News Briefs - January 2005

French pharmaceutical industry association LEEM (Les Entreprises du Medicament) has proposed a strategy to enable France to exploit the growing market for biological drugs. The organisation has suggested that until 2015, France's Agence Nationale de la Recherche should spend 60% of its e1bn annual budget on life sciences, nano- and biotechnology. It wants the French government to establish two or three biotechnology centres of excellence in France, create a national fund for the first clinical trials of French biopharmaceuticals, spend aid creating bio-manufacturing plants, and a national strategy to boost recruitment and training in the biotech sector. Link 1

The European Commission has proposed allowing fast-track conditional marketing authorisations for medicines treating serious, chronic or life-threatening diseases. Its tabled regulation also covers designated orphan drugs and medicines for emergency situations recognised by the EU or the WHO. It includes rules on renewing authorisations and insisting packaging declares these medicines are conditionally approved, Link 2.

EMEA has released a discussion paper on how health-related quality-of-life policies should impact on assessing medicine, Link 3. It has also released proposed reforms to guidance on clinical investigations into medicines for acute respiratory distress syndrome, Link 4. And it has published notes on the electronic transfer of case safety and medicinal product pharmacovigilance reports, Link 5.