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, a key figure in China's drug review reform, is under investigation for serious violations of discipline and law, which may impact the pharmaceutical industry and regulatory environment in China [2]. Group 1: Background and Career - Bi Jingquan was born in September 1955 and graduated from Peking University in 1978, starting his career at the National Price Bureau in 1982 [2]. - He worked in the National Development and Reform Commission (NDRC) from 1994 and served as the State Council's Deputy Secretary-General in 2008, later moving to the drug regulatory system [2]. - He is recognized for significant reforms in China's pharmaceutical industry, particularly during his tenure as the head of the former State Food and Drug Administration (SFDA) [2]. Group 2: Key Reforms and Initiatives - Under Bi's leadership, the SFDA implemented several reforms, including speeding up drug review and approval processes, promoting consistency evaluations for generic drugs, and piloting the Marketing Authorization Holder (MAH) system [2][3]. - In July 2015, the SFDA addressed long-standing issues of clinical trial data fraud, marking a significant step in drug approval reform [3]. - The introduction of the MAH system in June 2016 aimed to stimulate innovation in drug development by aligning with international practices [4]. Group 3: Impact on the Pharmaceutical Industry - Bi's reforms have been summarized as addressing key issues: approving generic drugs to ensure affordability, implementing consistency evaluations to guarantee efficacy, and accelerating the market entry of innovative drugs [5]. - In June 2017, China joined the International Council for Harmonisation (ICH), integrating its drug regulatory system into a globally recognized framework [5]. - The vaccine scandal in 2018 led to Bi's resignation, highlighting the challenges faced by regulatory authorities in maintaining oversight and public trust [5]. Group 4: Recognition and Awards - In December 2024, Bi Jingquan received a lifetime achievement award from the International Pharmaceutical Information Association, marking a significant recognition of his contributions to drug innovation and international collaboration [6].