null All you ever wanted to know about procedure 4 but never dared ask!

EDQM Strasbourg, France 14/01/2022
All you ever wanted to know about procedure 4 but never dared ask!

This document is intended to help stakeholders understand the advantages of applying for a monograph elaboration via procedure 4. It describes how Group P4 has elaborated P4 monographs over the last 10 years. It also applies to monographs on biotherapeutics as elaborated by the P4bio Working Party.