The European Medicines Agency (EMA) is the agency for the regulation of medicinal products which are distributed in the European Union. The agency is divided into four main units and one unit for administration, which reflect its functions and services. These units are:
- Human Medicines Development and Evaluation. This is the unit responsible for all activities related to medicines for human use, from the development stage to final approval, with special emphasis on safety and efficacy.
- Patient Health protection is the unit which promotes pharmacovigilance and risk management, reviewing the benefit and risk of each approved product.
- The Veterinary Medicines Unit is responsible for the authorisation of veterinary products
- Information and Communications Technology unit provides high quality and advanced infrastructure solutions to support services.
TIF is collaborating closely with EMA. In recent years, EMA promoted collaboration with our involvement of patients’ organisations in its work and activities. In this context, patient representatives from eligible organisations participate in the following committees:
- Committee for Medicinal Products for Human Use (CHMP)
- Committee for Medicinal Products for Veterinary Use (CVMP)
- Committee for Orphan Medicinal Products (COMP)
- Committee on Herbal Medicinal Products (HMPC)
- Paediatric Committee (PDCO)
- Committee for Advanced Therapies (CAT)
EMA policies:
- POLICY/0001 The European Medicines Agency's integrated quality management system
- POLICY/0004 Health and Safety
- POLICY/0009 Appropriate coordination between the Agency's scientific committees
- POLICY/0015 Scientific publications by EMA staff
- POLICY/0017 Updating of job summaries and job descriptions
- POLICY/0023 Personal business cards
- POLICY/0026 Records management
- POLICY/0029 Replies to external requests for contributions by EMA staff
- POLICY/0033 European Medicines Agency communication on (emerging) safety related issues for medicines for human use
TIF partakes in EMA activities as a member of the “Patients and Consumers’ Working Party”.
For more information, visit the website: http://www.ema.europa.eu
