PRIME is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients [read more…]

  The European regulatory system for medicines is a unique model in the global regulatory environment. The system is based on a network of all national medicines regulatory authorities for both human and veterinary medicines from Member States in the European Union and European Economic Area, united in the Heads of Medicines Agencies (HMA), and [read more…]

EMA has just released a concept paper to revise the First-in-Human Guideline and is requesting comments to address the need for updated and more streamlined contents, particularly in the area of PK/PD data integration, animal data extrapolation and interpretation of toxicology findings for human use. The text of the concept paper is presented below:   [read more…]