EMA Rolls Out New Procedures for Assessing COVID & Non-COVID ProductsBy
The European Medicines Agency (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.
The EMA has agreed to the news measures, with its management board, to ensure that the network can continue to dedicate resources to COVID-19 while maintaining its scientific evaluations. These measures complement arrangements prioritizing COVID-19 procedures that are already in place under the current Phase II 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 pre-authorization procedures, which will apply to initial marketing authorization applications starting in May 2021, and post-authorization procedures, which will take effect from May 2021. These measures are outlined below.
COVID-19 products. All initial marketing authorization applications (MAAs) for COVID-19 vaccines and therapeutics will continue to be given first priority. There will continue to be two independent, simultaneous scientific assessments with separate initial reports for these procedures, with no change to the current responsibilities of the rapporteur and co-rapporteur at EMA’s Committee for Medicinal Products for Human Use (CHMP).
Non-COVID-19 products. For initial MAAs for non-COVID-19 products, unless they are advanced therapy medicinal products (ATMPs) or other very complex medicines to be considered by the CHMP, the co-rapporteur will no longer provide a separate assessment report to the rapporteur in the first phase of the evaluation. Instead, he or she will review the submitted data and give a detailed critique of the rapporteur’s assessment report. These measures will free up some of the co-rapporteur resources to focus on COVID-19 activities.
All applications. For all applications, there will temporarily no longer be a separate, formally appointed peer reviewer, but the assessment will rely on the intrinsic peer review that is part of the CHMP’s role in the evaluation process. In the case of COVID-19 products, there are additional reviews by the COVID-19 EMA Pandemic Task Force (COVID-ETF).
Currently, the involvement of co-rapporteurs in the assessment of post-authorization 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 outlined below.
COVID-19 products. For COVID-19 products, the co-rapporteur will be systematically involved in all such procedures; however, the need for two separate assessment reports, or for providing a detailed critique of the rapporteur’s assessment report, will depend on the complexity of the application.
Non-COVID-19 products. For non-COVID‑19 products, when the co-rapporteur is involved, the co-rapporteur will produce comments on the rapporteur’s assessment report but will not draft a full separate report in the first phase of the evaluation.
The 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, the EMA will also expand the support from the EMA Secretariat in the assessment process.
The agency says it will regularly review these measures and amend them as necessary, in agreement with the EMA’s Committee for Medicinal Products for Human Use and its management board.
Source: European Medicines Agency