Some 1,300 trials in the UK may have to stop their work if the UK leaves the EU without some kind of new regulatory regime in place, officials at Germany’s Federal Institute for Drugs and Medical Devices say in a new advisory published last week.
German regulators are warning trial sponsors that changing a representative requires “substantial amendments” to a trial’s regulatory regime. Sponsors should file a single amendment focused on their post-Brexit move to the continent and let any other regulatory questions lie for now. It will probably take 20-35 days, on average, to process the new filings, the institute says.
If sponsors are only changing their legal representative, “it is possible to submit this amendment for several clinical trials of one single sponsor by way of a collective amendment,” the advisory says.
Read the regulatory update here: https://bit.ly/2txx3Ri.
I coսld not refrain from commenting. Weⅼl written!