EU Regulators Look to Harmonize Inspection Practices in Wake of Pharmacovigilance Legislation

Posted 14 March 2013 | By Alexander Gaffney, RAC 

A new work plan just published by the European Medicines Agency (EMA) for its Pharmacovigilance Inspectors Working Group (PhV IWG) places a strong emphasis on the harmonization and coordination of efforts between national authorities in the coming year, coming just as the implementation of new pharmacovigilance legislation ramps up in the EU.


Pharmacovigilance refers to efforts to keep track of a drug's safety in postmarketing settings. Because nearly all drugs are approved on the basis of testing in just a few thousand individuals, and most have not been previously marketed, the role of regulators in tracking adverse event signals after a drug's approval is seen as critical. A rare, one-in-5,000 fatal side effect might not be seen in a 2,500-person study of a drug, but could be relatively common once approved, particularly if it is widely prescribed.

Which is where the role of regulators comes into play. In 2010, the EU passed an ambitious piece of new pharmacovigilance legislation intended to better manage regulatory risks before granting approval, better understand data collected after marketing approval, grant new authority for regulators to be able to make changes to a drug and to increase risk communications to the public.

Plan Calls for Harmonization

A key part of those changes is the PhV IWG, which, along with the Pharmacovigilance Risk Assessment Committee (PRAC), is meant to conduct pharmacovigilance activities in conjunction with EU member states, of which there are 27.

Because of the number of stakeholders involved, a large part of PhV IWG's role is spent coordinating and making sure that EU member states are correctly implementing pharmacovigilance requirements. One of the overarching goals of the legislation is to get regulatory authorities to freely share safety signals with one another in the hopes of either confirming or putting to rest concerns about a particular product's safety.

To that end, the PhV IWG said it will be putting out new harmonization procedures and guidance documents meant to outline new pharmacovigilance inspection procedures, make sure those inspections are harmonized across the EU, review existing procedures for suitability and generate some product-specific guidelines for certain products such as the pandemic influenza vaccine (released in March 2013).

Other documents set to be generated by the working group include formalized risk factors that should trigger site inspections, guides on how to harmonize inspection findings through guidance, the development of methods to promote joint inspections for human and veterinary drug products, new training materials for inspectors to promote adherence to best practices for inspections and reporting, and various new question and answer guidance documents meant to help in the implementation of the pharmacovigilance legislation.

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