EMA Good Pharmacovigilance Practices (GVP) Guidelines

EMA Good Pharmacovigilance Practices (GVP) Guidelines: Medicines and vaccines have transformed the prevention and treatment of diseases. In addition to their benefits, medicinal products may also have side effects, some of which may be undesirable and/or unexpected.

What is Pharmacovigilance?

Medicines and vaccines have transformed the prevention and treatment of diseases. In addition to their benefits, medicinal products may also have side effects, some of which may be undesirable and/or unexpected. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. 

All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use. However, the clinical trial process involves studying these products in a relatively small number of selected individuals for a short period of time. 

After authorization the medicine may be used in a heterogenous population and large number of patients, for a long period of time and with other medicines. Certain side effects may emerge in such circumstances. It is therefore essential that the safety of all medicines is monitored throughout their use in healthcare practice.

EMA Good Pharmacovigilance Practices (GVP) Guidelines:

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Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply 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.


EMA Good Pharmacovigilance Practices (GVP) Guidelines:

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