Press Announcements

The call by the German Robert Koch-Institute (RKI) as well as other institutions in the field of disease surveillance and prevention to reduce social contacts in the private, professional and public environment and to recduce travel activities also has consequences for ECA events.

On 20 February 2020 the European Commission published the final draft of the EU GMP Annex 1. The previous draft had been published after a fundamental revision end of 2017 - and had resulted in more than 6,000 comments. This is why the European Commission will proceed differently with the Final Draft of Annex 1. Read more about the upcoming Stakeholder Consultation

GMP legislation and guidelines are occasionally not very specific. The pharmaceutical industry is seeking more concrete interpretations, though, especially coming from regulators. Such an example is the guide "Aide memoire Qualification and Validation - Basic Requirements" for inspectors.

Since EU authorities were notified about the presence of N-nitrosodimethylamine in Valsartan batches of a Chinese API manufacturer in June 2018, more and more cases of drug substance and drug product batches contaminated with Nitrosamines have come up. Consequently there is a need to discuss all relevant aspects of risk mitigation with respect to potential Nitrosamine contamination in drug substances and drug products