Medicines regulation

Medicines regulation is a system that promotes and protects public health. It applies scientific knowledge and is based on national and international laws, to prevent the use of medicines that do not work, are of poor quality, and/or that may be harmful.

Systems vary around the world but generally medicines regulation aims to:

  • Assess the safety, efficacy and quality of medicines, and issue marketing authorisations.
  • License and monitor manufacturers and dispensers of medicines.
  • Monitor the quality of medicines.
  • Monitor the safety of medicines under development and in general use including collecting and analysing adverse reaction reports.
  • Provide independent information on medicines to professionals and the public.

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