NMPA to enhance drug regulation under revised rules — committed to a people-centered healthy policy and strengthen high-effect regulation

On Dec 31, 2025, the State Council executive meeting adopted a revision to the Regulation for the Implementation of the Drug Administration Law (hereinafter refers to "the Regulation").

The revised Regulation aims to further encourage drug research and innovation, strengthen the whole life-cycle control of drugs and provide a solid legal guarantee for high-level drug safety and the high-quality development of the pharmaceutical industry.

To ensure the effective implementation of the revised Regulation, the National Medical Products Administration (NMPA) will focus on a set of key tasks.

First, strengthening regulatory enforcement to ensure high-level drug safety. The NMPA will strictly implement responsibilities for drug safety, reinforce whole life-cycle quality control of drugs.

It will also enhance surveillance and inspection in key areas, intensify enforcement efforts and crack down on drug-related illegal activities to firmly prevent from crossing the redline of drug safety.

Second, it will continuously deepen reform on drug regulation to facilitate drug R&D and innovation.

The NMPA will increase support for drug research and innovation, continuously improve the quality and efficiency of drug reviews and approvals and accelerate the market entry of high-quality innovative drugs that meet public needs to consistently enhance the innovation vitality and market competitiveness of the pharmaceutical industry.

Third, efforts will be made to enhance regulatory capacity to continuously improve the efficiency of regulation.

The NMPA will develop a team of highly competent and professional personnel, innovate regulatory methods and optimize the regulatory system.

It will strengthen regulatory coordination across the whole life cycle of drugs, advance regulatory scientific research and continuously enhance regulatory capabilities to improve regulatory effectiveness and quality.

Fourth, the NMPA will give more policy publicity and interpretation, as well as training and instruction, to ensure effective implementation of laws and regulations.

Targeting regulatory authorities at different levels and different types of enterprises, the NMPA will conduct extensive and diverse policy promotions and trainings. These efforts will be centered on the revising background of the Regulation, reformed measures, regulatory requirements, and liabilities as outlined in the Regulation. These events aim to ensure a thorough understanding and accurate catch of the Regualtion's new stipulations and requirements, thereby creating a favorable environment for their implementation.

Fifth, accelerating the improvement of supporting systems and sound legal framework for drug regulation.

Based on the key systems defined in the Regulation, the NMPA will coordinate the formulation and revision of supporting regulatory documents and technical guidelines, refine specific management requirements and further implement the stipulations of the regulations to create a more integrated, optimal, scientific and holistic legal system for drug regulation.