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EU Officials OK Drug Registration System




 

BRUSSELS, Belgium - European Union health ministers gave their preliminary approval on sweeping new rules for drug approvals Monday, creating a single EU drugs agency with similar powers to the U.S. Food and Drug Administration. Under the proposal, the drug industry would be required to follow a centralized procedure to register certain drugs at the European Agency for the Evaluation of Medicinal Products (EMEA) in London, which EU officials say will make decisions faster than the FDA.

The plan will cover the approval process of drugs to fight AIDS, cancer, diabetes, and neurodegenerative diseases, such as Parkinson's Disease. For other drugs, companies could chose whether to use the EMEA or national authorities.

Now, about 40 percent of new products currently use the national route, where a drug approved in one EU country is then recognized by other European governments. Drug companies have lobbied to retain that choice.

The proposed rules go back to the European Parliament which must approve the legislation before it can be implemented. EU officials hope final approval can be reached before the end of the year.

Monday's agreement waters down earlier proposals, however, that called for all new drugs to be approved via the EMEA, though generics could still be vetted by national governments.

"With today's agreement, we have taken an important step toward ensuring the Europe gets a more robust, modern, effective and competitive regulatory framework for pharmaceuticals," said EU Enterprise Commissioner Erkki Liikanen.

Liikanen said the health ministers' decision was a "well balanced compromise."

The plan also aims to reverse the trend of many European drug companies which have shifted research activities to the United States, where the regulatory system is seen as more business friendly and less bureaucratic than in Europe.

The new rules would also standardize how long drug companies can have exclusive intellectual property rights over data generated on new medicines. Health ministers proposed 10 years plus one extra year if drug companies could show the drug had an alternative use.

European drug companies welcome the 10-year protection period but have voiced concern over having to register new drugs with an EU agency



 


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Information in this article was accurate in June 2, 2003. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.