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EMA adaptive licensing project gathers pace

Regulator picks two drugs to pilot early access scheme
European Medicines Agency (EMA)

A European Medicine Agency (EMA) pilot project looking at developing a progressive licensing model for new medicines is coming to fruition, with the first two drugs selected to road-test the scheme.

The EMA has been talking about developing an adaptive licensing framework for some time and called for volunteer companies to take part in the pilot earlier this year.

Adaptive licensing means that some drug candidates that offer an important therapeutic advance can be approved for use in a restricted patient group, with wider use coming later as additional safety and efficacy data is generated.

"The approach seeks to maximise 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," according to the agency.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has also been looking at adaptive licensing models and after a information gathering and sharing exercise has started preparations for its own pilot project.

The EMA received 20 applications from companies wanting to put early-stage drug candidates into the project, and says it has selected two from the first block of nine candidates, with another four being held in reserve. Three applications were rejected, and the remaining 11 are still under consideration.

"We are very pleased to have received this number of applications in a short period of time," said Hans-Georg Eichler, the EMA's senior medical officer. "The projects submitted came from very early responders, and we know that more proposals are on their way."

The agency said it will now contact the sponsors of the selected applications to explore how adaptive licensing can be developed for these specific medicines, with input from multiple stakeholders including health technology assessment (HTA) bodies and patient organisations.

Earlier this month, UK Parliamentary Under Secretary of State for Quality Earl Howe told a workshop on adaptive licensing that if the approach is successful it will demonstrate that regulation is "not a noose which stifles but rather a safety mechanism which can release medicines to patients in need."

The workshop - convened by the Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA) and the Centre for the Advancement of Sustainable Medical Innovation (CASMI) - discussed a number of issues related to adaptive licensing, including the capacity of regulators to tackle the extra workload.

Another concern was how adaptive licensing pricing will fit in a global product development strategy, and whether it is realistic for all European payors to accept greater uncertainty.

Article by
Phil Taylor

9th June 2014

From: Regulatory



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