我国医药产业进入高质量发展“快车道” 助力健康中国建设

Core Viewpoint - The Chinese pharmaceutical industry is entering a phase of high-quality development during the "14th Five-Year Plan" period, with significant reforms in drug research, approval, production, distribution, and usage being implemented by the National Medical Products Administration (NMPA) [1][3]. Group 1: Reform Measures - The NMPA is enhancing support for research and innovation by introducing ten specific measures to promote high-end medical device innovation and launching the "Spring Rain" initiative for the transformation of clinical research results [1]. - A new version of the "Chinese Pharmacopoeia" for 2025 has been published to guide industry standards effectively [1]. - The NMPA is developing implementation measures and procedures for drug trial data protection to strengthen intellectual property rights in pharmaceuticals [1]. Group 2: Approval Process Improvements - The NMPA aims to complete the review and approval of key innovative drug clinical trials within 30 working days [3]. - In 11 provinces and cities, a pilot reform for supplementary drug application approvals is being conducted, reducing the approval time from 200 working days to 60 working days [3]. Group 3: Regulatory Capacity and Global Cooperation - The NMPA is enhancing its regulatory capacity to support major national strategies and optimize the setup of regulatory technical support institutions [5]. - The NMPA is facilitating global cooperation by supporting enterprises to conduct drug clinical trials simultaneously worldwide and shortening the global market entry timeline for drugs [5]. - The NMPA is also expanding the scope of export sales certification for pharmaceuticals and medical devices to bolster the international presence of Chinese products [5]. Group 4: Scientific Action Plan - The NMPA is accelerating the establishment of three sub-centers in the Beijing-Tianjin-Hebei, Central China, and Southwest regions [7]. - A scientific action plan for drug regulation is being implemented to develop new regulatory tools, standards, and methods [7].