EMA is implementing additional temporary measures to further streamline activities in the European medicines regulatory network to enable experts to deal with an increasing volume of COVID-19-related assessment procedures.
Due to the very active pipeline of upcoming COVID-19 vaccines and treatments, a number of ongoing procedures, and the roll-out of authorised vaccines to millions of people across the EU, the resources of EMA and the European medicines regulatory network are highly focused on the review of COVID-19 vaccines and therapeutics, and the rigorous safety monitoring of these medicines.
EMA has agreed a number of measures with its Management Board to ensure that the network can continue to dedicate resources to COVID-19 whilst always maintaining the robustness of its scientific evaluations. These measures complement the arrangements prioritising COVID-19 procedures that are already in place under the current phase 2 of the business continuity plan for the European medicines regulatory network, such as maximum flexibility with timetables or temporary changes of rapporteurs for non-COVID-19 procedures. The new temporary measures include:
These measures will apply to initial MAAs starting in May 2021.
While the measures will affect the way the initial MAA reports are prepared, the responsibilities of the rapporteur and co-rapporteur will not change. Their role is to apply their scientific expertise throughout the MAA procedure, supported by their respective experts. In addition to drafting their first reports, they finalise the lists of questions, review the product information, assess the applicant’s responses, finalise the list of outstanding issues and lead on all committee discussions including oral explanations.
Currently, the involvement of co-rapporteurs in the assessment of post-authorisation procedures to extend indications and extension applications (so-called line extensions) depends on the complexity of the file. The approach to these procedures is being temporarily amended as follows:
These changes will take effect from May 2021.
EMA will also undertake additional activities, as needed, to facilitate the appointment or re-appointment of (co-)rapporteurs, such as even further facilitating the use of multinational assessment teams and the identification of experts that can support the assessment procedures. Where required, EMA will also expand the support from the EMA secretariat in the assessment process.
EMA will regularly review these measures and amend them as necessary, in agreement with the CHMP and the Management Board.