Core Viewpoint - The Shandong provincial government has issued an implementation opinion aimed at deepening the reform of drug and medical device regulation, promoting high-quality development in the pharmaceutical industry through 29 specific measures across six key areas [2]. Group 1: Strengthening Innovation - The implementation opinion emphasizes the importance of medical innovation, focusing on cutting-edge areas such as gene therapy, cell therapy, synthetic biology, AI-assisted drug design, new vaccines, radioactive drugs, high-end medical devices, and modernization of traditional Chinese medicine [2]. - Shandong will support projects with significant original innovations and breakthroughs through provincial science and technology programs, enhancing the innovation platform system and encouraging enterprise-led innovation [2]. Group 2: Regulatory Efficiency - The reform aims to enhance efficiency by streamlining the review and approval process, integrating with the Beijing-Tianjin-Hebei review center to access more resources for drug and medical device evaluations [4]. - A scientific tiered review mechanism will be established, providing dedicated support for key innovative products while optimizing standardized review processes for routine projects to improve efficiency [4]. - The reform represents a systematic restructuring and digital transformation of the review and approval system, promoting full online processing of drug and medical device registrations and licenses, allowing for a more efficient workflow [4].