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EMA introduces new measures to enable flexibility for non-COVID-19 procedures

Regulator will streamline processes to allow its experts to focus on COVID-19-related assessments

The European Medicines Agency (EMA) has introduced additional measures aimed at streamlining its activities to allow its experts to focus on COVID-19-related assessment processes.

The regulator has announced that it will be implementing new temporary measures as a direct result of a ‘very active pipeline of upcoming COVID-19 vaccines and treatments’, as well as a number of ongoing procedures and the EU’s vaccine rollout.

This has caused the EMA’s resources to become ‘highly focused’ on reviewing COVID-19 vaccines and therapeutics, while also ensuring these medicines have met ‘rigorous safety’ standards.

The temporary measures are to enable ‘maximum flexibility’ with timetables or temporary changes of rapporteurs –  members of a committee who lead the evaluation of an application – for non-COVID-19 processes.

Among these measures are new procedures enabling all initial marketing authorisation applications (MAA) for COVID-19 vaccines and therapeutics to be given first priority.

In addition, for initial MAAs for non-COVD-19 products, excluding advanced therapy medicinal products or very complex medicines, the co-rapporteur will not be required to provide a separate assessment to the rapporteur in the first evaluation phase.

For all applications the EMA will also temporarily remove the need for a separate, formally appointed peer reviewer. The assessments will instead rely on the intrinsic peer review as part of the Committee for Medicinal Products for Human Use’s (CHMP) role in the evaluation process.

For post-authorisation procedures, the EMA has amended the co-rapporteurs’ involvement in the assessment process.

Although the co-rapporteur will still be systematically involved in all post-authorisation procedures, the EMA has said that the need for two separate assessment reports will depend on the ‘complexity of the application’ for COVID-19 products.

For non-COVID-19 products, the co-rapporteur will produce comments on the rapporteur’s assessment but will not need to draft a full separate report in the first phase of evaluation.

All the new measures are set to take effect from May 2021, the EMA said in a statement.

“[The] EMA will regularly review these measures and amend them as necessary, in agreement with the CHMP and the management board,” the regulator added.

Article by
Lucy Parsons

13th May 2021

From: Regulatory



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