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On September 15, 2014, the EMA published proposals on changes to the Good Pharmacovigilance (PV) Practices covering revisions of Module VI on the management and reporting of adverse reactions In particular post-authorisation safety studies and on Module III on new Union procedures for pharmacovigilance inspections.

There is a request for public comment.

In a guideline accompanying the proposed revisions, the EMA summarizes the history of the modules and defines PV and how it is done. Of note, they describe the increasing PV roles of healthcare professionals (HCPs) and the public in addition to the roles played by the EMA, member states and Marketing Authorisation holders (companies). They note that in the past, the main role for HCPs was spontaneous reporting of suspected adverse reactions (SARs). The roles of the public and HCPs are now being expanded to include reporting by patients of SARs (which has been commonplace in the US and Canada for many years), participation by patient and HCP representatives on the Pharmacovigilance and Risk Assessment Committee (PRAC) and attending public hearings on PV and benefit risk issues.

Module III- PV Inspections contains revisions relating to the new Union procedures for inspections (Section III.B.5). These changes occur in the section describing the inspection process developed and implemented by the PV Inspections Working Group and covers the methodology of the EMA and the member states in developing harmonization of inspection conduct, joint inspections, training and sharing of inspection results. The issues covered include:

Module VI – Management and reporting ARs was revised in July and then again in September 2014. The revisions came into effect September 16, 2014 and cover several areas. The important ones are:

There are some other changes regarding language of cases and a table in appendix 3.1.1. The reader should refer to these sections to be sure that current systems in place in the MAH are consistent with these new requirements.


These changes are relatively minor and consist of clarification of solicited reports primarily. Most MAHs or companies handling cases for EU reporting should have systems in place which already meet these requirements or which will require small adaptations to meet the new requirements. Nonetheless, personnel involved in case processing should carefully reread this document (which runs 90 pages) to be sure they have the appropriate procedures in place.

Note that in comparison to the US, Canada and some other countries, the rules and regulations in place in the EU and the member states are far more detailed and complex. This seems to reflect a philosophic difference on how drug safety is handled in different geographic areas. Whether we will return to more harmonized systems and procedures remains to be seen, but the trend seems to be away from harmonization.

Finally, if you have any comments, by all means send them to the EMA!


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