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UK pharma groups planning M&A deals ‘must get their skates on’ and begin filing now if they want to benefit from the EU’s review process before the Brexit transition period ends on 31 December.
A free trade deal needs to be negotiated in record time and UK life sciences must face up to diverging from the EU.
Latest From Brexit
The UK regulator wants to be a “catalyst for change” in reducing regulatory burdens, saying that better regulation based on science is in everyone’s interest.
BVMed says the EU and the UK should set up a system of mutual recognition of medical device regulation to kick in when the UK’s EU exit transition period ends on 31 December.
The UK medicines regulator has a “unique opportunity” to evaluate the systems it operates and to “do things differently", according to its long-term interim head, June Raine.
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.
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.
Regulatory flexibilities combined with experience in cell and gene therapy and the wider use of technologies such as AI could help to keep the post-Brexit UK at the forefront of innovation in the life sciences. A UK regulatory conference will be discussing these and other key issues next week.
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.
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.
With time running out on the UK-EU trade deal negotiations, the UK life sciences industry looks at the fine print of the new guidance on medicines regulation and explains why a mutual recognition agreement is urgently needed.
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