Old drug, new clinical use, no man’s land for the indication: an awareness call from European experts

Licence holders of a new medical agent who apply for marketing authorisation in Europe have two choices: They may either apply to a national health authority (which limits authorisation to the authority’s country) or choose the centralised procedure with the European Medicines Agency (EMA) to apply for authorisation for all countries belonging to the European Union (EU) as well as Liechtenstein, Iceland and Norway. For anticancer drugs, as well as several other categories, the central authorisation approach through EMA is compulsory since 2005.