Evaluation of the Good Laboratory Practice (GLP) Directives

Cruelty Free Europe thanks for the Commission for the opportunity to provide comments on the EU GLP Directives, an invaluable tool for ensuring the quality and reliability of data used for regulatory decision-making.

Based on own academic work, analyses, and observations, in my opinion, the current implementation of GLP in the EU does not effectively prevent misleading data analyses, exclusion of datasets from study reports, and withholding of entire studies, and does not stringently follow up on bad practices when these are detected. Also, there is a lack of transparency regarding GLP violations.

Confapi, Confederazione Italiana della Piccola e Media Industria Privata, accoglie con favore l'iniziativa della Commissione europea di avviare una valutazione approfondita delle Direttive 2004/9/CE e 2004/10/CE in materia di Buone Pratiche di Laboratorio (BPL).

Directives 2004/9/EC and 2004/10/EC have improved the reliability and consistency of safety data across the EU by harmonizing Good Laboratory Practice standards and adopting the OECD Principles of Good Laboratory Practice. This has increased efficiency, reduced duplicate studies, and enabled mutual recognition of data between member states.

As a large multinational company, BASF operates several fully Good Laboratory Practice compliant Test Facilities in Europe with a focus on chemicals, crop protection including seeds and traits and toxicology. Size of the Test Facilities is up to several hundred employees, with some facilities operating in addition to GLP under other quality systems, eg. ISO norms.

EFPIA welcomes the opportunity to contribute to the Call for Evidence regarding the Good Laboratory Practice (GLP) framework. From our perspective, the current GLP directive and the existing framework are functioning well and continue to support high-quality non-clinical studies across the EU. EFPIA finds that the GLP principles as defined by the OECD are both relevant and value-adding.

Feedback from Miller International Knowledge (MIK) As an interdisciplinary organization focused on legal compliance, ethics, and responsible innovation in science and technology, Miller International Knowledge (MIK) welcomes the opportunity to provide input on the evaluation of Directives 2004/9/EC and 2004/10/EC on Good Laboratory Practice (GLP).

The evaluation of the Good Laboratory Practice (GLP) Directives is a timely and important initiative. In an era where chemical safety, environmental protection, and human health are under increasing scrutiny, ensuring the reliability and credibility of chemical testing data is critical.

As a pesticide regulatory affairs specialist, GLP is THE most important certification that I look for in a laboratory. Next is the country where the laboratory is located because all GLP-certifying National bodies are as unbiased, competent or thorough as they should be.