EMA consults on how to improve monitoring of clinical trials in third countries
This article was originally published in Scrip
The European Medicines Agency has issued for public consultation a reflection paper that considers how to better monitor clinical trials conducted in third countries (ie outside the European Economic Area (EEA)) and used to support marketing authorisation applications submitted to the agency.
You may also be interested in...
In the first of a two-part article on transparency provisions for the new EU clinical trial portal, the Pink Sheet reports on aspects that sponsors must consider to protect commercially confidential information in their clinical trial applications. The second article will look at the approach taken by Merck and discuss outstanding hot topics in relation to transparency and CTIS.
An independent audit of the new EU Clinical Trials Information System has finally commenced, indicating that plans are on track for the EU Clinical Trial Regulation to be implemented from December 2021.
EU regulators have agreed on supplementary pharmacovigilance requirements applicable to COVID-19 vaccines following approval.