Heads of Medicines Agencies [HMA]

Medicines regulation is the basis for ensuring that only medicines of a high quality are marketed. In Europe, the European Commission proposes high-level legislation in the form of regulations and directives. The European Medicines Agency (EMA) coordinates the development of new and revised EU scientific guidelines in working groups/parties.

The medicines development process' ultimate goal is an approval for marketing the new medicinal product – a Marketing Authorisation. This should be an integral part of all steps throughout the life-cycle of the medicinal product. A Marketing Authorisation Application contains information on quality, and non-clinical and clinical studies.

A falsified medicine is a fake that passes itself off as a real, authorised medicine but contains poor quality or falsified ingredients, no ingredients or in the wrong dose and pose a major threat to public health and patient safety.