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Tag Archives: EU pharmacovigilance

The EMA has adopted new guidelines on good pharmacovigilance practices in paediatric populations

Introduction The EMA Good Pharmacovigilance Practices consist of several chapters of the Notice to Applicants that are regularly updated. A new GVP Considerations Chapter (IV) regarding specific considerations for the paediatric population came into effect on 8 November 2018. The Considerations Chapter addressed pharmacovigilance issues that frequently arise with the paediatric population and related pharmacovigilance

EMA Adopts new Chapter to its Guidelines on Good Pharmacovigilance Practices concerning Biological Medicinal Products

The European Medicines Agency (“EMA”) has adopted a new chapter to its guidelines on good pharmacovigilance practices (“GVP”). The new chapter addresses the specific challenges of pharmacovigilance relating to biological medicinal products. The chapter entitled “Product- or population-specific considerations II: Biological medicinal products” (“the Chapter”) came into effect on 16 August 2016.

EMA Publishes New Union Procedure on the Management of Pharmacovigilance Inspection Findings

On 20 June 2014, the European Medicines Agency (hereafter “EMA”) published a new European Union procedure on the management of pharmacovigilance inspection findings which may impact the robustness of the benefit-risk profile of the concerned medicinal products (“new EU Procedure”). The new EU Procedure came into effect on 1 June 2014.

One of the aims of the new European Union (“EU”) pharmacovigilance legislation, which entered into force on 28 October 2013, is to reinforce the harmonization of pharmacovigilance inspections in the EU. Furthermore, the new legislation aims to enhance cooperation among the relevant individuals and entities involved in pharmacovigilance inspections. These include the inspectors, the pharmacovigilance assessors in the EU Member States, the Pharmacovigilance Inspectors Working Group and the Pharmacovigilance Risk Assessment Committee (“PRAC”).

EMA CLARIFIES NEW VARIATION CLASSIFICATION CATEGORIES

On 10 February 2014, the European Medicines Agency (“EMA”) published a revised Questions & Answers document. The document supports the implementation of the European Commission Guidelines on the details of the various categories of variations (“Variations Guidelines“). The aim of the document is to address questions that marketing authorisation holders may have in relation to the