Pharma: The Impact of Brexit on Pharma Drug Regulations

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

UK Explains Approach To Renewing Converted EU Drug Approvals in 2021

The Medicines and Healthcare products Regulatory Agency has put procedures in place to renew UK marketing authorizations that are grandfathered from the EU system after the Brexit transition period ends.

Topic EU Pharma-Brexit brexit

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Gloom Over Prospects For Brexit Trade Deal

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. 

Topic Pharma-Brexit Regulation Brexit

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

UK Offers Pragmatic Approach To Safety Reporting From Jan 2021

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.

Topic Pharma-Brexit brexit

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

The Brexit Timebomb: Expect Effects On Drug Regulation, IP, Research And Trade

June 24 was a seismic day, in more ways than one. The UK's decision to withdraw from the EU may have elated more than half of the voting public, but it has caused deep disappointment, anxiety and anger among many millions more in the UK, Europe and around the world.

Topic Pharma-Brexit brexit

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

UK Set For January Brexit After Conservatives Win Election

The Conservative Party's victory in the UK general election means the Brexit withdrawal deal will be able to pass. The UK will leave the EU by 31 January and enter a transition period during which medicines regulation will remain broadly unchanged.

Topic Regulation brexit Pharma-Brexit

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

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. 

Topic Pharma-Brexit Reimbursement

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

UK No-Deal Medicines Regulation Under Threat As Brexit Chaos Grows

Draft regulations on medicines and medical devices could get caught up in the chaos that seems about to engulf the UK parliament as opposition MPs attempt to avert a no-deal Brexit.

Topic Pharma-Brexit Regulation Brexit

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

How The UK Regulatory System Would Work In A No-Deal Brexit – Part 1

Regulations that would allow the UK MHRA to work as a standalone regulator in the event of a no-deal Brexit have been laid before parliament. They cover a host of areas including new drug approval procedures, conversion of existing EU marketing authorizations into UK ones, pediatric and orphan exclusivities, imported medicines, and regulatory fees.

Topic Pharma-Brexit brexit Regulation

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Desperate Measures: How To Soften The Impact Of No-Deal Brexit

Building more cold chain warehouses, finding alternative sources of medicine supplies, and halting parallel exports to mitigate product shortages. Just some of the ideas for tackling the consequences of a no-deal Brexit scenario put forward by industry representatives at a recent parliamentary committee hearing.

Topic Pharma-Brexit Brexit EU