26. January 2023

Who can approve pharmaceuticals?


In order to have a pharmaceutical approved, an evaluation by the European Medicines Agency (EMA) is required. As an agency of the European Union domiciled in London, it is responsible for assessing and monitoring pharmaceuticals (http://www.ema.europa.eu). Therefore, the EMA plays a key role in the marketing authorisation of pharmaceuticals.

Since it is responsible for maintaining and promoting public health in the European Union (EU), it coordinates the monitoring and evaluation of all pharmaceuticals for human and veterinary use on an ongoing basis. In doing so, it utilises scientific resources from the national medicines authorities. These comprise the 31 Member States of the European Union and the countries of the European Economic Area (EEA). 

Based on the scientific assessments of the EMA, the European Commission issues either a positive or a negative decision on the applications for marketing authorisation filed by pharmaceutical manufacturers. In case of decentralised application procedures, the EMA assumes the role of a mediation body if the authorities of the EU/EEA countries involved are unable to agree on the evaluation of the pharmaceutical.

The Federal Office for Safety in Health Care (BASG) is responsible for issuing marketing authorisations in Austria (http://www.basg.gv.at). The marketing authorisation ensures a balance between a pharmaceutical’s efficacy and safety and guarantees that any information required for the treatment is provided to the user.