Integrated Management System

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Quality management practices are an integral part of the European Medicines Agency’s governance structure and its business processes. These practices help to ensure that the Agency operates to consistently high levels of quality, efficiency and cost-effectiveness.

Integrated quality management system

The Agency operates an integrated quality management system to ensure its compliance with the requirements of:

  • Quality Policy;
  • the regulatory framework;
  • the Agency’s Financial Regulation;
  • the internal control standards;
  • the Staff Regulations.

Benchmarking of European medicines agencies (BEMA)

The Heads of European Medicines Agencies have established a benchmarking exercise "to contribute to the development of a world-class pharmaceutical regulatory system, based on a network of agencies, operating to best practice standards." The benchmarking of European medicines agencies is based on a self-assessment by each agency against a set of questions in four areas: organisation and management; assessment of marketing authorisation applications; pharmacovigilance and inspections. Following the self-assessment, peer reviewers from other Member States conduct an independent assessment of the agency concerned, and compile a report on the strengths/best practices of the agency, as well as on areas for further improvement. Reports from all the visited agencies are entered into a database, which forms a valuable resource for best practice across the entire EU/EEA network of medicines agencies. The European Medicine Agency participate fully in this exercise.

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