Review times for new drugs in Europe almost match those in the USA but many medicines are still getting to Americans quicker than they arrive in the Old Continent, according to a new report.
The Tufts Center for the Study of Drug Development says that approval times in the European Union have met “mandated performance goals,” and mean review times for new products approved in both the European Union and the USA during 2000-05 were nearly identical – 15.8 months for products approved by the European Medicines Agency and 15.7 months for those approved by the Food and Drug Administration.
The study states that recently-enacted EMEA regulations, such as conditional marketing authorisation and accelerated assessments, which parallel existing FDA initiatives, “enabled the agency to meet, or come close to meeting, its performance timeline goals for all product categories for each approval stage.”
Tufts CSDD director Kenneth Kaitin said that “while similar development times for new medicines on both continents is good news for patients, it's especially important for drug developers, because it enables them to pursue a coordinated global development programme and marketing strategy." Looking ahead, he added that “we expect that greater collaboration between the EMEA and FDA will further enhance product development in both regions. It will also help avoid duplicative testing and provide another way to hold down development costs."
The report also found that:
* For 71 products receiving both FDA and EMEA approval, the FDA acted faster than the EMEA in 47 of the cases.
* While the FDA approved a greater number of products faster than the EMEA during 2000-05, there was greater variability in FDA approval review times.
* Regulatory designation does not appear to have as much impact in the EMEA as in the USA, as exceptional circumstance approvals are, on average, only 1.5 months faster than non-exceptional approvals.
* Approval times for orphan products in the EU and the USA were nearly identical to those for non-orphan products in the same region.
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