Voices concerns that proposed rules would not give pharma companies sufficient flexibility
The European Federation of Pharmaceutical Industries & Associations (EFPIA) has recommended changes to new draft guidance prepared by the European Medicines Agency (EMA) on reporting adverse reactions during medicine assessments.
The EFPIA is concerned that the current proposed rules would not give pharma companies sufficient flexibility to report adverse reactions that were beyond the formal focus of a medicine safety study.
In a public consultation staged by the EMA, the EFPIA noted that 'over-reporting of adverse events by investigators is common in non-interventional studies', with pharmaceutical companies receiving valid individual case safety reports (ICSRs) from investigators 'that should not have been forwarded according to the study protocol'.
The EFPIA argued that under EMA’s proposed wording, such valid ICSRs would not be reported. It has proposed changes to the guidance that would 'allow this flexibility', and which would 'would greatly reduce administrative burden for companies'. However, such problems 'should only be summarised in the interim or final study report'.