毕井泉被查，他被认为是中国药审改革的关键人物

Core Viewpoint - Bi Jingquan is recognized as a key figure in China's drug review reform, significantly transforming the pharmaceutical industry and facilitating the integration of Chinese innovative drugs with global standards [1][2]. Summary by Sections Background and Career - Bi Jingquan was born in September 1955 and graduated from Peking University in 1978. He has held various positions in the National Development and Reform Commission and served as the Secretary-General of the State Council before leading the drug regulatory system [2]. - He became the head of the former State Food and Drug Administration (SFDA) in January 2015, where he initiated significant reforms in the pharmaceutical sector [2]. Key Reforms - Under Bi's leadership, several reforms were implemented, including speeding up drug review and approval processes, promoting the consistency evaluation of generic drugs, and piloting the Marketing Authorization Holder (MAH) system [2][3]. - In July 2015, the SFDA announced a self-inspection and verification initiative for clinical trial data, addressing long-standing issues of data fraud [2]. - In August 2015, the State Council released opinions on reforming drug and medical device review and approval systems, marking the official start of drug review reforms [2]. Accelerated Drug Approvals - In February 2016, the SFDA issued opinions to prioritize the review and approval of drug registration applications, leading to a significant acceleration in the market entry of innovative drugs [3]. - The same month, the State Council mandated that generic drugs must demonstrate quality and efficacy consistency with original drugs [3]. - The introduction of the MAH system in June 2016 aimed to stimulate innovation among pharmaceutical developers by aligning with international practices [3]. International Integration - In June 2017, China joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), integrating its drug regulatory system into internationally recognized frameworks [3]. Challenges and Resignation - The vaccine fraud incident involving Changchun Changsheng Biotechnology in July 2018 led to significant scrutiny and the resignation of Bi Jingquan from the SFDA [4]. - Following this, he was appointed as the first Secretary of the newly established State Administration for Market Regulation, where he was initially seen as a promising leader [4]. Recognition and Awards - In August 2020, Bi was appointed as a member of the 13th National Committee of the Chinese People's Political Consultative Conference and later became the Executive Vice Chairman of the China International Economic Exchange Center [4]. - In December 2024, he received a lifetime achievement award from the International Pharmaceutical Information Association, marking a historic recognition for a Chinese individual [4].