EMA launches new drug early access scheme

The European Medicines Agency (EMA) is set to follow UK regulators' lead after unveiling its own scheme to speed up access to new drugs.

Under this pilot initiative – unveiled just days after the announcement of the Early Access to Medicines Scheme in Britain – staggered approvals may be granted to certain treatments before late-stage trials have been conducted.

Pharmaceutical firms have been invited to submit ongoing development programmes for consideration under its "adaptive licensing pilot project".

Hans-Georg Eichler, senior medical officer at the EMA, said: "We intend to explore with real medicines in development a progressive licensing approach that would allow timely access for patients."

The agency noted the new initiative builds on existing regulatory processes, including those related to scientific advice, centralised use for compassionate reasons and the conditional marketing authorisation mechanism for treatments addressing life-threatening ailments.

During the pilot stage of this scheme, the European Commission will "examine the legal and policy aspects related to adaptive licensing in collaboration with the EU member states".