BioWorld International Correspondent

BRUSSELS, Belgium - The European Union is set to push up the fees for registering medicines via the European Agency for the Evaluation of Medicinal Products.

The key EU committee responsible for setting fees for using the EMEA gave its backing last week to a proposal to raise the annual fee by 26 percent, and to raise all other fees - including the charge for handling an authorization application - by 16 percent.

All biotechnology-derived medicines in Europe are required to use the EMEA system for authorization and maintenance. The increase, the first since the agency was set up in 1995, means that it will now cost €232,000 to get an initial authorization for a biotechnology-derived medicine (up from the current level of €200,000). Annual maintenance fees will rise from €20,000 to €25,200.

Three More Products Gain Orphan Designation

Three medicines were accepted as candidates for the European Union's orphan drug procedure at the February meeting of the Orphan Medicinal Products Committee of the European Agency for the Evaluation of Medicinal Products.

One of the drugs is for systemic sclerosis, one for tricyclic antidepressant poisoning and one for Pseudomonas aeruginosa infections in patients with cystic fibrosis. That brings to 140 the number of products approved as candidates since the system came into being two years ago, out of the 241 applications submitted. So far just four products have been rejected, and 67 applications have been withdrawn.

All the others remain under examination, and the EMEA has received notifications of companies' intentions to file a further 64 products. And at the end of this procedure, 129 of the 140 candidates have now been formally designated as orphan products.