On 31 December 2025, China’s State Council announced a revision of Regulation for the Implementation of the Drug Administration Law, which is expected to encourage research and innovation in the country. This revision aims to strengthen the legal foundation for ensuring high-level drug safety and supporting the high-quality development of the nation’s pharmaceutical industry.
To enact the changes, China’s National Medical Products Administration (NMPA) will focus on a set of key tasks.
The NMPA will strengthen regulatory enforcement to ensure high-level drug safety through strict implementation of responsibilities and the reinforcing of whole life-cycle quality control of drugs. In this regard, it will also enhance surveillance and inspection at all stages of the drug life cycle and crack down on drug-related illegal activities.
Additionally, the NMPA will further develop reforms in drug regulation to facilitate drug R & D and innovation. Alongside this, it will continue working to improve the quality and efficiency of drug reviews and approvals, thereby accelerating the market entry of high-quality innovative drugs that meet public needs and are globally competitive.
The NMPA will also work to enhance regulatory capacity in order to continuously improve the efficiency of regulation. This includes developing a highly competent and professional workforce, innovate regulatory methods, and optimizing the regulatory system.
Its objectives are to strengthen o strengthen regulatory coordination across the drug life cycle, advance regulatory science research, and continuously enhance regulatory capacity to improve effectiveness and quality.
The NMPA will increase the visibility of its policies by providing interpretation and guidance to ensure effective implementation of laws and regulations by all stakeholders, particularly manufacturers and developers.
Targeting regulatory authorities at different levels and various types of enterprises, the NMPA will conduct extensive and diverse policy promotions and training sessions. The NMPA aims to revise the Regulation from the ground up, reforming measures, regulatory requirements, and liabilities. Alongside these reforms will come broad and varied policy promotions and training at all levels and types of enterprises involved in the product life cycle. This will help all stakeholders better understand updates to regulatory requirements.
Finally, the NMPA will coordinate the improvement of supporting systems and the development of a sound legal framework for drug regulation. In this regard, the NMPA noted, ‘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’.
China-based companies are now responsible for 20% of drugs in development globally [1], and US pharmaceutical companies are increasingly licensing high-quality drug assets from China to replenish their pipelines amid a looming patent cliff. This strategic shift, involving billions in deal value, highlights China's growing role as a global innovation hub in biopharma [2]. The updates to China's drug administration regulations are therefore a timely and critical step to support this momentum.
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References
1. GaBI Online - Generics and Biosimilars Initiative. China now accounts for 20% of global drug development [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Mar 4]. Available from: www.gabionline.net/reports/china-now-accounts-for-20-of-global-drug-development
2. GaBI Online - Generics and Biosimilars Initiative. More China licence deals for US drug companies [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Mar 4]. Available from: www.gabionline.net/reports/more-china-licence-deals-for-us-drug-companies
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