山西省推出医药产业高质量发展新政

Core Points - The article discusses the implementation of the "Several Measures for Deepening Drug and Medical Device Regulation Reform in Shanxi Province" aimed at promoting high-quality development in the pharmaceutical industry [1][2] Group 1: Support for R&D Innovation - The measures include six specific actions to support drug and medical device R&D innovation, such as strengthening core technology research, accelerating drug development to preclinical research, and encouraging the innovation and industrialization of drugs and devices [1] Group 2: Improvement of Review and Approval Efficiency - Seven specific actions are proposed to enhance the quality and efficiency of drug and medical device review and approval processes, including optimizing review mechanisms and expediting the approval of urgently needed drugs and devices [1][2] Group 3: Promotion of Innovative Product Application - Four specific actions are outlined to accelerate the application and promotion of innovative products, such as encouraging enterprises to increase the application of innovative results and optimizing support for imports and exports [1] Group 4: Regulatory Compliance Enhancement - The measures emphasize strict regulatory responsibilities and propose seven specific actions to improve compliance levels in the pharmaceutical industry, including promoting the quality enhancement of generic drugs and increasing the efficiency of supervision and inspection [2] Group 5: Development of a Regulatory System - Four specific actions are suggested to build a regulatory system that aligns with industry development and safety needs, such as strengthening regulatory capacity building and advancing regulatory information technology [2]