UK Explains Post-Brexit Pediatric Study Processes
MHRA Will Ask For UK-Relevant Info Such As Unmet Therapeutic Need
Executive Summary
The Medicines and Healthcare products Regulatory Agency has outlined the various common scenarios that may occur when companies submit a UK pediatric investigation plan after the Brexit transition period has expired.
You may also be interested in...
Brexit: UK To Change Drug Import And Export Rules From 2021
New guidance documents issued by the UK regarding medicines regulation after the end of the Brexit transition period cover the import of medicinal products from countries on an approved list, trade in APIs between the UK and third countries, and the acceptance of batch testing under existing mutual recognition agreements.
UK Regulator Explains Data Requirements For Converted EU Approvals
In another of the many guidances it has issued on medicines regulation in the post-Brexit UK, the MHRA explains the additional information it will need from companies whose EU marketing authorizations are converted into national MAs in January 2021, and the new labeling requirements for those products.
UK Offers Pragmatic Approach To Safety Reporting From Jan 2021
The UK’s approach to pharmacovigilance system requirements in the post-Brexit transition period will allow companies to leverage some of the existing structures put in place for EU systems.