European Council’s recommendations on R&I
by Giuliana Miglierini The end of 2023 saw some steps forward to better support the European framework on…
EC Communication (part 2): a Critical Medicines Alliance to support European pharma supply chain
by Giuliana Miglierini After last week’s examination of the first part of the Commission’s Communication, specifically targeted to…
EC Communication (part 1): How to address critical medicines shortages
by Giuliana Miglierini As announced on 3 October in the speech given by Commissioner Stella Kyriakides at European…
Current inspection trends and new approaches to the monitoring of post-inspection activities
by Giuliana Miglierini The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published its Annual Regulatory GMP/GDP…
Revision of the CDMh’s Q&As document on nitrosamine impurities
by Giuliana Miglierini The review process of medicinal products started in 2018 to assess the presence of nitrosamine…