Friday 21 March 2014

EUROPEAN MEDICINES AGENCY LAUNCHES ADAPTIVE LICENSING PILOT PROJECT

The adaptive licensing approach launched this week by the European Medicines Agency (EMA), aims to improve timely access for patients to new medicines.

This newly implemented process starts with the early authorisation of a medicine in a restricted patient population, followed by iterative phases of evidence gathering and adaptations of the marketing authorisation to expand access to the medicine to broader patient populations.

Building on their existing mechanisms, centralised compassionate use and conditional marketing authorisation; the EMA intends to include as many programmes as necessary in this pilot phase in order to gather sufficient knowledge and experience. Companies are invited to submit proposals for experimental medicines in the early stage of clinical development.

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