EMA Guidance: Good Pharmacovigilance Practices (GVP)

The European Medicines Agency (EMA) has recently updated their page and associated guidances with respect to Good Pharmacovigilance Practices (GVP), to ensure the safety and efficacy of medicinal products post-authorization. This comprehensive guideline provides a framework for monitoring and managing the risks associated with pharmaceuticals, ensuring the protection of public health.

Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP applies to marketing-authorisation holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level.

The guideline on GVP is divided into chapters that fall into two categories:

• Modules covering major pharmacovigilance processes: GVP modules I to XVI cover major pharmacovigilance processes and the development

• Product- or population-specific considerations: These chapters are available for vaccines, biological medicinal products and the pediatric population. 

A risk management system is a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to a medicinal product, including the assessment of the effectiveness of those activities and interventions, and is described in the risk management plan (RMP) of the product.

The recent updates and the new guidances are

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final revision 3 of Module XVI on risk minimisation measures and its Addendum II on their effectiveness evaluation, and revision 5 of Annex I on definitions

This guidance on good pharmacovigilance practices (GVP) gives the complete overview of Legal basis, scope and process for GVP, Maintenance and further development of GVP, Structure of GVP, etc.

Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures (Rev 3)

For a medicinal product to be granted and maintained its marketing authorisation, it must maintain a positive risk-benefit balance. The objectives of ensuring the safe use of a medicinal product and minimising risks, including their adverse health outcomes, are facilitated by risk minimisation measures (RMM).

Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum II – Methods for evaluating effectiveness of risk minimisation measures

This Addendum to GVP Module XVI provides additional guidance to be followed by marketing authorisation holders and competent authorities on data sources and methods for monitoring outcomes of risk minimisation measures (RMM) in line with the guidance on RMM effectiveness evaluation in GVP Module XVI.

Find the definitions associated with good pharmacovigilance practices in the "Annex I - Definitions (Rev. 5)"guidance and the form in "Proposed invented name(s) request form for human medicinal products".

By adhering to GVP, pharmaceutical companies can effectively monitor the safety of their products, ensuring that they provide maximum benefits to patients while minimizing potential risks. For more detailed information, refer to the full EMA Guidance on Good Pharmacovigilance Practices (GVP).