The Evolution Of Drug Regulation In Post-Brexit Britain

Regulatory reliance is playing an increasingly important role in gaining marketing authorization in the UK following Brexit. Meanwhile, the country’s unique Innovative Licensing and Access Pathway is attracting growing levels of interest, not just from companies but from regulators and health technology appraisal bodies across the world.

UK Drugs
The UK's ILAP aims to marry regulatory and HTA processes to deliver quicker market access for drugs • Source: Shutterstock

The post-Brexit UK is continuing to make its way outside the EU with a view to ensuring it is an important market for attracting investment, launching innovative new medicines and conducting clinical research. The Pink Sheet takes a look at how the country is managing to develop its regulatory and market access environment in an effort to achieve those aims.

In 2022, the importance of international collaborations and regulatory reliance was cemented as a way of securing quicker marketing authorizations....

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 United Kingdom

Pharma’s Protests Fall Flat As UK Locks In High Rebate Rates

 

Despite pushback by industry, the government is standing by its new statutory scheme rebate rates for branded medicines, including one that doubles the rate that companies must repay on the sales of newer products to the National Health Service to 31.3%.

Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
• By 

The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.

UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 

The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.

What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 

The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.

More from Europe

What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 

The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.

‘Brainless’ US MFN Policy Could Drive Pharma Investment To Europe

 

European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.

Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.