Consultation on the revision of the Guideline on the chemistry of active substances
The public consultation on the draft Guideline on the chemistry of active substances is open until 31 December…
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…