EMA Streamlines Reviews of COVID-19 Products
The European Medicines Agency (EMA) is introducing new measures to streamline assessments and approvals of COVID-19 vaccines and treatments.
New marketing authorization applications for COVID-19 vaccines and therapeutics will continue to be given priority, the agency said, with two independent, simultaneous scientific assessments by the EMA’s human medicines committee (CHMP).
For all new applications there will “temporarily no longer be a separate, formally appointed peer- reviewer,” in addition to the peer review that the CHMP conducts during its evaluation. But for COVID-19 products, additional reviews will continue to be conducted by the EMA’s pandemic task force.
For new indications of COVID-19 products, the need for two separate assessment reports will depend on the complexity of the application, the agency said.