The first Union list of critical medicines by Giuliana Miglierini The first version of the Union list of critical medicines was published on 12 December…
Reactions to the proposed ban of PFAS by Giuliana Miglierini A proposal to ban around 10,000 per- and polyfluoroalkyl substances (PFAS) was submitted in January…
EMA’s reflection paper on AI in the pharmaceutical lifecycle by Giuliana Miglierini The rapidly evolving role of artificial intelligence (AI) and its possible application in the pharmaceutical…
The new MHRA’s framework for clinical studies By Giuliana Miglierini The repositioning of the United Kingdom as a global leader for clinical development of medicinal…
Draft ICH M13A guideline on bioequivalence open for consultation By Giuliana Miglierini The draft ICH M13A harmonised guideline “Bioequivalence for immediate-release solid oral dosage forms” was endorsed…
EDQM introduces a consultation phase in the management of CEP documents by Giuliana Miglierini The new process implemented by the European Directorate for the Quality of Medicines and HealthCare…