ISSUING AUTHORITY:

National Health Commission

DATE OF ISSUANCE:

April 28, 2026

EFFECTIVE DATE:

May 1, 2026

Jointly formulated with National Medical Products Administration (NMPA), the Interim Guiding Principles for Defining Biomedical Technologies Versus Pharmaceuticals and Medical Devices (the “Guiding Principles”) clarify the classification boundary between innovative biomedical technologies such as cell therapy and gene therapy, pharmaceuticals, and medical devices, underpinning State Council Order No. 818 (promulgated in 2025, effective May 1, 2026). The National Health Commission (NHC) issued these Guiding Principles on April 28, 2026, which then took effect on  May 1, 2026.

The Guiding Principles introduce a staged approach: early-stage technologies follow a guided self-identification filing list, while highly personalized therapies for unmet medical needs or rare diseases undergo evaluation by designated expert bodies. The rules align safety oversight with industry innovation, reducing regulatory ambiguity for foreign-invested R&D and clinical translation in advanced biotech.

Reference:

国家卫生健康委关于印发生物医学新技术与药品、医疗器械界定指导原则（暂行）的通知