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