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The new pharmacovigilance legislation of 2012

The new pharmacovigilance legislation, which came 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, as well as for patients, healthcare professionals and regulators.


Background to the pharmacovigilance legislation

The development of the pharmacovigilance legislation was 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.

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 impacts on 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.

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 sufficient information on a product's quality, safety and efficacy 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.

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