medicinal product development

On 19 March 2014, the EMA announced the launch of its adaptive licensing pilot project along with an invitation to interested companies to submit their ongoing medicine development programmes to be considered as pilot cases.

The term “adaptive licensing” (also known as “staggered approval” or “progressive licensing”) describes a process which allows patients to have early access to new medicinal products by starting with an early authorisation of a product for a specific, restricted patient subset and gradually adapting the marketing authorisation to include broader patient populations as additional clinical evidence is gathered.

The adaptive licensing approach is expected to ensure timely access for patients to new medicines, especially those addressing serious conditions with unmet medical needs, while at the same time safeguarding the principle of risk-benefit assessment.
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