The pharmaceutical company generally applies for market approval for its medicine through the central procedure in the EU. During the approval process, the medicine’s effects, safety and quality are evaluated. The benefit of a medicine must outweigh the risk.

The application for marketing authorisation is made to the European Medicines Agency EMA.

In the evaluation of pharmaceuticals for marketing approval, there is usually no assessment of the benefit of the new pharmaceutical compared to other treatments for the same medical condition, nor of the benefit in relation to the cost.

Statement from the CHMP

The scientific committee (CHMP) usually takes nine months to issue an opinion from the date of application. The formal approval for marketing is then given by the European Commission within a further three months, for a total of approximately 12 months after the application.

In the national joint introduction of new medicines, a positive opinion from the CHMP is the starting point for working on the health economic evaluation and, for example, preparation of follow-up.