EU Commission seeks obligatory postmarketing safety studies
The European Commission is preparing a legislative proposal on pharmacovigilance that would impose a legal requirement for pharmaceutical companies to carry out postmarketing safety studies.
The European Commission is preparing a legislative proposal on pharmacovigilance that would impose a legal requirement for pharmaceutical companies to carry out postmarketing safety studies.
The Commission's planned changes to the legal framework on pharmacovigilance include the establishing of 'a clear legal requirement to conduct post-authorisation safety studies, including those in risk management systems'.
This reform, which is likely to be the subject of a legislative proposal in 2008, will also aim to clarify the respective competences of member states and the European Medicines Agency (EMEA) to avoid duplication.
The Commission, which launched a public consultation on this subject last year, says that 'the current EU legal framework is complex and duplicative and there is a need to clarify roles and responsibilities'. Member states' differing application of current pharmacovigilance rules has resulted in a system which is 'over-complicated', especially for the industry, it believes.
Improving implementation of the current system will include DG (directorate-general) enterprise and DG research working together to fund studies on medicines' safety and pharmacovigilance methods. The Commission also intends to cooperate with member states to find solutions to problems linked to administrative practices that complicate reporting rules for the industry.
The Commission also hopes to work with the EMEA to ensure maximum use of EU pharmacovigilance database Eudravigilance.
Proposals for changes to the legal framework include strengthening the rules on transparency related to pharmacovigilance data, assessment and decision-making, and involving patient and healthcare professional groups in this process.
The Commission also wants to establish 'Good Vigilance Practices' (GVPs) for industry and regulators, and to rationalise and simplify the reporting of adverse drug reactions.
DG enterprise services will carry out an impact assessment during 2007 with a view to a legal proposal in 2008.