Innovative medicines: new regulatory procedures for the third millennium

Expert Opin Biol Ther. 2015;15 Suppl 1:S5-8. doi: 10.1517/14712598.2015.1026322. Epub 2015 Mar 16.


Despite tremendous progress in science and increasing investment in research and development, patients' access to innovative medicines remains limited. This is in part due to increasing regulatory requirements for product authorisation and cost-constrained national health systems. At the European Medicines Agency (EMA), we have tried to address these constraints by adapting our organisation and activities to changing business models, new technologies, and the current and emerging health needs in Europe. The main EMA initiatives to provide patients with effective, safe and affordable medicines are reviewed.

Keywords: European Medicines Agency; adaptive licensing; clinical trials; health technology assessment; innovative medicines; transparency.

Publication types

  • Editorial

MeSH terms

  • Drug Discovery / legislation & jurisprudence
  • Drug Discovery / trends*
  • Drug and Narcotic Control / legislation & jurisprudence
  • Drug and Narcotic Control / trends*
  • Europe
  • Humans
  • Inventions / legislation & jurisprudence
  • Inventions / trends*