20多年来最大规模的改革！欧盟医药领域或迎来变局｜全球监管动态

▎药明康德内容团队编辑

参考资料：

[1] EU releases draft legislation that will reshape pharma regulation. Retrieved April 28, 2023, from https://www.raps.org/news-and-articles/news-articles/2023/4/commission-releases-draft-legislation-that-will-re

[2] European Health Union: Commission proposes pharmaceuticals reform for more accessible, affordable and innovative medicines. Retrieved April 28, 2023, from https://ec.europa.eu/commission/presscorner/detail/en/ip_23_1843

[3] 国家药监局药审中心关于发布《慢性乙型肝炎病毒感染治疗药物临床试验技术指导原则》的通告（2023年第31号）. Retrieved April 28, 2023, from https://www.cde.org.cn/main/news/viewInfoCommon/5bebddb98aae85a980181683a910788e

[4] FDA officials offer CMC advice for gene therapies at OTP town hall. Retrieved April 28, 2023, from https://www.raps.org/news-and-articles/news-articles/2023/4/fda-officials-offer-cmc-advice-for-gene-therapies

[5] OTP Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls. Retrieved April 28, 2023, from https://web.cvent.com/event/153b9cc7-fe8c-4f4d-b394-09de87a80aee/summary