UK Helps Sponsors Check Suitability Of Submissions Via International Recognition Procedure
Executive Summary
Six weeks before the UK is set to roll out its new International Recognition Procedure, it has developed an online tool to help facilitate a smooth and efficient process for companies wanting to use the new medicines assessment pathway.
You may also be interested in...
How To Use The UK’s New International Recognition Pathway For Drug Approvals
Eligibility criteria, how to apply, 60-day and 110-day timetables, major objections and clock stops. These are among the topics that the Medicines and Healthcare products Regulatory Agency covers in newly published guidance for drug companies planning to use the soon to be launched IRP.
UK Reveals Seven Partners Whose New Drug Approvals It Will Recognize
The UK regulator, the MHRA, says that while it will recognize drug approvals granted in the EU and a selection of other countries, it will remain a “sovereign regulator” with the ability to reject applications if they don’t meet its standards.
Global Medtech Guidance Tracker: November 2023
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.