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Regulators Back More Reliance On GMP Inspection Results

 
• By Ian Schofield

As medicines agencies increasingly turn to worksharing and other mechanisms to reduce duplication of effort, the Access Consortium has thrown its weight behind the use of reliance processes for national good manufacturing practice inspection outcomes.

GMPBlocks
Regulatory reliance can reduce the GMP inspection workload • Source: Shutterstock

The five medicine regulators that form the international Access Consortium have come out strongly in favor of greater reliance on each other’s pharmaceutical good manufacturing practice (GMP) inspections as part of a drive to increase their collaboration throughout the product life cycle.

The heads of agencies from Australia, Canada, Singapore, Switzerland and the UK have issued a statement that they said would...

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

 
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Infographic: Leqembi – A Geographical Comparison

 
• By Anabel Costa-Ferreira

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

More from Geography

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.