06 May 2020 - Authored by:Rafi Allos
The European Medicines Agency (EMA) announced on 4 May that the EMA will accelerate regulatory procedures for supporting R&D of, and evaluating marketing authorisation applications (MAAs) for, medicines and vaccines for Covid-19 coronavirus. Further details regarding these measures are in an inventory published with the announcement. These measures are available both for new medicines and vaccines for Covid-19 and existing medicines that could be repurposed for Covid-19 use. These accelerated regulatory tools and pathways form part of the welcome measures the EMA is applying to support the expedited development and approval of treatments and vaccines to address the Covid-19 pandemic in the EU.
Support during Research and Development
- Rapid scientific advice – Fees for scientific advice on study design for Covid-19 products have been waived and the procedure has been reduced to a 20 day maximum (down from 40-70 days). There are no pre-specified submission dossier deadlines and the type and extent of the dossier will be determined on a case-by-case basis.
- Paediatric investigation plans (PIP) and compliance check – PIP review time for Covid-19 products has been reduced to 20 days (down from 120 days active review time). The compliance check in advance of an MAA has been reduced to 4 days.
Accelerated MAA Evaluation
The EMA will treat MAAs for Covid-19 products in an expedited manner using the following pathways:
- Rolling reviews – The EMA will accept rolling submissions of data as they become available which will remove the need to have all data available prior to any evaluation by the EMA. The EMA will assess this data as it becomes available over multiple review cycles (each cycle lasting around 2 weeks). Once the data package is complete, a formal MAA is submitted which can then be processed under a shortened timetable.
The EMA has already announced that it is reviewing data on Gilead’s remdesivir for Covid-19 on a rolling basis. Rolling reviews have also previously been available in emergency authorisation procedures for pandemic influenza vaccines and for Ebola vaccines.
An example of a completed rolling review assessment is that of Arepanrix (a vaccine for the 2009 H1H1 pandemic influenza developed by GlaxoSmithKline Biologicals). The EMA issued a positive opinion recommending the grant of a conditional MA on 20 January 2010, 6 months after the first rolling review data submission on 17 July 2009.
- Accelerated assessment – This procedure is available as an alternative to a rolling review. This requires a complete MA application but the maximum timeframe for review is shortened from 210 days to 150 days and the EMA has stated that in practice it will reduce the timeline to the absolute minimum where there is an urgent public health need.
- Further flexibility – The EMA has also stated that it is open to shortening any other procedural step that could have an important public health impact in dealing with the Covid-19 pandemic.
This article was co-authored by Thomas Kwoh.