The non-clinical development category focuses on the non-clinical phase of therapy development, where new treatments are tested in laboratory and animal studies before they are deemed safe for human trials. This includes pharmacokinetics, toxicology, and pharmacodynamics studies to understand the behavior of new compounds in biological systems. The goal is to gather comprehensive data on safety, efficacy, and biological activity to support the progression to clinical trials. This category emphasizes the importance of rigorous scientific investigation and compliance with regulatory standards to ensure the safety and effectiveness of new therapies before they reach clinical development.
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BMRI is a European research infrastructure maximizing the use of biosamples, images and data for health research. They have various services such as an online one-stop-shop to request samples, images and data from multiple national health registries, health databases, image archives and biobanks. Request Portal | BBMRI
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EATRIS is a European research infrastructure on translational medicine. They have services on (early) HTA, collaboration, expert monitoring and translational feasibility assessment next to self-paced online courses.
Data requirements for non-clinical development are laid down in EU
legislation. The EMA provides a number of guidelines on Non-Clinical
and Clinical development. The main guidelines related to early clinical
development are the following.
- Non-Clinical Safety Studies For The Conduct Of Human Clinical Trials For Pharmaceuticals (ICH M3), CPMP/ICH/286/95.
- Preclinical safety evaluation of biotechnology-derived pharmaceuticals (ICH S6).
- Safety pharmacology studies for human pharmaceuticals (ICH S7A).
- Toxicokinetics: the assessment of systemic exposure in toxicity studies (ICH S3A).
In the case of medicinal products consisting of, or more likely containing,
a GMO, the requirement for conducting an Environmental Risk Assessment
(ERA) stems from provisions appearing in both pharmaceutical sector and
environmental sector legislation. For GMOs, a specific ERA is required.
A specific guideline on environmental risk assessments for medicinal
products containing, or consisting of, GMOs summarises the legal situation
and explains how the legislative requirements should be implemented by
regulators and complied with by developers for such products. (see this
Guideline).