European Medicines Agency Details Fast Track Procedures for Development and Authorisation of Covid-19 Medicines and Vaccines
On 4 May 2020, the European Medicines Agency (EMA) presented the tools which it has started using in order to expedite the development and authorisation of Covid-19 related medicines and vaccines (see, attached press-release and outline of EMA’s rapid formal review procedures related to COVID-19). EMA wants to facilitate the rapid marketing of such products but insists, through its Executive Director Guido Rasi, that this “will only be possible if applications are supported by robust and sound scientific evidence that allows EMA to conclude on a positive benefit-risk balance for these products.”
EMA’s action plan rests on two pillars: (i) accelerated support during research and development; and (ii) faster evaluation in authorisation and post-authorisation procedures.
Research and development - At this stage, EMA will focus on giving rapid scientific advice and authorising speedily pediatric investigation plans.
Authorisation and post-authorisation - Here EMA will rely, as appropriate, on rolling reviews (which allow EMA to assess data as they become available) and accelerated assessments. These procedures will also be open to applications for extensions of indications for medicines that are already on the market and are being repurposed for treatment or prevention of Covid-19.
While not squarely falling within its remit, compassionate use programmes also benefit from EMA’s attention. They are set up and administered by the Member States, but EMA promises to give recommendations for a group of patients and thus contribute to an EU-wide approach.
The EMA had already occasion to put parts of its action plan in practice when starting a rolling review of remdesivir and, earlier, offering recommendations for compassionate use programmes involving remdesivir.