Posted by Michael Wonder on 10 Apr 2017
Reporting irregularities that may affect medicines
10 April 2017 - EMA Board adopts new policy on handling information on alleged improprieties from external sources.
The EMA's Management Board has adopted a new policy on how EMA handles allegations of improprieties received from external parties. These improprieties may include allegations of departures from standards of good practices that could have an impact on the evaluation and supervision of medicines.
The goal is to create an environment where individuals from outside the Agency feel confident to raise their concerns on improprieties in their area of work. The policy helps EMA assess these reports and co-ordinate any further investigation in a structured way, while protecting the confidentiality of the reporter.
Since 2013, EMA has received a total of 43 reports that relate, for example, to the manufacturing of medicines or the conduct of clinical trials. Although no formal policy has existed until now, all reports were dealt with in line with the principles included in the new policy.
