The European Medicines Agency (EMA) has recently implemented new measures to minimise animal testing during medicines development. The Agency’s main responsibilities are to protect and promote human and animal health by evaluating and monitoring medicines in the EU. Their Innovation Task Force is now supporting alternative approaches to animal models, very much in-line with InPharma project, which is working towards making drug development more predictable and reducing animal testing in drug development by using a fully integrated, animal-free, end-to-end modelling approach to the formulation of drugs for oral administration.
The Innovation Task Force offers a platform for early collaborations between regulators and drug developers to discuss innovative aspects such as emerging therapies, methods and technologies and will support the development and implementation of New Approach Methodologies following the 3Rs principles — replace, reduce and refine.
As innovative developments arise from both work packages within the InPharma project, exciting opportunities exist for an early dialogue with the Innovation Task Force via briefing meetings. Their objective would be to facilitate informal exchange of information and guidance in the development process, covering regulatory, technical and scientific issues. Brainstorming discussions would be led by experts from the regulatory network, working parties and committees to ensure the best available scientific expertise is represented.