Non-clinical development

The European Medicines Agency's scientific guidelines on non-clinical development help medicine developers prepare marketing authorisation applications for human medicines.

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

Guidelines

• Reflection paper on lessons learned from the COVID-19 pandemic: Scientific considerations on non-clinical aspects
• Overview of the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs
• Regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches
• Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs
• ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals
• ICH S9 Non-clinical evaluation for anticancer pharmaceuticals
• ICH M3 (R2) Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals
• Strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products
• Non-clinical studies required before first clinical use of gene therapy medicinal products
• Evaluation of control samples for non-clinical safety studies: checking for contamination with the test substance
• Setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
• Non-clinical development of fixed combinations of medicinal products
• Non-clinical documentation for mixed marketing authorisation applications
• Non-clinical requirements for radiopharmaceuticals
• Investigation of chiral active substances
• Preclinical pharmacological and toxicological testing of vaccines
• Dossier structure and content for pandemic-influenza-vaccine marketing-authorisation application