State Council Publishes Revised Regulations on the Implementation of the Drug Administration Law

The State Council promulgated the Regulations on the Implementation of the Drug Administration Law of the People’s Republic of China (the “Regulations”).

The Regulations were revised and adopted on December 31, 2025, and will take effect on May 15, 2026. In terms of development and registration: non-clinical safety evaluation institutions must obtain qualification certification (valid for five years); clinical trial sponsors are required to bear liability and are prohibited from charging trial subjects; overseas data meeting requirements may be used for registration; rules are established for the selection of comparator drugs/reference preparations; pediatric drugs are granted up to 2 years, and rare disease drugs up to 7 years of market exclusivity and supply commitment; the protection period for undisclosed trial data shall not exceed six years.

For marketing authorization holders: establishing a pharmacovigilance system; ensuring labeling and instructions are accessible, with electronic instructions having equal validity; implementing categorized management of production changes and regulatory corrective actions; linking post-marketing evaluation with re-registration.

For production and operation: restrictions on entrusted production (prohibited in principle for special categories of drugs) and conditions for segmented production; obligations regarding drug traceability identifiers and information provision; reviewing and management requirements for online drug trading platforms and prohibition of online sales for specially controlled drugs; for traditional Chinese medicine decoction pieces and formula granules, manufacturers must engage in self-production and processing, comply with filing requirements for cross-provincial sales, and formula granules are prohibited from being distributed by drug distributors; additionally, specifing details on supervision and inspection, sampling and re-testing, as well as legal liabilities.