Articles
-
The European Medicines Regulatory Framework
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…
-
Concept paper on the revision of ‘First-in-Human’ Guideline clinical trials
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…