The first revision of the ERA guideline on environmental risk assessment
by Giuliana Miglierini It took eight years before revision 1 of the EMA guideline on environmental risk assessment…
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 ICMRA collaborative hybrid inspection pilot (CHIP)
by Giuliana Miglierini Hybrid inspections emerged during the pandemic as a new way to approach the assessment of…
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…
Swissmedic’s technical interpretation of Annex 1
by Giuliana Miglierini New insights on the interpretation of the new Annex 1 to Good manufacturing practices (GMPs)…
The current status of the transition to the MDR and IVDR regulations
by Giuliana Miglierini As the term to apply for the certification of medical devices and in vitro diagnostics…