be issued before the expiration of the protection term.
The Measures also provide that regulatory data protection must be requested simultaneously with the marketing authorisation application. Upon grant, the protected data will be indicated on the approval document and published on the website of the NMPA's Center for Drug Evaluation. These procedural requirements enhance transparency and predictability, but companies must plan their applications carefully to avoid inadvertently missing out on protection.
3. What it means for originator and generic companies
The Measures will reshape how the originator and generic companies plan product development and launches in China. Both originator and generic companies will need to adapt their strategies to the new regulatory regime.
For originator companies:
- Positioning data protection alongside patent protection
Regulatory data protection now operates alongside patent protection. Although patents have a longer nominal term. the long R&D and approval timelines for drug products mean that, by the time a product seeks marketing authorisation in China, only a short patent term may remain. In some cases, this may even be shorter than the data protection period under the Measures. In those cases, regulatory data protection can provide an additional layer of protection beyond patent expiry. - Incorporating data protection into collaboration planning
Originator companies may wish to review how rights in clinical trial data are allocated in licensing, co-development and CRO arrangements, alongside traditional IP and commercial terms. Clear provisions on ownership, rights of reference and permitted uses of the data will be important to ensure that the originator can fully benefit from the regulatory data protection.
For generic companies:
- Assessing development targets through a data protection lens
When selecting targets, generic company may need to assess whether the originator is likely to benefit from data protection in China and, if so, when that protection is expected to end, as this will affect if and when reliance on originator data is feasible. - Potential value of being first generic
For originators that are marketed overseas but not yet in China, the first approved generic in China can obtain three years of protection for its own necessary clinical trial data. This may justify targeted investment in filing strategy for selected products.
4. Key takeaways
Overall, the Measures put regulatory data protection firmly on the agenda for companies active in China's life sciences sector. Trial data is now a clearer and more predictable part of the exclusivity landscape, meaning that portfolio selection, clinical development, collaboration and launch planning all need to take the new protection periods into account. Developing an early understanding of how key assets align with the different protection tiers, and how these interact to patents and other rights, will enable industry players to refine their strategies for the China market.
1 The Drug Administration Law of the People's Republic of China (2019 Revision) was issued by the Standing Committee of the National People's Congress on 26 August 2019.
2 The Implementing Regulations of the Drug Administration Law of the People's Republic of China (2026 Revision) was issued by the State Council on 16 January 2026.
3 The Measures for the Administration of Drug Registration (2020 Version) was issued by the State Administration for Market Regulation on 22 January 2020.
4 The Implementation Measures for Drug Trial Data Protection (Interim) (Draft for Comments) was issued by the Office of the NMPA on 25 April 2018 for public comments.
5 The Implementation Measures for Drug Trial Data Protection (Trial) (Draft for Comments) was issued by the General Office of the NMPA on 19 March 2025 for public comments.
6 Under China’s drug registration classification, the improved new drugs broadly cover:
- improvements to an existing active ingredient;
- new dosage forms, manufacturing processes or routes of administration;
- new fixed dose combinations of approved actives; and
- new indications for existing drugs.
In all cases, there is an expectation of clear clinical value or advantage.
