创新药临床试验迎突破：将开启30日审评通道

Core Viewpoint - The National Medical Products Administration (NMPA) has proposed a draft to optimize the clinical trial review and approval process for innovative drugs, potentially reducing the approval timeline to 30 working days, which could significantly enhance the efficiency of drug development in China [1][2]. Group 1: Approval Process Changes - The new draft aims to compress the clinical trial review and approval period for key innovative drugs to 30 working days, with some regions like Beijing potentially reducing it to 18 days [2]. - The draft supports the development of drugs that are classified as traditional Chinese medicine, chemical drugs, and biological products, specifically focusing on three categories: nationally supported innovative drugs, drugs for children and rare diseases, and globally synchronized research products [1][4]. Group 2: Impact on Drug Development - The reduction in approval time is expected to significantly improve the efficiency of clinical trial initiation, allowing companies to accelerate their research and capture global market opportunities [2]. - The new policy is anticipated to lower research and development costs and risks, reduce waiting times for companies, and ultimately enhance the international competitiveness of China's pharmaceutical industry [2][3]. Group 3: Focus on Rare Diseases and Children's Drugs - The draft emphasizes the inclusion of drugs for rare diseases and children's medications, addressing unmet clinical needs in these areas [6]. - Currently, only about 10% of the over 800 rare disease drugs available globally have been approved in China, indicating a substantial market opportunity for new drug development in this sector [6]. Group 4: Responsibilities and Compliance - The draft introduces a requirement for applicants to demonstrate their capability in risk assessment and management, ensuring that clinical trials can commence within 12 weeks post-approval [3][4]. - Companies must establish robust drug safety monitoring and risk control systems to align with the expedited review process, ensuring quality and safety standards are maintained [7][8]. Group 5: Global Collaboration and Market Positioning - The inclusion of global synchronized research in the priority review channel is expected to enhance China's attractiveness as a key site for international multi-center clinical trials [2][5]. - Domestic innovative pharmaceutical companies, such as BeiGene and Innovent Biologics, are likely to benefit from this new policy, as it allows them to expedite the development of their first-class new drugs that align with national support directions [5].