Published by the EMA 11/May/2021.

In the process of streamlining assessment for medicinal products during the COVID-19 pandemic, the EMA is implementing additional temporary measures in the European medicines regulatory network . This should allow assessors to concentrate on the ever-increasing volume of COVID-19-related applications, whether vaccines or treatments. The focus will be on vaccines and therapeutics and – of course – safety monitoring of vaccines already given.

To ensure high standards of scientific evaluations during this pandemic, when the EMA has to dedicate resources specifically to COVID-19, the EMA has agreed a number of measures with the Management Board as outlined below. These measures complement the arrangements prioritising COVID-19 procedures that are already in place.

Temporary measures, starting from May 2021 for initial marketing authorisations, include:

For pre-authorisation procedures (text from the EMA website)

• All initial marketing authorisation 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 human medicines committee (CHMP).
• 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.
• 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).

It is anticipated, that the responsibilities for rapporteur and co-rapporteur will not change though.

For post-authorisation procedures (text from the EMA website)

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:

• 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.
• 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.

These changes will also take effect from May 2021.

Additional activities will be implemented as needed, here specifically to facilitate the appointment of any rapporteur or co-rapporteur. The EMA will, in agreement with the CHMP and the Management Board, regularly review the measures if required and further support by the EMA might be available.

Published by Olaf Schoepke

Passionate about sharing ideas with regulatory professionals in the human and veterinary medicinal product space.

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