Reflection and recommendation as EU and US scrutinise foreign trial data
This article was originally published in SRA
Executive Summary
The integrity of clinical trial data is never far from the spotlight these days, with companies and regulators coming under increasing pressure to be more transparent in how they report and publish trial results.
You may also be interested in...
Changes To EU Pharma Reform: More Questions Than Answers?
In the first of a series of articles on the future direction of the EU pharmaceutical reform proposals, the Pink Sheet looks at the new uncertainties created for the drug industry after the European Parliament voted through a series of amendments in the area of regulatory data protection.
Post-Brexit UK Risks Being ‘Left Out In The Cold’ As EU Coordinates Action On Shortages
The UK is not alone in experiencing drug shortages, as data from across Europe show, but its departure from the EU makes it more difficult to respond to supply chain pressures, according to new research.
EU Countries Offered Funding To Contribute to African Regulatory Strengthening
Training projects are intended to strengthen the African regulatory environment, boost the capacity of the African Medicines Agency, facilitate regulatory reliance, and increase joint new drug assessments.