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Set Alert for Brexit

‘Keep Planning For No-Deal Brexit,’ UK Govt Tells Pharma As Chaos Grows

Amid the growing mayhem in parliament over the Brexit process, life science companies have been advised to continue preparing for the possibility that the UK might leave the EU without a deal at the end of next week. 
United Kingdom Brexit Trade

UK Drug Pricing & IP Targeted As US Gears Up For Post-Brexit Trade Deal Talks

The US has published its final negotiating objectives for a post-Brexit trade deal with the UK, which include pushing for stronger IP protections and changes to UK processes for patient access to new drugs.

United Kingdom United States Brexit

Latest From Brexit

Latest Notified Body Approval Helps Brexit-Proof EU Medical Devices Regulation

As the implementation deadline for the EU Medical Devices Regulation looms, the seventh notified body to be designated – BSI Netherlands – may hold the key to Brexit-proofing the new system. 
Health OTC Drugs

EMA Gets Keys To New HQ And Restarts Some Stalled Activities

The European Medicines Agency has taken possession of its new HQ in Amsterdam and has hired 77 new staff members to make up for the severe staff losses it has witnessed on account of Brexit. 

Europe Brexit

Pharma Declares Wishlist As Brexit Heightens UK Election Stakes

The UK pharma industry association has underscored the sector’s importance while outlining its demands for the country’s policy around medicines and R&D.

United Kingdom Brexit

UK BIA Targets Next Government With ‘Biotech Manifesto’

The BioIndustry Association has laid out its wishlist for the next UK administration, including deep regulatory alignment with the EU after Brexit, a more “flexible” approach to health technology assessment appraisals of new drugs, and support for R&D.

United Kingdom Brexit

UK Industry Hit By Brexit Uncertainty, Spies Opportunity

While post-Brexit regulatory alignment remains a priority for the British self-care industry, the increased flexibility afforded by the MHRA becoming a sovereign regulator could allow the UK to become a beacon of innovation on the edge of a re-aligned Europe, says PAGB CEO John Smith.
Health OTC Drugs

BSI Netherlands Designated Against EU MDR In Vital Move That Should Brexit-Proof Clients

BSI Netherlands is the seventh notified body to be designated under the EU’s Medical Device Regulation. But this latest announcement is one of the most important yet.

Europe EU

US Pharma Firms Not In Post-Brexit Trade Talks

A UK TV program revealed secret meetings between drug makers and British civil servants but for its part, the American Pharmaceutical Group says it has had no discussions on any future US/UK trade deal.
United Kingdom Reimbursement

UK Gov't Disowns ‘Secret’ Meetings With US On Post-Brexit Drug Pricing

Brexit and the NHS are likely to be key issues as political parties in the UK prepare to campaign ahead of the general election in December. 

United Kingdom Pricing Debate

Record ABHI Reg Meeting Mulls EU MDR, The UK’s Options And The Business Of Risk Management

Risk management was the thread running through the ABHI’s annual regulatory conference. But the irrepressible theme of the MDR was the main draw for the 200 attendees, even though the MHRA and industry are still unaware of the shape of the UK’s future relationship with the EU.    

EU Regulation
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