Non-clinical regulatory advice - including GLP

CTCG has published a new recommendation paper on principles of Good Laboratory Practices (GLP) for pivotal nonclinical studies and the documentation necessary for clinical trial applications in the EU. The aim is to provide transparency on the requirements and to clarify the expected level of information on the GLP status to include in the Clinical Trial Application in support of this.

The new recommendation paper is accessible via this link: GLP-recommendation-paper.pdf (hma.eu)

A template matrix recommended to use for clarity and easy overview during assessment is accessible via this link: GLP-recommendation-paper.pdf (hma.eu)

The 3R principles are a crucial part of the ethical and scientific foundation for the use of experimental animals. These principles encompass:

• Replacement: Substitution of animal testing with non-animal methods wherever possible.
• Reduction: Minimizing the number of animals used, ensuring that only the necessary number is employed to achieve scientifically valid results.
• Refinement: Enhancing the experiments to minimize animal stress and optimize their welfare.

We strive to integrate the 3R principles into the planning of clinical trials as early as possible through dialogue, guidance, and during our evaluation of clinical trial applications.

Implementing the 3R principles in practice is complex. Therefore, we aim to contribute to solutions with an open and pragmatic approach, focusing on both patient safety and animal welfare.

It is crucial to research and validate alternatives to animal testing. This knowledge is essential to ensure that the 3R principles can be implemented and lead to real changes in drug development.

The results of 3R research are processed at the EU level, particularly within the framework of the EU 3Rs Working Party (3RsWP), where we are strongly represented with two members.

The 3RsWP plays a central role in developing guidelines and recommendations, ensuring knowledge sharing and providing education, as well as supporting innovation and guidance through collaboration with entities such as the Innovation Task Force (ITF) and the Scientific Advice Working Party (SAWP), both of which are part of the European Medicines Agency (EMA).

Are you applying for a clinical trial with therapeutic vaccines?

Please be aware that a full safety and toxicological assessment of the immune response against an endogenous epitope is required. The ICH S6 guideline can be applied.

If an adjuvant is included, the WHO's “Guidelines on the non-clinical evaluation of vaccine adjuvants and adjuvanted vaccines, Annex 2, TRS No 987” can be used, but only for the adjuvant component.