Revamped French agency to put the emphasis on post-authorisation monitoring
This article was originally published in SRA
Executive Summary
France's restructured healthcare products regulatory agency, which is expected to be fully operational in its new incarnation by next spring, will be putting the emphasis firmly on the post-authorisation monitoring of the safety and efficacy of medicines and medical devices1.
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.