BEIJING -- The Premier of the State Council recently signed a State Council decree to release the revised Regulations for Implementing the Drug Administration Law of the People’s Republic of China (hereafter referred to as the Regulations), which are set to take effect on May 15, 2026. Comprising nine chapters and 89 articles, the revised Regulations mainly include the following key provisions.

Improvements have been made to the drug development and drug registration system. The Regulations support drug development and innovation that is clinical value-orientaled, encourage the research and development of new drugs, and support the clinical promotion and use of new drugs. The Regulations clarify the qualification recognition procedures for non-clinical safety evaluation research institutions and refine the management requirements for drug clinical trials. An accelerated drug market registration process has been established, along with clear procedures for drug re-registration and the switching mechanism between prescription and OTC drugs. Market exclusivity periods are granted for eligible pediatric and rare disease drugs, and data protection is provided for drugs containing new chemical components. The responsibilities of MAHs are also specified.

Drug production management has been strengthened. The Regulations impose stricter supervision over drug contract production, reinforcing the responsibilities of MAHs and clarifying the circumstances under which segmented drug production may be contracted. The Regulations also specify the management requirements for the production and distribution of TCM decoction pieces and TCM formula granules.

The Regulations normalize drug distribution and use. They improve the management system for online drug sales, reinforcing the responsibilities of third-party online drug trading platforms. Additionally, they strengthen pharmaceutical management in medical institutions to ensure drug quality in use. The Regulations outline the approval process for preparations formulated by medical institutions, define the conditions and procedures for the transfer and use of such preparations, and support the formulation of pediatric medical institution preparations to meet the medication needs of child patients.

Drug safety supervision has been intensified. The Regulations specify measures for drug safety inspections and refine the procedures for drug sampling and testing. They also stipulate that relevant entities may apply for re-inspection if they dispute the test results. Strict legal liabilities have been established for violations of the Regulations.

(NMPA website: 2026-01-27)