Comments invited on good-pharmacovigilance-practice module on reporting of adverse reactions

7 June 2013

Revision clarifies requirements for non-interventional studies

The European Medicines Agency has released a revision of the Draft guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products (Rev 1) for a two-month public consultation. GVP modules are key deliverables of the 2010 pharmacovigilance legislation. They describe the requirements in relation to pharmacovigilance in the European Union.

The revision focuses specifically on the requirements for the management and reporting of suspected adverse reactions occurring in non-interventional studies. The module currently stipulates that marketing-authorisation holders (MAHs) or academic sponsors on behalf of MAHs conducting non-interventional studies with primary data collection directly from patients, consumers or healthcare professionals should actively seek all adverse events to assess them and report cases of suspected adverse reactions to competent authorities.

Since the publication of this module, the Agency has received comments highlighting the difficulty in implementing these requirements.

In response to these comments, the Agency has revised module VI to clarify the types of adverse event that sponsors needs to seek actively:

• Non-academic sponsors should specify, in the protocol, any adverse events (serious or non-serious) to be actively sought and reported by healthcare professionals, patients or consumers in the course of the study.
• Death and fatal outcomes are events that need to be collected actively by sponsors unless they are presented in the protocol as adverse events that will not be actively sought. The justification for this exemption should always be provided.
• For adverse events actively sought according to the protocol, only valid individual case safety reports (ICSRs) of adverse reactions suspected to be related to the medicine being studied should be reported by the sponsor to the competent authorities. They should be considered as solicited reports.
• All other serious and non-serious reports of adverse events that are not actively sought according to the protocol should only be summarised in the interim or final study report. They should not be reported as ISCRs to the competent authorities.

These requirements do not apply to academic sponsors, who should follow local requirements as regards the reporting of cases of suspected adverse reactions. However, where a study is directly financed, initiated or managed, or where its design is influenced by an MAH, the MAH should fulfil the requirements detailed in GVP module VI.

The consultation period will end on 5 August 2013.