Published: 20:07, January 3, 2025
China to better regulate administrative inspections on firms
By Xinhua
Staff members pack medicines at a pharmaceutical company in Central China's Hunan province, Dec 19, 2022. (PHOTO / XINHUA)

BEIJING - The General Office of the State Council has issued a document on strictly regulating administrative inspections on companies, aiming to curb arbitrary inspections and effectively ease the burdens on companies.

Profit-driven and indiscriminate administrative inspections should be prevented to better regulate the manner in which inspections are carried out, the document said.

By the end of June this year, relevant State Council departments shall have established an inspection system that covers different levels and categories, and the existing standards for administrative inspections shall be made public.

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By the end of this year, a mechanism for assisting administrative inspections in other locations should be well established, and relevant rules need to be made clear, the document added.

Drug, medical device regulation

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.

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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.