Following the establishment of a patent linkage system for pharmaceuticals in 2021, China is now poised to implement another key pillar of its pharmaceutical intellectual property framework. In March 2025, China's National Medical Products Administration (NMPA) released the Draft Implementation Measures for the Protection of Pharmaceutical Trial Data ("Draft Measures"), along with accompanying Working Procedures. The final rules are expected to be issued in the course of 2026. Below is an overview of the key features introduced by the Draft Measures.

Scope and duration of protection

The Draft Measures provide protection for innovative drugs (six years), improved new drugs (three years), and the first generic or biosimilar approved in China for a drug already marketed overseas but not yet available domestically (three years). This last category is designed to incentivize efforts to bridge the foreign-domestic availability gap. Compared to the U.S. and EU regimes, which provide differentiated protection periods for specific categories such as orphan drugs, pediatric drugs, and qualified infectious disease products, the Draft Measures adopt a more streamlined classification approach.

Scope of protected data

The Draft Measures protect undisclosed trial data submitted by applicants to demonstrate a drug's safety, efficacy, and quality control. For improved new drugs and generics, protection is limited to clinical trial data, excluding bioavailability and bioequivalence data. Data protection applications must be submitted concurrently with marketing authorization applications.

The "countdown mechanism"

For drugs already approved overseas, the protection period is calculated as six years (or three years) minus the time elapsed between foreign first approval and China's acceptance of the filing. This mechanism is designed to encourage multinational companies to accelerate China market entry for their global products.

Protection for new indications

The Draft Measures allow each new indication approved under the same registration number to qualify for separate protection based on its registration category, recognizing the investment required to expand therapeutic uses of approved drugs.

The Draft Measures reflect China's effort to balance innovation incentives with generic drug accessibility – encouraging first-to-file generic development to improve drug availability while promoting simultaneous global-China product launches by originators. Pharmaceutical companies should monitor the legislative progress and evaluate how these rules may complement their patent protection strategies in China.