On 16 September 2014, new revisions to the European Medicines Agency (“EMA”) guidance on good pharmacovigilance practices came into effect.

The EMA provides guidance on good pharmacovigilance practices (“GVP”) to facilitate the performance of pharmacovigilance in the European Union (“EU”). They apply to marketing authorisation holders, the EMA and competent authorities in EU Member States. The GVP are divided into modules, each providing guidance on a distinct area of pharmacovigilance. This week new revisions to Module III on Pharmacovigilance Inspections and Module VI on Management and Reporting of Adverse Reactions to Medicinal Products came into effect.

Module III – Pharmacovigilance Inspections

GVP Module III provides guidance on the planning, conduct, reporting and follow-up of pharmacovigilance inspections in the EU. It outlines the roles of the different parties involved. Competent authorities of EU Member States, in cooperation with the EMA, conduct pharmacovigilance inspections to:

  • Determine that the marketing authorisation holder has personnel, systems and facilities in place to meet their pharmacovigilance obligations;
  • Identify, record and address non-compliance which may pose a risk to public health; and
  • Use the inspection results as a basis for enforcement action.

Pharmacovigilance inspections should be planned, coordinated, conducted, reported on, followed-up and documented in accordance with EU agreed inspection procedures. GVP Module III has now been updated to include reference to the new EU procedure on the coordination of pharmacovigilance inspections, which came into effect on 1 June 2014. The new procedure on the coordination of inspections describes different EU inspection programmes and other procedures for EU pharmacovigilance inspections.

Module VI – Management and Reporting of Adverse Reactions to Medicinal Products

GVP Module VI provides guidance on the collection, data management and reporting of suspected adverse reactions associated with medicinal products for human use authorised in the EU.

GVP Module VI has been revised to provide clarification on the clock start for reporting valid case reports and on the handling of languages in case reports. The revisions include additional guidance on reporting from post-authorisation safety studies.

Additional GVP Modules

The EMA continues to develop additional modules on GVP. The remaining modules are expected to be published in late 2014/early 2015 and will cover:

  • Public participation in pharmacovigilance;
  • Continuous pharmacovigilance, on-going benefit-risk evaluation, regulatory action and planning of public communication; and
  • International cooperation.