Early patient access to new medicines
The European Medicines Agency (EMA) makes use of EU procedures to get innovative medicines to the patients as early as possible.
The procedures are specifically meant for medicines that target an unmet medical need or are of major public health interest and are eligible for the centralised procedure.
EMA offers several options to support this early patient access to new medicines. One of them is the PRIME (priority medicines) scheme, a program on voluntary basis which offers support in an early stage of the product development and is aimed at making an early dialogue possible between different stakeholders such as EMA and the early developers.
Via PRIME, candidates can be identified in an early stage as being eligible for Accelerated Assessment, but the latter can also be applied for without participating in PRIME.
Accelerated Assessment is another option for early access and can reduce the timeframe of review from 210 days to 150 days or less.
The next option is Conditional Marketing Authorisation, where a MA is granted before complete clinical data are available. However, the MAH must fulfil specific obligations within defined timelines. Once those obligations have been fulfilled, a conditional MA can be converted into a standard MA.
On national level applicants can apply for Compassionate Use. Please also check out our earlier post on this subject.