BioWorld International Correspondent
BRUSSELS, Belgium - The European Union gave its definitive endorsement to faster registration for biotechnology medicines last week. After more than three years of debate, ministers from EU member states signed off on March 11 to the new framework for authorizing and monitoring new medicines on the European market.
Among its reforms, the new EU rules will provide fast-track registration for innovative new products, with even faster fast-track facilities for products that fill a gap in current therapies.
At the same time, drug companies will have less choice over how they seek authorization. More categories of medicines will be obliged to use the EU's centralized authorization procedure through the London-based European Agency for the Evaluation of Medicinal Products. The current option that allows firms to launch products nationally and later seek authorization in other member states through a mutual recognition procedure no longer will be available for treatments for AIDS, cancer, diabetes and degenerative nervous system disorders.
There also will be closer monitoring of medicines on the market so as to spot side effects earlier, and there will be more public access to information.
The European pharmaceutical industry seemed satisfied with the final stage in the long saga. The European Federation of Pharmaceutical Industries and Associations said: "Although the final compromise package does not fully meet the needs of the research-based pharmaceutical industry, it brings in important improvements in Europe's regulatory structure. Efficient regulations are essential to encourage medical research in Europe for the benefit of patients."