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New Safety Regulations Drive Greater Need for Resources and Expertise at Every Stage of Clinical Development
Date:6/18/2009

DUBLIN, June 18 /PRNewswire-FirstCall/ -- According to a report issued today, drug safety leaders in pharmaceutical and biotechnology companies recognise the need to increase resources, either internally or through partnerships, to comply with the safety regulations recently issued by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA). The report - Safety First: The Impact of New Regulations on Clinical Development - is based on a survey of 140 industry safety specialists, including heads of medical, drug safety, pharmacovigilance, and regulatory departments within large and mid-sized pharmaceutical companies and biotech firms. The survey found that more than three-quarters (77%) of respondents believe that new safety regulations have had a considerable impact on the industry as companies implement drug safety regulations throughout the clinical development process.

The FDA and EMEA have recently introduced more rigorous safety regulations, with a particular emphasis on post-marketing surveillance, to ensure that medications are monitored for their safety and effectiveness over the long term, across wide populations, and in real-life settings. The survey findings also highlighted regulatory departments in particular as having a pressing need for greater resources, with more than half of those surveyed (53%) requiring resources within the next six months.

"The transition from performing passive post-marketing surveillance to active safety monitoring using Phase IV studies, safety registries and comparative effectiveness programmes, is to ensure that benefit/risk re-assessment continues as safety information on the real-world use of products is revealed. Although initially resource intensive, this more rigorous approach to obtaining and analysing post-approval safety data will better ensure the public's confidence in a product's true safety profile. The real challenge will be
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SOURCE ICON plc
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