EU pharmacovigilance needs strengthening, says Commission
The European Commission has claimed that a review of the current EU systems for monitoring the safety of medicines has uncovered concerns that it needs 'rationalisation and strengthening'.
The European Commission has claimed that a review of the current EU systems for monitoring the safety of medicines has uncovered concerns that it needs 'rationalisation and strengthening'.
A Brussels assessment said: 'The current EU legal framework is complex and duplicative and there is a need to clarify roles and responsibilities.' As a result, EU industry Commissioner Guenter Verheugen has announced a forthcoming package of reforms, which should be tabled in early 2008.
These will include:
- More transparency over pharmacovigilence data and reporting;
- Clear EU standards for safety assessments by both the industry and regulators;
- Clarifying the division of responsibilities between the European Medicines Agency (EMEA) and EU member states; and
- Imposing a clear EU responsibility to conduct post-authorisation safety studies.