China has revised regulations on drug administration to promote drug innovation, strengthen the management of online sales of medicines, and reinforce drug safety supervision.

The modified regulations for implementing the Drug Administration Law, which Chinese Premier Li Qiang signed a State Council decree to promulgate, comprise nine chapters and 89 articles and are set to take effect on May 15, an official statement said on Tuesday.

At the core of this revision effort is the drug research and registration system. The revised regulations emphasize a clinical value-oriented approach to drug development, encouraging innovation and supporting the clinical application and use of new medicines.

The document refines requirements for the management of clinical trials and introduces accelerated review pathways for drug marketing authorization. Clearer procedures are also provided for drug re-registration and for switching between prescription and over-the-counter medicines.

To incentivize innovation, the regulations grant market exclusivity to eligible pediatric medicines and drugs for rare diseases and provide data protection for drugs containing new chemical substances.

The modified rules also tighten the management of drug manufacturing. It also clarifies the management requirements for the production and sale of traditional Chinese medicine decoction pieces and granules.

In the area of distribution and use, the regulations improve the oversight of online drug sales and place greater responsibility on third-party e-commerce platform operators.

Support is also extended to medical institutions to boost the development of pediatric preparations that better meet the needs of pediatric patients.

The regulations further reinforce drug safety supervision by specifying inspection measures and detailing procedures for quality sampling and testing. They allow parties to request re-testing if they object to inspection results and impose stringent legal liabilities for violations.