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SP0159 What is EMA Doing for Patients with Rheumatic Diseases
  1. R. Veselý
  1. Rheumatology, Respiratory, Gastroenterology and Immunology Office, European Medicines Agency, London, United Kingdom

Abstract

The European Medicines Agency is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. It began operating in 1995.

The mission of the European Medicines Agency is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health.

The Agency is responsible for the scientific evaluation of applications for European Union (EU) marketing authorisations for human and veterinary medicines in the centralised procedure.

Among other tasks the Agency plays a role in stimulating innovation and research in the pharmaceutical sector:

  • it gives scientific advice to companies on the development of new medicines;

  • it publishes guidelines on the requirements for the quality, safety and efficacy testing of medicines;

  • it provides special assistance to micro, small and medium-sized enterprises (SMEs) through its SME office;

  • it issues opinions on orphan designation for medicines for rare diseases;

  • it manages the Innovation Task Force, a group that provides a forum for early dialogue with applicants.

Important achievements during 20 years of history of EMA will be reviewed with focus on the most recent initiatives:

  • Authorisation of new medicinal products for treatment of rheumatic diseases in adults and in children

  • Development of scientific guidelines (RA, JIA, SLE, SpA, gout, osteoporosis)

  • Paediatric investigation plans

  • Scientific advice

  • Fostering of research

  • Patients' involvement in evaluation activities

  • International collaboration

  • Collaboration with academia

Disclosure of Interest None declared

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