01.16.07
Despite successful performance goals for review times of new drugs in the EU, many drugs become available in the U.S. prior to the EU, according to a study by the Tufts Center for the Study of Drug Development (Tufts CSDD). The study found that mean approval times for new products approved in both the EU and the U.S. during 2000-05 were almost the same: 15.8 months for EMEA approved products and 15.7 months for those approved by the FDA.
Recently enacted EMEA regulations such as conditional marketing authorization and accelerated assessments, which are in line with FDA initiatives, helped the agency to meet its timeline goals for all product categories for each approval stage, according to the study.
"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 program and marketing strategy," said Tufts CSDD director Kenneth I. Kaitin. He added, "Looking ahead, 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 study also found that for 71 products approved by both the FDA and EMEA, the FDA acted faster in 47 of the cases. Also, while the FDA approved more products faster than the EMEA during 2000-05, there was greater variability in FDA approval review times. The EMEA regulatory designation doesn't seem to have as much impact as it does in the U.S., 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 U.S. were similar to those for non-orphan products in the same region.
Recently enacted EMEA regulations such as conditional marketing authorization and accelerated assessments, which are in line with FDA initiatives, helped the agency to meet its timeline goals for all product categories for each approval stage, according to the study.
"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 program and marketing strategy," said Tufts CSDD director Kenneth I. Kaitin. He added, "Looking ahead, 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 study also found that for 71 products approved by both the FDA and EMEA, the FDA acted faster in 47 of the cases. Also, while the FDA approved more products faster than the EMEA during 2000-05, there was greater variability in FDA approval review times. The EMEA regulatory designation doesn't seem to have as much impact as it does in the U.S., 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 U.S. were similar to those for non-orphan products in the same region.