China’s State Council has released the “Opinions on Fully Deepening the Reform of Drug and Medical Device Supervision to Promote the High Quality Development of the Pharmaceutical Industry.” The goal is to significantly improve the legal and regulatory system for drug and medical device supervision by 2027. This includes enhancing the regulatory system, mechanisms, and methods to better align with the needs of pharmaceutical innovation and high-quality industrial development.
Enhancing Evaluation and Approval Processes
By 2027, the State Council aims to significantly improve the quality and efficiency of the evaluation and approval of innovative drugs and medical devices. The supervision of the entire lifecycle will be strengthened, and the quality and safety levels will be comprehensively improved, establishing a regulatory system compatible with pharmaceutical innovation and industrial development. By 2035, the quality, safety, effectiveness, and accessibility of drugs and medical devices will be fully guaranteed, enhancing the pharmaceutical industry’s innovation and global competitiveness.
Support for Key Innovative Drugs and Medical Devices
More resources will be directed towards the review and approval of key innovative drugs and medical devices that are urgently needed in clinical practice. An action plan will be implemented to improve national standards for drugs and medical devices, actively promoting the research and transformation of standards for new technologies, methods, and tools.
Data Protection and Market Exclusivity
When certain drugs are approved for market, a data protection period will be granted for the self-obtained and undisclosed trial data and other data submitted by the registration applicant. Market exclusivity periods will be provided for rare disease drugs, pediatric drugs, the first approved chemical generic drugs, and exclusive traditional Chinese medicine varieties that meet the conditions.
Accelerating Innovation and Market Access
The government will accelerate the layout of original patents for drugs and medical devices, improving patent quality and conversion efficiency. It will also intensify the comprehensive clinical evaluation of innovative drugs and strengthen the analysis and application of evaluation results. Additionally, the government will shorten the waiting time for communication and exchange in clinical trials of urgently needed innovative drugs and prioritize the review and approval of key varieties.
Exemptions and Expanded Export Opportunities
Innovative drugs and medical devices that meet the criteria for rare diseases will be exempt from clinical trials. The accession to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) will be accelerated, and the scope of issuing export sales certificates will be expanded to include all qualified enterprises producing drugs and medical devices in accordance with production quality management standards.-Fineline Info & Tech
