Heads of Medicines Agencies [HMA]« Back to Glossary Index
« Back to Glossary Index
- Medicines regulation in EuropeMedicines 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.
- Marketing Authorisation ApplicationsThe 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.
- Falsified medicinesA 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.
- Glossary: Common European Submission Platform [CESP]
- Glossary: Coordination Group for Mutual Recognition and Decentralised procedures – human [CMDh]