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EMEA chief: We must improve

The European Medicines Agency has called for slower release times for new medicines and improved independent monitoring of products.

The European Medicines Agency (EMEA) has entered the global debate on drug safety by calling for slower release times for new medicines and improved independent monitoring of pharmaceutical products.

Speaking to the Financial Times, EMEA executive director Dr Thomas Lˆnngren argued that the top European drug regulator had to improve its drug monitoring network. He also said EMEA had to do more to detect possible side effects both before and after drugs reach the market in a bid to lessen the risks to patients.

ìWe have to find alternative methods to detect the safety of medicines,î he said. ìThere is an urgent need to build up independent networks of intensive drug monitoring. If we had better follow-up already in place, we might have discovered problems earlier.î

Although, since last year, companies have had to submit their own risk management plans on new products as a condition of their approval, Dr Lˆnngren said the current system, which focuses mainly on the industry and medical professionals to identify safety risks, was still inadequate.

ìDepending on the financial capacity, we have to set up independent studies, probably selecting a number of products that reach a great part of the population with chronic, well-known diseases,î he added.

Dr Lˆnngren's words will do little to calm industry fears that further regulatory reform could hamper drug development and in some cases render it unsustainable. Many pharma executives fear that recent high profile cases involving the COX-2 and SSRI classes of drugs have unnecessarily dragged the wider issue of overall drug safety into greater prominence.

Last week, speaking at his company's Q4 results presentation, AstraZeneca CEO Sir Tom McKillop called for public calm over drug safety. He warned that regulators could come under increased political pressure to monitor drug safety, adding that this might discourage innovative R&D in the future.

The EMEA, which celebrates its tenth birthday this week, has often been overshadowed by the US Food and Drug Administration but is slowly raising its profile. From November this year, it will be able to ìfast-trackî life-saving new drugs, by granting conditional approvals in much the same way as the FDA can currently.

30th September 2008

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