BEBAC   Ing. Helmut Schütz

EU – EMA

Guideline on clinical development of fixed combination medicinal products

On 5 April 2017 EMA’s Committee for Medicinal Products for Human Use (CHMP) published the final (dated 23 March 2017)

This is the 2nd revision of the guideline on clinical development of fixed combination medicinal products containing two or more active substances within a single pharmaceutical form. The active substances may be authorised substances or substances that have not yet been authorised in the EU. This guideline addresses the clinical development requirements of fixed combination medicinal products, which shall reflect their intended therapeutic use and indication independent of the chosen legal basis for the submission of the marketing authorisation application.

The guideline will be effective with 1 October 2017.

BEBAC