Mark A. Ainsworth & Sinan B. Sarac:
Approval of new medicinal products – administrative procedures
Ugeskr Læger 2019;181: V10180677
In this review, we discuss the approval of new medicinal products in Europe, which in particular for products with a new active substance is increasingly being approved through formalised collaboration between the member states of the European Union. The collaboration has resulted in a strengthening and harmonisation of the administrative procedures leading to approval of new medicinal products.