Pharmacovigilance legislation

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The new pharmacovigilance legislation, which started to come into effect in July 2012, was the biggest change to the regulation of human medicines in the European Union (EU) since 1995. It had significant implications for applicants and holders of EU marketing authorisations.

Background to the pharmacovigilance legislation

The development of the pharmacovigilance legislation was the based on the observation that adverse drug reactions (ADRs), ‘noxious and unintended’ responses to a medicine, caused around 197,000 deaths per year in the EU.

Because of this, in 2005 the European Commission began a review of the European system of safety monitoring including sponsoring an independent study, as well as extensive public consultation through 2006 and 2007.

This process resulted in the adoption of new Directive and Regulation by the European Parliament and Council of Ministers in December 2010, bringing about significant changes in the safety monitoring of medicines across the EU:

The new legislation amended existing pharmacovigilance laws contained in Directive 2001/83/EC and Regulation (EC) No. 726/2004.

This legislation was accompanied by the implementing regulation, a legally binding act published by the European Commission in June 2012 that provides details on the operational aspects for the new legislation:

In October 2012, the pharmacovigilance legislation was further amended following review of the withdrawal of the medicine Mediator (benfluorex). The amendments aimed to further strengthen of the protection of patient health by allowing prompt notification and assessment of safety issues:

Practical measures to facilitate the performance of pharmacovigilance in accordance with the legislation are available in the guideline on good pharmacovigilance practices (GVP). GVP apply to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities in EU Member States, and cover medicines authorised centrally via the Agency as well as medicines authorised at national level.

Aims of the pharmacovigilance legislation

The pharmacovigilance legislation aims to reduce the number of ADRs in the EU. It aims to achieve this through:

  • the collection of better data on medicines and their safety;
  • rapid and robust assessment of issues related to the safety of medicines;
  • effective regulatory action to deliver safe and effective use of medicines;
  • empowerment of patients through reporting and participation;
  • increased levels of transparency and better communication.

The legislation includes significant implications for marketing-authorisation applicants and holders. It aims to:

  • make their roles and responsibilities clear;
  • minimise duplication of effort;
  • free up resources by rationalising and simplifying reporting on safety issues;
  • establish a clear legal framework for post-authorisation monitoring.

Full details on the initiatives introduced by the legislation and their implications are available on Implementation of the pharmacovigilance legislation.

Why do we need pharmacovigilance?

Many of the challenges in safety monitoring of medicines stem from the limited amount of information available from clinical trials at the time of authorisation of a medicine. Regulators have to strike a balance between making new medicines available for use in patients as early as possible and waiting until as much as possible about a medicine is known.

Patients in clinical trials are selected carefully and followed up very closely under controlled conditions.

After authorisation, however, patients using a medicine may have other diseases and may be taking other medicines. It will also be used in a larger number of patients, raising the possibility that rare side effects could start to be seen only once the medicine is being used. Some side effects may only start to emerge once a medicine has been used for a long time.

By continuing to collect information once a medicine is available and taking action in response, regulators can continue to protect the public from emerging safety issues throughout a medicine's life cycle, thereby ensuring its safe and effective use.

Role of the European Medicines Agency

The European Medicines Agency, the EU Member States and the European Commission are responsible for implementing much of the pharmacovigilance legislation. The Agency plays a key role in coordinating activities relating to the authorisation and supervision of medicines, including safety monitoring, across this network.

The Agency is working with a wide range of stakeholders including the European Commission, pharmaceutical companies, national medicines regulatory authorities, patients and healthcare professionals to ensure effective implementation. For full details on the progress of implementation of the legislation, see Implementation of the pharmacovigilance legislation.

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