Implementation of ICH GCP 2022 by Usher DEU https://padlet.com/usherdeu/c2xtvvxq63camdc6 Use this map to pin the country you want to talk about. Click on the Add Post icon (pink circle top right) you can add text, links, media etc. en-us 2022-01-17 08:46:24 UTC 2023-02-06 13:23:17 UTC hello@padlet.com United Kingdom usherdeu https://padlet.com/usherdeu/c2xtvvxq63camdc6/wish/1995424978 The UK transposed EU Directives 2001/20/EC and 2005/28/EC into law by passing The Medicines for Human Use (Clinical Trials) Regulations (SI 2004/1031) in 2004, and then amending this (SI 2006/1928) in 2006. These Regulations contain 14 principles of GCP rather than the 13 principles of ICH GCP, although there is significant overlap.
ICH GCP is not explicitly mentioned in UK legislation, and so is not law per se. However, as part of European guidance within EudraLex Volume 10, it should be taken into consideration. And if ICH GCP compliance is claimed, then UK regulators expect that to be the case!
]]> 2022-01-17 08:47:54 UTC https://padlet.com/usherdeu/c2xtvvxq63camdc6/wish/1995424978 Australia https://padlet.com/usherdeu/c2xtvvxq63camdc6/wish/2452602513 ICH GCP guidelines are followed in Australia. Clinical trials in Australia are also subject to national law and regulations, principally the Therapeutic Goods Act of 1989 and Therapeutic Goods Regulations 1990. It is a requirement to follow the guidelines of the National Statement on Ethical Conduct in Human Research 2007.]]> 2023-01-22 22:19:51 UTC https://padlet.com/usherdeu/c2xtvvxq63camdc6/wish/2452602513 California, USA https://padlet.com/usherdeu/c2xtvvxq63camdc6/wish/2452976048 2023-01-23 09:47:40 UTC https://padlet.com/usherdeu/c2xtvvxq63camdc6/wish/2452976048 Germany https://padlet.com/usherdeu/c2xtvvxq63camdc6/wish/2452976357 2023-01-23 09:47:57 UTC https://padlet.com/usherdeu/c2xtvvxq63camdc6/wish/2452976357 Japan https://padlet.com/usherdeu/c2xtvvxq63camdc6/wish/2452976565 2023-01-23 09:48:09 UTC https://padlet.com/usherdeu/c2xtvvxq63camdc6/wish/2452976565