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EMA looks at flexible drug licensing

Regulator looks to pilot programme to stagger approvals of new medicines


The European Medicines Agency (EMA) has made good on its promise to look at adaptive licensing - staggered approval of new therapies to balance access with safety evidence - with the launch of a new pilot.

The EMA is looking for volunteer companies to take part in the real-world pilot, which will involve drugs already in early-stage clinical development, and has published a framework document (docx) to give guidance on the proposed process.

Adaptive licensing means that drug candidates that meet an unmet medical need can be approved for use in a restricted patient group, with their use gradually expanded as additional safety and efficacy data is generated.

The pilot will involve pharma companies, the EMA and health technology assessment (HTA) bodies, as well as "organisations issuing clinical treatment guidelines and patient organisations," said the EMA in a statement.

The agency has been talking about adaptive licensing for some time - it as featured in the Road Map to 2015 document adopted in 2010 - and reiterated the need for changes to its licensing framework in the wake of the approval last year of UniQure's gene therapy Glybera (alipogene tiparvovec) for lipoprotein lipase deficiency.

Glybera was eventually approved for a narrower group of patients than originally sought but could have been made available sooner if an adaptive licensing framework was available, said the EMA. It had been due to start a pilot in 2012 but the programme was delayed by other agency priorities.

"We intend to explore with real medicines in development a progressive licensing approach that would allow timely access for patients to new medicines that address serious conditions with unmet medical needs," said Hans-Georg Eichler, the EMA's senior medical officer.

The challenge will be to make sure the adaptive licensing approach is not used as a means of rescuing drug programmes that are starting to fail, or becomes perceived as a lowering of regulatory standards.

Industry has voiced its support for the pilot, with the BioIndustry Association in the UK saying it would encourage its members to join the pilot having "campaigned for the introduction of adaptive licensing for a number of years”.

Meanwhile, other regulators around the world are also exploring the adaptive licensing model. Singapore's Health Sciences Authority (HSA) launched an initiative called New Drug Development Paradigms (NEWDIGS) last year in collaboration with the Massachusetts Institute of Technology (MIT) in the US, while Health Canada has also been developing the concept under the banner of 'progressive licensing'.

20th March 2014

From: Sales, Regulatory



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