Agence Nationale de Sécurité du Médicament et des Produits de Santé, Boulevard Anatole France, 93200, Saint Denis, Grand Paris, France.
Rev Recent Clin Trials. 2023;18(3):167-171. doi: 10.2174/1574887118666230320124012.
The implementation of the new European Clinical Trial Regulation on 31 January 2022, is a major step to promote clinical research in Europe. The French National Agency for Medicines and Health Products Safety (ANSM) proposes to share some key aspects of the preparation for the application of the Regulation initiated in 2017 and to discuss shared indicators that should be considered to monitor clinical trials opportunities on a territory with regards to access to innovation for patients and attractiveness for sponsors. New criteria based on the time from the first request for authorisation to the first inclusion could be of particular interest to appraise the implementation of the European Clinical Trial Regulation.
2022 年 1 月 31 日，新的《欧洲临床试验法规》的实施是促进欧洲临床研究的重要一步。法国国家药品与健康产品安全局（ANSM）提出分享一些在 2017 年开始的法规应用准备方面的要点，并讨论应考虑的共同指标，以便根据患者获得创新的机会和对申办者的吸引力来监测某一地区的临床试验机会。新的标准可能基于从首次授权申请到首次纳入患者的时间，这对于评估《欧洲临床试验法规》的实施具有特别意义。
