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FDA and EMEA keen to expand cooperation arrangement
 
 
  19/06/2007
www.pharmatimes.com
 
European and US health regulators have agreed to expand their present cooperation plans to cover areas such as paediatric treatments and orphan drugs.
 
After a two-day meeting, the US Food and Drug Administration, the European Commission and the European Medicines Agency have decided to broaden a previous arrangement which saw the regulators sharing information on vaccines, oncology drugs and pharmacogenomics. They will now "further the interactions" in the areas of paediatrics and orphan drugs and "furthermore, scientific dialogue has been widened to include extensions of therapeutic indications and risk management plans".
 
The expansion of this cooperation has been prompted in part by newly-adopted paediatric legislation in Europe, which came into force this year, some nine years after the USA adopted such laws, and following the establishment of the 'Framework for Advancing Transatlantic Economic Integration' between the EU and the FDA, new areas of regulatory cooperation were also discussed, notably concerning medical devices and cosmetics.
 
The agencies also noted that "in an effort to avoid future disharmony, upstream regulatory cooperation on new medicines legislation was discussed and a new initiative, the 'Transatlantic Workshop on Administrative Simplification in Medicines Regulation' will be held in November in Brussels, Belgium. The bodies concluded by saying that "the ultimate goal of the initiative is to promote and protect public health, reducing regulatory burden and costs, and bringing innovative products to patients in a timely manner''.
 
The disparities between the different systems of approval for pharmaceuticals are still considerable, a fact that was recently highlighted when an FDA expert panel voted against recommending Sanofi-Aventis 's obesity drug Acomplia (rimonabant) for approval in the USA because of suicide risks, although the EMEA gave the drug the green light last June.
 
 
 
 
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