Europe -
Application of EU Clinical Trial Regulation Delayed to 2019

The European Medicines Agency’s management board said that due to technical difficulties with the development of IT systems, the application of the clinical trial regulation has to be postponed.

"Due to these delays, the EU Clinical Trial Regulation will now come into application in 2019 instead of October 2018, as previously scheduled," EMA said Friday.

The agency says it will provide an update at the next meeting of the Management Board in October 2017, following closer work with its IT service provider to ensure corrective measures are implemented...

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Europe -
Concept paper on revision of the guideline on clinical development of vaccines

The Guideline on clinical evaluation of vaccines (EMEA/CHMP/VWP/164653/2005) was developed during 2005-2006 and came into operation in 2007. It covers the design of clinical development programmes for new vaccines that are intended to provide pre- and post-exposure prophylaxis against infectious diseases. Some of the guidance provided is also relevant to the further development of licensed vaccines (i.e. generation of clinical data to support changes to the prescribing information in the post-authorisation period). Much of what this guideline says is still fully relevant to current vaccine...

France -
La France est en train de rater le virage des biomédicaments

Les investissements dans les biomédicaments ont chuté de 20% en 5 ans en France. Ces médicaments, issus du vivant, apparaissent pourtant comme l’avenir du secteur. D’ici 2020, ils devraient représenter 30% des ventes. 20 % de baisse en 5 ans. Les investissements dans la production de médicaments biologiques (issus de cellules ou d’organismes vivants) sont passés de 6 millions d’euros annuels par site à 4,8 millions d’euros. Selon une étude publiée le 21 juin par KPMG pour le syndicat des entreprises du médicament (LEEM) et Polepharma, seuls cinq médicaments biologiques ont été produits par la...

Europe -
Decision on EMA Relocation Set for November, Council Agrees on Bidding Procedure

At the EU Summit in Brussels on Thursday, the European Council backed a procedure to determine where the European Medicines Agency (EMA) will be relocated to following the UK's withdrawal from the EU. And, while previous reports had indicated the decision on where EMA will end up would be made by October 2017, the procedure adopted by the Council instead calls for a vote by the 27 EU member states, minus the UK (EU27), in November to give more time for member states to discuss the moves...

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