BEIJING, Jan. 3 (Xinhua) -- 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.
In 2024, China approved the market entry of 48 innovative drugs and 65 innovative medical devices. Its number of drugs in development ranked second globally, and several domestically developed drugs gained approval for global markets.
To better support innovation in the sector, the guideline proposes the prioritization of resources for the evaluation and approval of innovative drugs and medical devices urgently needed for clinical use, which will help accelerate the market access process.
The document also includes provisions to reduce communication and consultation waiting times for clinical trials of innovative drugs that are needed urgently.
The clinical trial approval process will also be optimized, per the guideline, which proposes pilot programs to slash the approval timelines for clinical tests of drugs and medical devices from 60 to 30 working days.
The guideline highlights the importance of elevating the caliber of patents in the pharmaceutical sector while boosting their practical application and the efficiency of their conversion into marketable products.
Building on this, the guideline further proposes strengthening drug data protection.
Yang Ting, an official of the National Medical Products Administration, said that efforts are underway to define the scope, types and duration of data protection to ensure effective implementation.
The guideline also calls for improving the market exclusivity system by granting a defined market exclusivity period for eligible drugs, such as those used in the treatment of rare diseases and pediatric medicine, with the aim of effectively encouraging enterprises to increase investment in research and innovation. ■
