EU: First Four EUDAMED Modules Mandatory from 28 May 2026

Since the unexpected discovery of N-nitrosamines in sartans in 2018, what began as isolated recalls has evolved into a permanent, lifecycle-wide compliance challenge for the pharmaceutical industry. With tightening EMA and FDA expectations, substance-specific limits, and intensified GMP scrutiny, companies must now proactively control nitrosamine risks.

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.