The EU pharmacovigilance system

Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines. It is a key public health function.

 

General Information 

Major developments

 

 

General Information 

Pharmacovigilance comprises:

• Collecting and managing data on the safety of medicines
• Looking at the data to detect 'signals' (any new or changing safety issue)
• Evaluating the data and making decisions with regard to safety issues
• Acting to protect public health (including regulatory action)
• Communicating with stakeholders
• Audit, both of the outcomes of action taken and of the key processes involved.

Those directly involved in pharmacovigilance include:

• Patients as the users of medicines
• Doctors, pharmacists, nurses and all other health care professionals working with medicines
• Regulatory authorities, including the EMA and those in the Member States responsible for monitoring the safety of medicines
• Pharmaceutical companies and companies importing or distributing medicines.

The legal framework

The legal framework of pharmacovigilance for drugs marketed within the EU is provided for in Regulation (EC) No 726/2004 with respect to centrally authorised medicinal products and in Directive 2001/83/EC with respect to nationally authorised medicinal products (including those authorised through the mutual recognition and decentralised systems).

In addition, detailed guidelines, definitions, standards and information regarding the precise execution of pharmacovigilance-related procedures are to be found in a number of guidance documents, principally Volume 9A of, "The rules governing medicinal products in the European Union - Pharmacovigilance" and in the pharmacovigilance-related guidelines of ICH (E2 series).

Volume 9 of, "The rules governing medicinal products in the European Union" contains pharmacovigilance guidelines for medicinal products both for human and for veterinary use.

These basic legal texts are supplemented by Commission Regulation (EEC) 540/95, which regulates the procedures concerning "suspected unexpected non-serious adverse reactions".

Latest developments (January 2011)

Following adoption by the Council and the European Parliament, the new legislation on pharmacovigilance was published on 31 December 2010 in the Official Journal of the EU .
The new legislation, a Regulation(819 KB)  български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) Gaeilge (ga) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv) and a Directive(997 KB)  български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv) , will become applicable in July 2012 : see Eudralex volume 1 >>>

This legislation is the outcome of the legal proposals on pharmacovigilance that the Commission put forward in December 2008. The new legislation will strengthen and rationalise the current system for monitoring the safety of medicines on the European market. The strengthened legislation on Pharmacovigilance will improve patient safety and public health through better prevention, detection and assessment of adverse reactions to medicines. It will also allow patients to report adverse drug reactions directly to the competent authorities. Additionally, reporting of adverse reactions will be broadened to cover, for example, medication errors and overdose.

Why do we need to improve the EU's pharmacovigilance system?
Pharmacovigilance is a key public health function and there is a need to strive to ensure it is optimally effective. The current system of pharmacovigilance in the EU is complex and there is potential for duplication of effort, as well as the potential for confusion of responsibilities. This is particularly true now with the introduction of innovative products, some utilising innovative technologies. Furthermore, with globalisation of the pharmaceutical market, products often enter different global markets simultaneously, with the exposure of large numbers of patients occurring in a short period of time.

Our society is changing and the expectations of EU citizens are also changing. There is a need to ensure that our pharmacovigilance systems are robust but also transparent, and we need to consider the appropriate level of involvement in the system of different stakeholders, including health care professionals and patients.

Although evolving over time, the current system of pharmacovigilance in the EU has been established for a number of years and it is an appropriate time to improve it.

How will the new Pharmacovigilance legislation ensure greater patient safety?
The new Regulation and Directive on Pharmacovigilance:

• Set out clear tasks and responsibilities for all parties involved in the EU pharmacovigilance system (Member States, marketing authorisation holders and the European Medicines Agency).
• Improve decision-making procedures and use resources more efficiently.
• Manage risk proactively and proportionately, avoiding unnecessary administrative burden and providing for a stronger link between safety assessments and regulatory action.
• Involve stakeholders in pharmacovigilance, including through direct patient reporting of suspected Adverse drug reactions.
• Strengthen communication and transparency on medicine safety.
• Strengthen companies’ pharmacovigilance systems.
• Ensure the proactive and proportionate collection of high quality data.

Questions & Answers >>(17 KB)

• Pharmacovigilance - Major developments