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The European Medicines Agency (EMA) has launched an adaptive licensing pilot project designed to improve access to new medicines, and is inviting companies to submit ongoing medicine development programs for consideration as prospective pilot cases.
Adaptive licensing builds on existing regulatory processes and intends to extend the use of elements that are already in place, including scientific advice, centralized compassionate use, the conditional marketing authorization mechanism (for medicines addressing life-threatening conditions), patients’ registries and pharmacovigilance tools that allow collection of real-life data and development of risk management plans, the EMA stated.
Read the full release here.