Commission streamlines rules for registration of medicines
New rules on the registration of medicines for human and veterinary use have been adopted by the European Medicines Agency (EMEA), based on proposals put forward by the European Commission. EMEA enables companies to obtain EU-wide marketing authorisation for medicinal products based on a single application, following evaluation by a committee of scientific experts. EMEA's remit also covers providing companies with advice on their research and development programmes. Under the new rules a number of fee reductions have been introduced including the evaluation of generic medicines, and the deadline for payment of fees has also been extended from 30 to 45 days. New financial and administrative incentives for small and medium sized enterprises (SMEs) are also being put forward by the Commission. On 17 November, meanwhile, EMEA issued an update on the safety of the antiviral drug Tamiflu, which is used to treat influenza in children and adults. Two cases of alleged 'suicide' associated with the treatment of influenza, involving a 17 and a 14 year-old boy, had been reported to EMEA. In a statement, EMEA said: 'So far, no causal relationship has been identified between the use of Tamiflu and psychiatric symptoms (such as hallucination or abnormal behaviour).' However, the statement added that an assessment of psychiatric events during treatment with Tamiflu is difficult because other medicines are often taken at the same time as Tamiflu, and patients with influenza and a high fever can show psychiatric symptoms. EMEA has asked the company that holds the authorisation for Tamiflu, Roche, to provide a safety review of all available data on serious psychiatric disorders, including all cases with a fatal outcome where Tamiflu was involved, and will issue a further statement on the basis of this evaluation.