The Belgian Centre for Pharmacovigilance for medicines for Human use (BCPH), that is part of the FAMHP, is responsible for the coordination of different tasks related to pharmacovigilance:
- Collecting pharmacovigilance data: the BCPH receives both individual reports and compilations of data concerning adverse effects of medicines. This requires the collaboration of healthcare professionals, marketing authorization holders and research centres conducting clinical studies with medicines.
- Evaluating the pharmacovigilance data.
- If required after evaluation of the data, taking action.
The BCPH is part of a European network of pharmacovigilance, called Eudravigilance. The BCPH takes part in the evaluation of pharmacovigilance data for medicines that are authorized through a European procedure.
There is a direct collaboration in terms of pharmacovigilance between the different Member States in the European Economic Space via the Pharmacovigilance Working Party, a working group of representatives of all the Member States, that is part of the European Medicines Agency (EMA) based in London.
Whenever a serious pharmacovigilance problem arises in Europe or elsewhere:
- a European procedure allows the medicine to be evaluated globally;
- a restricting decision can be made for all the Member States;
- the information can be distributed more quickly.
This network, enabling reports of adverse effects to be transmitted electronically on a European level, contributes to a faster detection, evaluation and measure-taking which are necessary to respond to safety concerns for medicines, from their development to the time they are used by the patient.
The main tasks of the BCPH are:
- collecting and evaluating individual reports of adverse effects coming from healthcare professionals and marketing authorization holders;
- collecting and evaluating periodic safety reports;
- collecting and evaluating reports about the safety of patients during clinical trials involving medicines authorized in Belgium;
- participating in European pharmacovigilance activities;
- distributing information about pharmacovigilance to the healthcare professionals and the general public;
- implementing the proposed measures following the evaluation of the pharmacovigilance data;
- evaluating risk management plans and pharmacovigilance systems.