EMEA Fee Decision Expected This Week

The European Commission's Council of Ministers was expected to reach a decision this week on the fee structure of the European Medicines Evaluation Agency for its drug approval work, the EMEA has told the marketletter. This follows the European Parliament vote in Strasbourg on January 18 to adopt the Haug report, which it refused to do at its last 1994 plenary session.

Meantime, a spokesperson for the UK Medicines Control Agency has said the UK yellow card adverse drug reaction reporting scheme is a leader in Europe, and it is vital that it continues to be effective. Susan Wood, director of the MCA's post-licensing division, said pharmacovigilence within the European Union will be based on national systems, and that the changes in the EU will add importance to the relevance of the yellow card system.

Michael Rawlins, chairman of the Committee on the Safety of Medicines, said that since the yellow card scheme began in 1964 after the thalidomide tragedy, over 300,000 reports have been submitted. About 20,000 reports are received annually, 70% from general practitioners and 25% from hospital doctors.