Mark A. Ainsworth & Sinan B. Sarac:
Approval of new medicinal products – documentation requirements
Ugeskr Læger 2019;181:V10180678
In this review, we discuss the approval of new medicinal products, which particularly for new products containing a new active substance is increasingly done in collaboration between the European countries. This collaboration has strengthened and harmonised the scientific basis for approval of new drugs in the EU.