China has revised regulations concerning drug administratio 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 issued on Tuesday said.

At the core of this revision effort was the drug research and registration system.

The revised regulations emphasised a clinical value-oriented approach to drug development, encouraging innovation and supporting the clinical application and use of new medicines.

The document refined requirements for the management of clinical trials and introduced accelerated review pathways for drug marketing authorisation.

Clearer procedures were also provided for drug re-registration and for switching between prescription and over-the-counter medicines.

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

The modified rules also tightened the management of drug manufacturing.

Management requirements for the production and sale of traditional Chinese medicine decoction pieces and granules were clarified.

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

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

The regulations further reinforced drug safety supervision by specifying inspection measures and detailing procedures for quality sampling and testing.

They allowed parties to apply for retesting if they objected to inspection results and established stringent legal liabilities for violations. 
(Xinhua/NAN)