1. Introduction

1. What is pharmacovigilance (PhV)?

The WHO defines PhV as: ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

The EU Commission (EC) in its Commission Staff Working Document[1] defines PhV as: ‘Pharmacovigilance is planned monitoring of the safety of medicines so that anything that affects their safety profile can be swiftly detected, assessed, and understood and appropriate measures can be taken to manage the issue and assure public health.’

Before receiving a marketing authorisation (MA) a medicine’s safety and efficacy has to be assessed and approved by the respective regulatory authority. Data are predominantly based on the results from clinical trials (usually so-called randomised controlled trials (RCT)). Trial participants (patients) are selected according to stringent inclusion and exclusion criteria and followed up very closely under controlled conditions. It follows that a medicine at the time of its authorisation, has been tested in a relatively limited number of selected patients for a defined time period. In sum, not all safety issues can be addressed or reported at the time of authorisation due to the recognized limitations of clinical trials.  In contrast, after authorisation, the medicine may be used by a heterogenous population, for a longer time, often with other concurrent diseases and other medicines, under real world conditions. This is when certain, especially rare, adverse reactions (often also called side effects, which is the common lay term)[2] may emerge.  Post authorisation however provides the opportunity to learn more about the safety of a medicine.

Therefore, continuous and careful monitoring of the safety profile of all medicines throughout their lifecycle and especially their use in everyday practice is essential in identifying and minimising risk. In the EU each marketing authorisation holder (MAH), national competent authority (NCA) and the European Medicines Agency (EMA) are under a legal obligation to operate a pharmacovigilance system. The overall EU pharmacovigilance system works through cooperation between the EU Member States, EMA and the European Commission.

[1] Commission Staff Working Document Accompanying the document Commission Report Pharmacovigilance related activities of Member States and the European Medicines Agency concerning medicinal products for human use (2012 –2014) {COM(2016) 498 final}

[2]  EUPATI will use the term ‘adverse reaction’ instead of ‘side effect’ since this is the proposed term by regulatory authorities