European Union GLP Working Group - Comment

The good laboratory practice working group of the European Union (EU GLP working group) welcomes the intention of FDA to modify its good laboratory practice regulations in order to incorporate all basic elements needed for a GLP quality system consistent with internationally recognized quality systems. The EU GLP working group understands that the reference to internationally recognised quality systems relates to the OECD System for the Mutual Acceptance of Chemical Safety Data and the OECD principles of good laboratory practice. The Member States of the European Union, by transposing Directive 2004/9/EC of the European Parliament and the Council on the inspection and verification of good laboratory practice and Directive 2004/10/EC on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances, have fully incorporated the OECD principles of good laboratory practice and the revised OECD guides for compliance monitoring procedures and for the conduct of test facility inspections and study audits into their legal order. The EU GLP working group therefore asks FDA to ensure that the amendments it will propose to the regulation governing good laboratory practices (21 CFR part 58--Good Laboratory Practice for Nonclinical Laboratory Studies) will be fully in line with the OECD principles of good laboratory practice and form no obstacle to the Mutual Acceptance of Chemical Safety Data. On behalf of the EU GLP working group, ----------------------------------------------------------------------------------- Maik Schmahl European Commission Enterprise and Industry DG Unit G2: Chemicals - Classification & Labelling, Specific Products, Competitiveness B - 1049 Brussels E-mail: Entr-Chemicals@ec.europa.eu