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The evolution of European Medicines Agency drug approval: the adaptive licensing

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In March 2014, the European Medicines Agency (EMA) launched a pilot project of ‘adaptive licensing’ to speed up access to drugs in development, in order to respond to unmet medical needs. The project will involve parallel scientific advice from the regulatory agency, pharmaceutical industry, the companies Health Technology Assessment (HTAs) bodies, organisations studying guidelines on clinical treatment and patient associations.

The traditional process of drug authorisation is divided into several parts, involving in vitro studies and in vivo studies in animals (preclinical studies), as well as phase 1–3 randomised controlled trials conducted in humans over a predefined period. When authorisation is granted, the drug is intended for a larger population. Some patients, depending on the type of drug, may be entered into register studies and/or followed by other forms of pharmacovigilance studies.1 ,2

According to the adaptive licensing process, however, initial drug authorisation may be granted on the basis of clinical studies involving a limited number of patients and thus is faster than the normal process. After the initial granting of the license, the number of patients treated slowly increases. The latter are enrolled in various forms of observational studies so as to generate information on the effectiveness and adverse effects of the drug in the real …

Correspondence to C Di Giorgio, Department of Clinical Pharmacy, Mediterranean Institute for Transplantation and Advanced Specialised Therapies (ISMETT), Palermo 90127, Italy; digiorgio82{at}

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