China deepens comprehensive reform to strengthen drug, medical device regulation

BEIJING -- China has issued a guideline on comprehensively deepening the reform of regulation of drugs and medical devices to promote the high-quality development of the pharmaceutical industry.

The document, issued by the General Office of the State Council, aims to accelerate the construction of a unified national market and foster a globally competitive innovation ecosystem to transform China from a major pharmaceutical manufacturer into a pharmaceutical powerhouse.

The guideline stipulates that by 2027, the legal and regulatory frameworks for drug and medical device supervision will be more enhanced, while the quality and efficiency of review and approval processes for innovative drugs and devices will be significantly improved.

By then, whole-lifecycle regulation in this field will be strengthened to ensure product safety and quality, as per the guideline.

It specifies that by 2035, China expects to fully ensure the safety, efficacy and accessibility of drugs and medical devices, and for its pharmaceutical industry to have stronger innovation, creativity and global competitiveness, with its regulatory system modernized.

The document outlines 24 reform measures across five key areas, which are — increasing support for innovation in R&D, improving review and approval efficiency, enhancing the compliance level of the pharmaceutical industry via efficient and strict supervision, expanding opening up and cooperation, and fostering a regulatory system that meets the needs of industrial development and safety.