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thuytienlecao replied to the topic Discussion Topic: Easier regulatory in EU? in the forum EU Regulatory Basics 7 years, 2 months ago
My answer is maybe not. Other than the lecture video, I have limited area about this topic so I did a search on it and found some interesting information. From the lecture, various reasons you guys have mentioned and various articles you guys have pointed out I would say that it’s easier to get approval in EU than in the US. However I came across some articles that pointed out that despite the assumption that drugs/medical devices are approved more slowly in the United States, analysis showed that they actually reach the public faster in the United States than Europe (S.A. Roberts, “Despite critism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe”; S.Basu, “Patient access to medical devies-a comparion of US and European review processes”). Furthermore, ccording to Kramel et al., as of 2010 devices approved via the FDA 501(k) approval process only lagged behind EU approval by 18 days (D.B.Karmer, “How does medical device approval regulation perfom in the United States and the European Unnion? A systematic review”).
There is a good article from ScienceDirect with a comprehensive review about the European and US Approval Processes for Drugs and devices by Gail A. Van Normal in 2016 (somehow I can’t paste the link)