EU-UK Trade Deal Allows For Mutual Recognition Of GMP Inspections

But No MRA For Batch Testing And Release

The trade deal agreed by the EU and the UK may have brought some relief to the life sciences sector in that it averts the chaos that would have followed failure to reach a deal, but it contains little that will have a direct impact on the regulation of medicines.

Brexit
The post-Brexit EU-UK trade deal will take effect on 1 January 2021 • Source: Shutterstock

Following almost of year of highly charged negotiations, the UK-EU trade and cooperation agreement will come into force on 1 January 2021, after it was signed by the presidents of the European Council and the European Commission on 30 December, one day before the expiry of the Brexit transition period.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

Leqembi Launch Set For Germany & Austria, EU-Wide Staggered Release Planned

 

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.

EMA Initiative To Address Information Overload In CTIS Training Materials

 
• By 

The European Medicines Agency has launched a phased initiative to consolidate the wide array of training materials for the Clinical Trials Information System, aiming to eliminate duplication, ensure consistency, improve accessibility and enhance user-friendliness.

HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By 

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.

French Bill Could Improve Clinical Research, But Further Action Is Required

 

France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.

More from Geography

US FDA’s Advanced Manufacturing Designation Lifts Off With Cellares Cell Shuttle

 

Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA

HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By 

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.

African Medicines Agency Set To Launch With New Leader In April

 

The African Medicines Agency is to appoint a director general and become operational at the end of this month.