Regulatory Affairs

The new European Shortages Monitoring Platform becomes mandatory

The second version of the European Shortages Monitoring Platform, to be launched on 2 February 2025, will include all functionalities to report shortage issues on a routine basis or concerning preparedness exercises or declaration of a health crisis. All the guidance needed to manage the reporting, as well as the drafting of the Shortage Prevention Plans and Shortage Mitigation Plans, is available on the EMA website

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)…