Pandemic Prompts EU Drugs Watchdog to Simplify Non-COVID Processes

By Josephine Mason

May 12, 2021

LONDON (Reuters) - Europe's medicines watchdog said it will simplify some of its review procedures to focus on COVID-19 treatments and vaccines as it faces a pandemic-driven surge in new drug applications.

The Amsterdam-based European Medicines Agency (EMA) said on Tuesday the changes would come into effect this month and were due to the "very active pipeline" of upcoming COVID-19 vaccines and treatments and the roll-out of vaccines across the region.

The agency, which approves drugs for use in the 27-member European Union bloc, has already made other changes to its procedures as the pharmaceuticals industry rushes to test and launch vaccines and drugs to treat and prevent the coronavirus, which has killed more than 3 million people worldwide.

Earlier this year, the EMA said it would fast-track assessments of any COVID-19 vaccines that are modified to protect against variants of the virus.

Under the new procedures, for all applications there will temporarily no longer be a separate, formally appointed peer reviewer, but the assessment will rely on an intrinsic peer review that is part of the evaluation process handled by the EMA's Committee for Medicinal Products for Human Use (CHMP).

In the case of COVID-19 products, there are additional reviews by the COVID-19 EMA pandemic Task Force (COVID-ETF), it said in a statement, adding that all initial marketing authorisation applications (MAAs) for COVID-19 vaccines and therapeutics will 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 the CHMP, it said.

For initial MAAs for non-COVID-19 products though, unless they are advanced therapy medicinal products or other very complex medicines to be considered by the CHMP, the co-rapporteur will no longer provide a separate assessment report 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.

While the measures will affect the way the initial MAA reports are prepared, the responsibilities of the rapporteur and co-rapporteur will not change, it said.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....