Pharmacovigilance Working Party

The Pharmacovigilance Working Party (PhVWP) provides recommendations on matters relating to pharmacovigilance, the constant monitoring of medicinal products on the market.

This involves providing advice on the safety of medicines and on the investigation of adverse reactions associated with medicines authorised in the European Union (EU).

Since the formation of the European Medicines Agency in 1995, the PhVWP's mandate has covered two main areas, reflecting how the European pharmacovigilance system operates:

• reporting to the Committee for Medicinal Products for Human Use (CHMP) on centrally authorised medicines and on nationally authorised medicines referred to the Agency. This enables the CHMP to effectively identify, assess and manage risk at any phase in the lifecycle of a medicine;
• reporting to medicines regulatory authorities in EU Member States on nationally authorised medicines not subject to a referral procedure. For these medicines, the PhVWP acts as a discussion platform for the Member States. Its recommendations, including any recommendations for regulatory action, are not legally binding on the Member States.

The PhVWP's responsibilities include:

• evaluation of potential signals arising from spontaneous reporting;
• provision of advice on confirmation and quantification of risk and on regulatory options;
• risk management;
• monitoring regulatory action;
• setting standards for procedures and methodologies to promote good vigilance practice;
• promotion of communication and exchange of information between the Agency and national competent authorities;
• international co-operation.

Mandate, rules of procedure and work programme

More information on the PhVWP's responsibilities and composition are available in these documents:

• Mandate, objectives and rules of procedure
• Work plan

 The PhVWP publishes monthly reports summarising its activities.

Composition

The PhVWP is composed of one representative per EU Member State, as nominated by the medicines regulatory authorities in Member States, as well as two representatives of patient organisations. The CHMP can also appoint co-opted members to provide additional expertise as required. Members are selected from the list of European experts according to their expertise.

Iceland, Liechtenstein and Norway may also appoint representatives. Additional experts and observers can attend PhVWP meetings with the agreement of the Working Party's chairperson and of the Agency.

Members

Below (in alphabetical order of surname) are the current members of the PhVWP. The members' declarations of interests are available in the European expert list.