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US/EU Inspections MRA: Lessons Learned And Challenges Ahead for FDA

 
• By Neena Brizmohun

Regulators in the US are finding it easier to assess the capability of European inspectorates under the landmark mutual recognition agreement on inspections signed last year, but there are some important implementation challenges that still need to be addressed.  

US & EU flags
The FDA expects to meet its MRA deadline for assessing EU member states • Source: Shutterstock

The US Food and Drug Administration is finding it increasingly easy to assess the standards of the remaining European inspectorates that are to be included in the mutual recognition agreement (MRA) the US and EU signed last year on recognizing the findings of each other’s manufacturing site inspections. But figuring out how its staff will adapt to using the EU’s certification system for inspections will continue to evolve for the agency.

Since starting its audit of the EU’s supervisory system in 2014, the FDA has learnt “a lot” in terms of...

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

 
• By Neena Brizmohun

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

 
• By Eliza Slawther

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

 
• By Francesca Bruce

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

 
• By Eliza Slawther

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.

More from Geography

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

 
• By Neena Brizmohun

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.

Argentina Speeds Up Market Access Process

 
• By Francesca Bruce

Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.

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

 
• By Eliza Slawther

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.