AIPLA Comments on Draft NMPA Measures

Arlington, VA. May 17, 2025 –The American Intellectual Property Law Association (AIPLA) submitted comments in response to the National Medical Products Administration’s (NMPA) draft measures on the protection of drug trial data in China.

AIPLA emphasized the importance of strong regulatory data protection (RDP) to support pharmaceutical innovation and investment. The Association urged the NMPA to adopt longer, internationally-aligned RDP periods and opposed the proposed two-tier “window” system that would grant shorter protection to drugs first approved overseas. AIPLA also recommended allowing RDP for subsequent clinical trial data—such as bioavailability, bioequivalence, and immunogenicity—on a case-by-case basis. Concerns were raised regarding the use of the authorization date as the trigger for protection periods and the potential implications of granting a three-year exclusivity for the first generic.

AIPLA further recommended the inclusion of market exclusivity for orphan and pediatric drugs, noting that such provisions were referenced in previous draft guidelines but are currently absent.

The comments proposed clarifying key definitions, including expanding “chemical” to “active ingredient” under the term “Innovative Drug” and confirming that “undisclosed trial data in China” specifically refers to data not previously submitted to the NMPA. They also sought alignment with existing regulatory definitions for “Innovative Drug,” “Improved Drug,” and “Biosimilars.”

Lastly, AIPLA encouraged the NMPA to clarify how the draft measures align with existing regulations providing six years of exclusivity for new chemical entities and proposed administrative reforms to streamline application procedures, reduce burdens, and promote timely approvals.