Pharmacovigilance legislation

Pharmacovigilance legislation was developed in a bid to significantly reduce the number of adverse drug reactions, which were found to be causing nearly 200,000 deaths per year in the EU.

The directives and regulations, which represented the biggest change to human medicine regulation in the EU since 1995, are designed to improve collection of data and provide means for rapid and robust assessment of safety issues.

For marketing authorisation holders and applicants, this results in:

  • clearer roles and responsibilities;
  • minimised duplication of effort;
  • simplified reporting procedures;
  • clarity over the legal framework for monitoring activities.

Implementation of the legislation

The pharmacovigilance legislation is accompanied by an implementing regulation, which provides operational details.

Further amendments strengthen the system, specifically by providing for prompt notification and assessment of safety issues.

The legislation created new tasks and activities for regulators and the pharmaceutical industry, which can be divided into four areas:

Collection of key information on medicines

Analysis and understanding of data and information

Regulatory action to safeguard public health

Stakeholder communication

  • Agendas and minutes of all committee meetings are published by the Agency, and public hearings on safety issues can be arranged.
  • To guarantee consistency, the Agency coordinates announcements on the safety of medicines across the EU, including nationally authorised products.
  • Stakeholder meetings: EMA hosts stakeholder forums to raise awareness of the requirements of the pharmacovigilance legislation and promote the exchange of ideas, concerns and opinions and pharmacovigilance platform meetings provide an opportunity for both a general update and more focused discussions on specific processes or issues.

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