山东药械监管改革三大突破，为产业创新加速护航

Core Viewpoint - The Shandong Provincial Government has introduced a new implementation plan aimed at enhancing the regulatory framework for pharmaceuticals and medical devices, focusing on innovation, efficiency, and collaborative support for the industry [1]. Group 1: Focus on Innovation and Support - The new implementation plan positions regulatory authorities as "innovation partners," providing proactive support during the early stages of product development for innovative drugs and devices. This includes assigning dedicated personnel for face-to-face guidance, aiming to reduce common issues and compliance risks in the R&D and registration processes [3]. - A notable example of this initiative is the expedited approval and production of Gan Li Pharmaceutical's insulin injection, which exceeded expectations [3]. Group 2: Focus on Review Efficiency and Process Optimization - The reform emphasizes a systematic restructuring of the review and approval processes, incorporating digital transformation. It aims to achieve full online processing for drug and medical device registrations, ensuring that all steps from application to certification are managed digitally, thereby minimizing the need for physical presence [4]. - The regulatory body will publicly commit to specific processing timelines for high-frequency matters, enhancing predictability for enterprises regarding the review process [4]. Group 3: Focus on Systematic Collaboration and Ecosystem Support - The plan aims to create a supportive ecosystem for the rapid development of innovative drugs and devices by ensuring smooth connections across various stages, including R&D, clinical trials, and market access. This includes optimizing the registration of clinical trial institutions and enhancing regulatory support for these entities [5]. - The regulatory authority will also strengthen collaboration with other departments, such as health and insurance, to address common challenges faced by innovative products in funding, clinical promotion, and insurance access [5].