EMA and European Chemicals Agency Strengthen Collaboration
PTSM: Pharmaceutical Technology Sourcing and Management
EMA and ECHA sign agreement to share information and work together on risk assessments.
The European Medicines Agency (EMA) and the European Chemicals Agency (ECHA) have entered into an agreement to strengthen the scientific dialogue between the two organizations through sharing expertise and scientific data between their scientific committees, working groups, and panels on matters of common interest.
The working agreement, signed by EMA Executive Director Guido Rasi and ECHA Executive Director Geert Dancet, outlines activities to ensure the best use of available resources and ensure coherence in scientific opinions. The organizations agree to exchange information regarding evaluation and authorization/restriction of chemicals, as relevant for the activities of EMA; share information concerning risk management through classification, labeling, and packaging of substances; cooperate on toxicological assessments by predictive methods and new methodologies; cooperate on biocides; exchange information on environmental risk assessment for both human and veterinary medicinal products and ecotoxicology; and participate in meetings and joint projects.
Source: European Medicines Agency
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
