Articles
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Top 5 issues to look out for in the access to medicines debate in Europe
For pharmaceuticals in Europe, 2016 marked a turning point. For the first time, in a frank and comprehensive dialogue, all the problems and deficiencies of the current business model were finally brought centre stage and…
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Priority Medicines (PRIME)
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…
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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…
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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…