THE PHARMACEUTICAL PACKAGE Widely considered to be the largest overhaul in EU-level pharmaceutical legislation in the last two decades, this package consists of a number of legislative initiatives and non-binding initiatives. Please find an overview of each below as well as key conclusions. Legislative proposals: A Directive on the Union code relating to medicinal products [read more…]
Regulatory and Market Access Parallel Consultation (CHMP/EUnetHTA)
Pharma Design Ltd has been a supporter of integrated Regulatory and Market Access advice in EU since its foundation in 2009. The progress made since then on a parallel EMA and HTA assessment is therefore welcome, although we feel that a lot of work still needs to be done and many hurdles overcome especially on [read more…]
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 discussed at the highest political level. Tough questions were asked and manufacturers were forced to provide some real answers. So [read more…]
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 dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients [read more…]
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 from Member States in the European Union and European Economic Area, united in the Heads of Medicines Agencies (HMA), and [read more…]
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 data extrapolation and interpretation of toxicology findings for human use. The text of the concept paper is presented below: [read more…]