China Introduces Drug Trial Data Protection with Up to 6-Year Exclusivity

Release Time：2026-06-26 10:04Author：Views：0

China's National Medical Products Administration (NMPA) has issued the Implementation Measures for Drug Trial Data Protection, effective from 15 May 2026. The new regime grants regulatory data exclusivity for clinical trial data submitted in marketing authorisation applications, creating a second layer of IP protection alongside the patent system.

Protection periods vary by drug category:

Innovative drugs and originator drugs not yet marketed in China – 6 years from domestic approval.

Improved new drugs – 4 years.

First generics of originator drugs – 3 years.

Ordinary generics and biosimilars – not eligible.

During the protection period, the NMPA will neither accept nor approve any application filed by other applicants that relies on the protected data without the holder's consent. Applicants may, however, file independent applications based on their own data – such applications will be approved if they meet standards, but will not themselves receive data protection.

The protected data covers undisclosed, complete trial data first submitted in China to demonstrate safety, efficacy and quality control. For improved new drugs, protection is limited to new clinical data showing obvious advantages, excluding bioavailability, bioequivalence and vaccine immunogenicity data.

Application procedure: Applicants may request data protection concurrently with their marketing application. For applications already accepted but not yet finalised as of 15 May, a 15‑day window (until 30 May) is given to submit a protection request; otherwise the right is forfeited.

The NMPA states that this system, working in tandem with patent protection, provides “dual protection” for R&D investment, rewards genuine innovation, and prevents “free‑riding” on costly trial data – ultimately fostering a sustainable innovation ecosystem in China's pharmaceutical sector.

Source: IPR in China and NMPA

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