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Brexit

Set Alert for Brexit

CEO of New UK Cell And Gene Therapy Hub Says 'All Systems Are Go'

CEO of the Stevenage-based center hopes the new cell and gene manufacturing hub will see a growing life sciences ecosystem coalesce around it.

Regenerative Medicine United Kingdom Manufacturing

Sanofi Top UK Exec Plans For Hard Brexit, Blasts 'Poor Access' To New Drugs

The managing director for Sanofi in the UK says clinical trials there will become less likely in future if access to innovative drugs doesn't improve, causing comparative standards of care to deteriorate.

Brexit Business Strategies Clinical Trials

Latest From Brexit

Unease Mounts Over Brexit Drug Shortage Risk

Not enough is known about how industry is preparing for Brexit when it comes to drugs approved via Europe’s mutual recognition and decentralized procedures. National regulators are urging companies to get their house in order.

Brexit Market Access

EMA To Discuss Reactivating Landmark Clinical Trials Transparency Policy

The European Medicines Agency will be looking at reviving its policy on proactive publishing of clinical study reports, which is currently suspended as the agency copes with huge staff losses on account of Brexit.
 
Europe Brexit

No-Deal Brexit Means ‘Re-Planning A Whole Industry,’ Says ABPI Chief

Mike Thompson, head of the Association of the British Pharmaceutical Industry, outlined his industry’s concerns over medicines stockpiling, batch testing, tariffs, regulatory collaboration and other issues at a parliamentary committee hearing on the implications of a no-deal Brexit.

Brexit Europe

QUOTED. Oct. 11, 2018. Jonathan Mogford.

Negotations over the UK's impending exit from the EU are heating up, but there is not enough focus on what needs to happen to get to a mutually beneficial agreement between the two parties, says a top official at the UK agency that regulates devices and. See part of what Jonathan Mogford had to say here.

Brexit Quoted

Brexit: We Really Are Worth Keeping, Says Senior UK Regulator

Not enough is being said about how to get a positive outcome from Brexit and those interested in seeing a continued close regulatory partnership between the UK and the EU should make their voice heard, says Jonathan Mogford, policy director at the Medicines and Healthcare products Regulatory Agency.

Brexit Policy & Regulation

Brexit: We Really Are Worth Keeping, Says Senior UK Regulator

Not enough is being said about how to get a positive outcome from Brexit and those interested in seeing a continued close regulatory partnership between the UK and the EU should make their voice heard, says Jonathan Mogford, policy director at the Medicines and Healthcare products Regulatory Agency.

Brexit Regulation

UK MHRA No-Deal Proposal Must Be Carefully Managed, UK Medtech Industry Leader Warns

Questions still remain related to the recent technical notices and consultations from UK MHRA on the effects of a no-deal Brexit. Association of British Healthtech Industries' Phil Brown offers pointers as interested parties prepare to respond the consultations, which have a November 1 deadline.

Medical Device Europe

Helping Hand: A Guide To The New UK Consultations On No-Deal Brexit Regs

With just over three weeks to provide input on the UK's proposed regulatory response to the prospect of a no-deal Brexit, Medtech Insight unravels key messages from the four documents issued by the Medicines and Healthcare products Regulatory Agency (MHRA), condensing 127 pages into the main points to aid industry in providing feedback. There's no time to waste for those wishing to influence the outcome.

Europe United Kingdom

MHRA Admits UK Medtechs Exposed To Risks As It Consults On Brexit No-Deal Impact

The UK Medicines and Healthcare products Regulatory Agency is now consulting, in detail, on what a no-deal Brexit could look like and how it would impact manufacturers and the MHRA itself. Companies have less than four weeks to respond.

Brexit Regulation
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