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.
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£10m Cash Boost For UK Regulator To Speed Up New Drug Approvals
An injection of new money should provide something of a shot in the arm for the UK’s drugs regulator as it deals with post-Brexit realities.
UK Prepares For New International Regulatory Reliance Framework
From next year, more agencies will be involved in the UK’s regulatory reliance procedure for new drug approvals, which was first introduced in 2021 to allay fears of post-Brexit delays to UK applications. The pharmaceutical industry said it looked forward to working with the regulator on the new framework.
What Would An EU ‘Regulatory Sandbox’ Bring To New Drug Development?
Digital health, AI, real-world evidence and “proactive learning” are key components of the EU’s proposals for new ways of regulating novel medicines, but only time will tell which products might benefit from the flexibilities offered by the “regulatory sandbox.”