EU to Implement New Drug-Safety Requirements This Fall

Pharmaceutical companies will be required to submit mandatory adverse-event reports as well as risk management plans for their drug products under a series of broad new drug-safety requirements to be implemented by the European Union (EU) this fall.

Drafted by the European Medicines Agency (EMEA) and the Heads of Medicines Agencies (HMA), the reporting requirements will be included in new "Community" legislation that EU regulators will begin enforcing in November, the agencies announced.

"The new legislative provisions will allow for an intensive supervision of the undesirable effects of medicines in order to take appropriate regulatory action, including, where needed, a rapid withdrawal from the market of any medicinal product presenting a negative benefit/risk balance under normal conditions of use," the EMEA and the HMA said. The agencies emphasized that the new measures are not designed to slow the drug development process and won't result in an increase in regulatory data requirements during the premarket approval phase.

The Community legislation was drafted as part of the EU's broad European Risk Management Strategy (ERMS) initiative, which was launched in 2002 to enhance the EU's monitoring of drug safety. In addition to spawning the drug-safety legislation, the ERMS is focused on numerous other goals, including improving the EU's overall drug monitoring system.

To view the EU's ERMS action plan, go to http://www.mhra.gov.uk/EU_risk_action_plan.pdf (http://www.mhra.gov.uk/EU_risk_action_plan.pdf). To view the progress report on the implementation of the ERMS, go to http://www.mhra.gov.uk/EU_risk_report.pdf (http://www.mhra.gov.uk/EU_risk_report.pdf).