Marketing Authorisation Application [MAA]

Non-clinical studies can be performed at any time during the life-cycle of the product, testing the compound outside of humans. Non-clinical studies aim to identify candidate therapies with the greatest probability of success, assess safety, and build solid scientific foundations before the transition to clinical development phases.

Data from non-clinical trials is important as a predictor and decision-making tool in the medicines development process. Adequate and satisfactory non-clinical results are required before a medicine may be administered to healthy human volunteers, and non-clinical data is closely reviewed before a medicine is allowed to enter the market.

A rigorous non-clinical programme must be completed before a medicine may be tested in humans for the first time in Phase I clincial trials.

The regulations governing paediatric medicine differ between the EU and the US.

The European Pharmacopoeia comprises quality standards for active pharmaceutical substances, as well as analytical methods for the identification of the substance and the evaluation of its quality and quantitative strength.