The Pharmaceutical Journal
Vol 268 No 7193 p487-492
13 April 2002

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European Agency for the Evaluation of Medicinal Products (EMEA) (www.emea.eu.int)

EMEA seeks more funds for drug safety work and new database

The European Agency for the Evaluation of Medicinal Products is seeking a €24m (£15m) increase in its budget to pay for increased pharmacovigilance work, including a new computerised drug safety system.

A spokesman for the EMEA told The Journal that the agency was placing additional emphasis on its pharmacovigilance work.

Revised guidance (PDF* 160K, requires Acrobat Reader version 5 or later) for marketing authorisation holders issued earlier this year stressed the need for companies to have appropriate systems for monitoring the safety of their products in place and for notifying regulatory agencies and health care professionals of any changes to the risk/benefit profile of products. "Any evidence of failure to notify such changes will result in consideration of enforcement action by competent authorities," the guidance says. Such action could include additional inspections or the public naming of non-compliant companies or prosecutions of companies and their directors, managers or qualified persons.

The EMEA is establishing a Europe-wide computerised pharmacovigilance system that will link manufacturers, national authorities and the EMEA. This will standardise the way in which information is entered into the database.

The EMEA hopes that the new system will allow earlier detection of problems with products after they are first launched. A pilot scheme is under way with six pharmaceutical companies. If the EMEA's budget application is approved by the European Commission, then the system could be working within two years. Data will be retrospectively entered into the system back to 1995.