17/18 March 2021
The European Medicines Agency EMA has published the revised Guidance to Applicants "Qualification of novel methodologies for drug development" (EMA/CHMP/SAWP/72894/2008). This guidance has already been finally agreed by CHMP in early 2009 and has now been revised for the second time. What's new is mainly the inclusion of the dates and deadlines for submission of letters of intent for qualification of novel methodologies.
The qualification process described in the document addresses innovative drug development methods and tools in pharmaceuticals R&D and compromises the whole procedure: