UK likes the look of EMA quicker approvals pilot

NICE

UK trade associations, politicians, payors and patients have met with the European Medicines Agency to discuss the pros and cons of the latter’s adaptive licensing scheme to speed up access to new treatments.

The Association of the British Pharmaceutical Industry, the BioIndustry Association and the Centre for the Advancement of Sustainable Medical Innovation have hosted what they refer to as a ‘one-stop-shop’ on adaptive licensing. The process would involve early approval of a drug iin a restricted patient population, followed by what the EMA has called ‘phases of evidence- gathering and adaptations of the marketing authorisation to expand access.

To date, 14 companies have submitted applications and the EMA will communicate shortly which of these will be taken forward.

For more details, go to: http://www.pharmatimes.com/Article/14-06-03/UK_likes_the_look_of_EMA_quicker_approvals_pilot.aspx#ixzz33b4LzWFU

Michael Wonder

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Michael Wonder

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