Core Viewpoint - The implementation plan for the reform of drug, medical device, and cosmetic regulation in Hainan aims to enhance the competitiveness of the biopharmaceutical industry by introducing 20 reform measures across five key areas [1][2] Group 1: Regulatory Reforms - The plan emphasizes improving the efficiency of review and approval processes, focusing on the actual needs of enterprises during product development and registration [1] - It aims to facilitate the market entry of innovative products, targeting the launch of at least one innovative product annually and the introduction of over 60 licensed medical devices each year [1] Group 2: Innovation in Biopharmaceuticals - The initiative seeks to address bottlenecks in innovation by enhancing clinical research levels and increasing support for traditional Chinese medicine research and development [2] - By the end of 2027, the goal is to promote the registration or filing of over 15 hospital preparations [2] Group 3: International Competitiveness - The plan includes regulatory innovations to enhance product participation in international markets, aiming to create a high ground for real-world research applications [2] - It promotes the "Research and Use + Haikou/Qionghai Production" model to facilitate local production of more innovative drugs and medical devices [2] Group 4: Industry Development - The implementation of the plan is expected to significantly promote structural adjustments, efficiency transformations, and quality improvements in Hainan's biopharmaceutical industry [2] - It aims to create a unique competitive advantage for Hainan's biopharmaceutical sector, contributing to the establishment of a modern industrial system with Hainan characteristics [2]