EU: New Regulation on Substances of Human Origin (SoHO)

EMA and PIC/S have published a concept paper announcing a targeted revision of Annex 6 Manufacture of Medicinal Gases of the EU GMP Guide. The last update dates from 2010. The revision aims to reflect current manufacturing practice, technological progress and lessons learned from the COVID-19 pandemic.

EMA and PIC/S have published a concept paper outlining a targeted revision of Annex 15 (Qualification and Validation).

The pharmaceutical industry in Germany and other countries, too, faces considerable challenges in the area of human resource management. These problems have far-reaching implications for the competitiveness and innovative power of the industry.

The EMA has published a new reflection paper outlining its current thinking on the qualification of non-mutagenic impurities (NMIs). The paper addresses recommended approaches for evaluating the safety of new or increased impurity levels, particularly when such impurities exceed the ICH Q3A/Q3B qualification thresholds and are identified after completion of non-clinical toxicology studies.