EU looks to speed drug access with staggered approval process

by Reuters
Wednesday, 19 March 2014 19:04 GMT

LONDON, March 19 (Reuters) - Europe's medicines regulator will try out a new process of staggered drug approvals in a bid to accelerate access to new medicines.

The decision to pilot so-called adaptive licensing reflects an urgency among health authorities to find ways of making promising drugs available earlier, instead of waiting years for them to work their way through the traditional approval process.

The European Medicines Agency said on Wednesday it was inviting companies to submit drug development programmes for inclusion in the pilot project.

Adaptive or progressive licensing has long been talked about as a concept but has yet to be adopted by regulators, who typically require firms to carry out three phases of extensive clinical trials before a medicine is licensed for use.

Under adaptive licensing, a drug would get early authorisation for use in a restricted patient population, followed by further evidence gathering and adaptations of approval to expand access to broader patient groups.

Hans-Georg Eichler, the agency's senior medical officer, said the programme would target medicines that addressed serious conditions with unmet medical needs.

"The approach seeks to maximize the positive impact of new medicines on public health by balancing timely access for patients with the need to provide adequate evolving information on their benefits and risks," he said in a statement.

The aim of pilot programme is to gather experience, address a range of technical and scientific questions and further refine how the adaptive licensing pathway should be designed for different product types.

European officials also plan to examine the legal and policy aspects related to adaptive licensing as the programme progresses.

The British government announced a separate early-access plan last week that will see some seriously ill patients get access to novel medicines months or even years before they are officially licensed for sale.

The United States, meanwhile, has a relatively new scheme designed to speed the development of "breakthrough" medicines. (Reporting by Ben Hirschler, editing by David Evans)

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