China revises drug administration regulations to spur innovation, tighten oversight

BEIJING -- China has revised regulations concerning drug administration in a bid to promote drug innovation, strengthen 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 has 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. Management requirements for the production and sale of traditional Chinese medicine decoction pieces and granules are clarified.

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

Support is also extended to medical institutions for developing pediatric preparations to better meet the needs of child patients.

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