EMA - 2010 PHARMACOVIGILANCE LEGISLATION: STRENGTHENING THE MONITORING OF MEDICINES
New pharmacovigilance legislation (a directive
http://bit.ly/km6vR4 and a
regulation
http://bit.ly/lESdv0 ) amending existing legislation was adopted
in the European Union (EU) in December 2010. The legislation aims to save
lives by strengthening the European-wide system for monitoring the safety of
medicines. For more detailed information, please see 2010 pharmacovigilance
legislation: strengthening the monitoring of medicines
http://bit.ly/jG5OaC)
On 15 April 2011 the EMA held the first stakeholder forum on the
implementation of the new 2010 pharmacovigilance legislation
http://bit.ly/il4Dl5 . The meeting involved a broad cross-section of
participants including industry, patient and healthcare professional
representatives and national medicines regulatory authorities. This was the
first in a series of stakeholder meetings taking place during 2011 and 2012
where the Agency aims to raise awareness of the requirements of the new
legislation and promote the exchange of ideas, concerns and opinions. During
the meeting, immediate feedback from stakeholders was received mainly in
relation to the Agency's and Member States' technical contribution to draft
European Commission implementing measures.
For more information, see the first stakeholder forum on the implementation
of the new 2010 pharmacovigilance legislation
http://bit.ly/lehBEM .
Reference: European Medicines Agency
http://www.ema.europa.eu/ema/index.jsp?curl=/pages/home/Home_Page.jsp
