CPME Rapporteur on Pharmacovigilance: Dr Christiaan KEIJZER and Dr Erszébet PODMANICZKY
CPME Secretariat : Ms Carole ROUAUD
CPME has been working on the issue of safety of medicines for many years. The revision of the Pharmacovigilance legislation has been agreed at European level in December 2010, the aim being to improve the safety of medicines at European level, mainly by strengthening the role of the European Medicines Agency (EMA) with regard to scientific evaluation and control of medicines, as well as on effective signal detection mechanisms when a medicine presents a risk to patients’ safety. CPME currently monitors the policy developments in this field.
Adopted policies include:
- CPME response to the EMA consultation on the design of web-reporting forms for healthcare professional reporting of adverse drug reactions, adopted on 15 December 2011
- CPME reaction to Commission paper Proposal for a legislation amending, as regards pharmacovigilance on the Community code relating to medicinal products for human use, adopted on 13 June 2009
- CPME reply to Public Consultation on Legislative proposals regarding a Strategy to better protect public health by strengthening and rationalizing EU Pharmacovigilance, adopted on 21 January 2008
- Suggestions to improve and strengthen the Community pharmacovigilance system, adopted on 27 October 2006
