6项国家药监局批准的高含金量突破性改革在北京有效落地

Core Viewpoint - Beijing has implemented six significant regulatory reforms approved by the National Medical Products Administration to promote high-quality development in the pharmaceutical industry, focusing on rare diseases and urgent clinical needs [1][2]. Group 1: Regulatory Reforms - The establishment of a green channel for the approval of urgently needed imported drugs and medical devices has led to the approval of 26 drug varieties, including 21 for rare diseases, benefiting over 4,900 patients [1]. - The clinical trial approval time for innovative drugs has been reduced from 60 working days to 30, with some projects approved in as little as 18 working days [1][2]. - The supplementary application review time has been cut from 200 working days to 60, with 33 pre-service applications received and the fastest approval in 19 working days [2]. Group 2: Import and Commercialization - Beijing has facilitated the import of 27 commercial-scale batches of previously listed overseas drugs, with a total customs value of 5.007 billion yuan [2]. - The number of pilot medical institutions for self-research and use of in vitro diagnostic reagents has increased from 6 to 15, completing the filing of 5 products [2]. Group 3: Innovation and Efficiency - The establishment of a national-level medical device innovation service station has served over 1,200 enterprises and resolved more than 3,000 consultation issues [3]. - The average review time for the first registration of Class II medical devices has been reduced to 45 working days, a 63% improvement over the legal limit of 120 working days [3]. - The Beijing Vaccine Inspection Center, the first of its kind in the country, is expected to be operational by the end of this year, capable of meeting the annual inspection demand for 4,000 vaccine batches [3].