How to license a medicine for sale in the UK, including national and international routes, and information on fees. ”There are several routes to obtain a marketing authorisation in the United Kingdom (UK), Great Britain (England, Scotland and Wales) or Northern Ireland. The options available will be determined by the intended market and the [read more…]
New EMA Guideline on clinical investigation in the treatment of depression
EMA has published the 3rd revision of the Guideline on clinical investigation of medicinal products in the treatment of depression. This document updates and replaces the previous guideline (EMA/CHMP/185423/2010 Rev. 2). The main focus is on major depressive episodes that occur in the context of MDD. Bipolar and related disorders are separated from depressive [read more…]
Financial advantages of SME status
The European Medicines Agency (EMA) offers full or partial fee exemptions for its pre- and post-authorisation regulatory procedures for micro, small and medium-sized enterprises (SMEs) who want to develop and market medicines in the European Union (EU) and the European Economic Area (EEA). Procedure Fee incentives Scientific advice 90% fee reduction for non-orphan products [read more…]
New EU pharmaceutical package legislation
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…]