New pharmacovigilance legislation comes into operation
Better protection of public health through strengthened EU system for medicines safety
04-Jul-2012
- United Kingdom
- Establishment of a new scientific committee, the Pharmacovigilance Risk Assessment Committee (PRAC).
- Clarification of the roles and responsibilities of all actors involved in the monitoring of the safety and efficacy of medicines in Europe and strengthened coordination, leading to more robust and rapid EU decision-making.
- Engagement of patients and healthcare professionals in the regulatory process, including direct consumer reporting of suspected adverse drug events.
- Improved collection of key information on medicines, e.g. through risk-proportionate, mandatory post-authorisation safety and efficacy studies.
- More transparency and better communication, including publication of agendas and minutes of the PRAC and the possibility to hold public hearings.
The Agency is ready for the first meeting of the PRAC on 19 and 20 July 2012. All Member States have nominated their members. The European Commission has appointed six independent scientific experts who will also serve as members. The nomination of PRAC members representing patients and healthcare professionals will follow a new public call for expressions of interest.
Most read news
Other news from the department politics & laws
Get the life science industry in your inbox
From now on, don't miss a thing: Our newsletter for biotechnology, pharma and life sciences brings you up to date every Tuesday and Thursday. The latest industry news, product highlights and innovations - compact and easy to understand in your inbox. Researched by us so you don't have to.