Fourth criterion for marketing authorisations proposed

The Parliament’s discharge report for the European Medicines Agency’s (EMA’s) finances for 2016 included a recommendation to add a fourth criterion to the three already in use by the European Medicines Agency when assessing drugs’ marketing authorisations application: added therapeutic value.

The three criteria the EMA uses to date are efficacy, quality and safety. Based on EMA’s founding regulation, “it is our understanding that this specific recommendation would require a legislative change enacted by the EU co-legislators,” an agency spokesperson said.

Dennis de Jong, a Dutch MEP said: “We need medicines that are something new completely, that really have added value”.

Source: Politico

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Published 24. April 2018 in News EU