Giuliana Miglierini

The EU’s Competitiveness Compass and the new EU Biotech Hub

The Competitiveness Compass describes the new European Commission’s political actions to fill the gap with international competitors, support the transition to clean and digital technologies, and reduce supply chains’ dependencies in strategic sectors. Among these are also biotechnologies and more extensively, life sciences.

PIC/S’ new guidances on remote and hybrid inspections

Two new guidance published by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) discuss the different types of remote assessment, including hybrid inspections, and provide a harmonised approach to their conduct. The PIC/S also revised its guideline for the accession to the Scheme by interested regulatory agencies

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

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…