The draft of Guideline on Detection and Management of Duplicate Individual Cases and Individual Safety Reports (ICSRs) was released by the EMA for consultation today, 29th June 2010. The consultation period will end on 29th September 2010 and the guideline will be implemented.

the European Ombudsman has requested EMA to review its transparency policy so that it allows the public to access serious drug adverse reaction reports. This in response to a complaint by an Irish citizen, who approached the EMA in April 2008 seeking access to all suspected serious adverse reaction reports relating to the anti-acne drug… Link