China's Revised Drug Administration Regulations to Take Effect in May 2026

China's newly revised Implementation Regulations of the Drug Administration Law will take effect on May 15, 2026, marking the first comprehensive revision in over two decades with more than 90% of provisions amended. The New Regulations comprise nine chapters and 89 articles covering general principles, drug R&D and registration, marketing authorization holders, manufacturing, distribution, medical institution drug management, supervision, legal liability and supplementary provisions.

The regulations closely align with institutional reforms under the 2019 revised Drug Administration Law, further strengthening the marketing authorization holder system and the "lifecycle supervision" approach while incorporating mature regulatory reform experience. Key revisions include improvements to drug development and registration systems, with specific provisions for clinical trial sponsor changes, recognition of overseas research data, and accelerated approval pathways.

Article 9 establishes a formal mechanism for changing clinical trial sponsors, requiring applications to be filed with the national drug regulatory authority, which must review and decide within 20 working days from acceptance. Article 10 provides that overseas research data, if compliant with relevant requirements of the national drug regulatory authority, may be used for drug registration in China, which is particularly relevant for international multi-center clinical trials.

The New Regulations elevate key accelerated review and approval mechanisms into the administrative regulation tier, confirming that eligible applications may be subject to pathways such as breakthrough therapy, conditional approval, priority review and approval, and special approval to expedite market entry. Article 21 introduces a market exclusivity regime to incentivize R&D and supply for qualified pediatric and rare disease drugs, with strict constraints that exclusivity will terminate if marketing authorization holders fail to fulfill drug supply commitments.

Article 22 continues and improves the data protection framework, expanding the protected scope from drugs containing new chemical entities to such drugs and other qualified drugs. Chapter Three systematizes marketing authorization holder obligations, reflecting a regulatory shift from managing manufacturers and distributors to managing products and the full chain.

The regulations outline the qualification recognition process for institutions conducting non-clinical drug safety evaluation studies and refine requirements for the administration of clinical drug trials. Modified rules also strengthen the management of contract manufacturing, clarify the responsibilities of drug marketing authorization holders in contract manufacturing, and specify circumstances under which segmented pharmaceutical manufacturing can be commissioned.

Management requirements for the production and sale of traditional Chinese medicine decoction pieces and formula granules are specified. The revised regulations improve the management system for online drug sales and clarify the responsibilities of third-party online platform operators. Pharmaceutical administration in medical institutions will be enhanced to ensure drug quality at the usage stage.

Drug safety supervision and inspection measures are specified, while procedures for random quality inspections have been refined so that parties may apply for re-examination if they dispute inspection results. Stringent legal liabilities are imposed for any violation. Marketing authorization holders must establish and improve drug quality assurance systems and pharmacovigilance systems, assess the quality impact of manufacturing changes, and conduct post-marketing evaluations.

Article 28 links post-marketing evaluation to re-registration, stating that where a marketing authorization holder fails to continuously evaluate quality, efficacy and adverse reactions as required, or fails to conduct post-marketing evaluation as required, re-registration may be refused upon expiry of the registration certificate. Article 26 introduces accessibility requirements, mandating that marketing authorization holders provide drug labels and package inserts in accessible formats including audio, large-print, Braille, and electronic versions.