Regulatory processes 'becoming more difficult for drugmakers'

Staff in regulatory affairs jobs at major pharmaceutical companies are finding it increasingly difficult to secure approval for new treatments.

This is according to Chris Stirling, head of pharmaceuticals at professional services provider KPMG, who has noted a sharp decline in the success rate for new treatments in the last decade.

He told the BBC Radio 5 Wake Up To Money podcast that this is due to the increasingly taxing regulatory environment, with many drugs that would have received clearance 15 years ago failing to gain approval today.

As such, pharmaceutical companies are seeing a growing number of drugs failing at the costly phase III clinical trials stage, with 55 products falling at this hurdle in 2010.

"This is really something that chief executives of all major pharmaceutical companies are worried about," Mr Stirling observed.

Earlier this month, a study from the Health Affairs Journal revealed that the European Medicines Agency is taking much longer to ratify new cancer drugs than the US Food and Drug Administration, due to the complexity of its approval process.

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