China introduces long-awaited pharmaceutical trial data protection legislation
On 19 March 2025, China’s National Medical Products Administration (NMPA) released a draft of the Implementing Measures for Pharmaceutical Trial Data Protection (for Trial Implementation), along with its accompanying implementation procedure, Working Procedures for Drug Trial Data Protection, for public comment. These long-awaited Draft Measures outline the specific periods and scope for pharmaceutical trial data. Specifically, data protection periods will apply to the following categories of drugs :
- Innovative drugs
- A six-year data protection period will be granted from the date of the first domestic marketing authorisation for the innovative drug.
- For original drugs already marketed overseas but not yet in China, the data protection period will be six years minus the time difference between the date the drug’s marketing application is accepted in China and the date it first obtained marketing authorisation overseas. In simple terms, the earlier an overseas innovative drug enters the Chinese market compared to its first overseas launch, the longer the trial data protection period it can enjoy.
- Improved new drugs
- A three-year data protection period will be granted from the date of the first domestic marketing authorisation for the improved new drug.
- For improved drugs already marketed overseas but not yet in China, the data protection period will be three years minus the time difference between the date the drug’s marketing application is accepted in China and the date it first obtained marketing authorisation overseas.
- Generic drugs
- A three-year data protection period will be granted to the first generic drug (including drugs produced overseas) and biologics that are approved for drugs already marketed overseas but not yet in China.
Although China’s Regulations for the Implementation of the Drug Administration Law first introduced provisions for pharmaceutical trial data protection as early as 2002, implementation of this system has faced significant controversy and resistance over the past two decades, and detailed rules have never been successfully issued.
Compared to the 2018 draft Implementing Measures for Pharmaceutical Trial Data Protection (Interim), released for public comment but ultimately shelved due to strong industry pushback, the new Draft Measures offer a relatively conservative protection period (i.e. 12 years maximum in the 2018 version versus six years in the current draft). In addition, by including generic drugs and biologics for products already marketed overseas but not yet in China within the scope of data protection, the draft seeks to strike a balance between encouraging innovation and supporting generic drug availability. This balanced approach helps reconcile the interests of various stakeholders, leading to a generally positive industry response, which may facilitate early adoption of the draft.
The draft, however, does not address certain highly anticipated issues, such as special data protection for rare disease drugs and paediatric drugs, which are likely to become points of contention during the public comment period.
CMS will be closely monitoring the progress of the public consultation. More details on the Working Procedures for Drug Trial Data Protection (Draft for Public Comment) will be covered in our next Law-Now update.
The original publication can be found here. (Chinese only).
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