EU Joint Regulatory Assessment Project Bears Fruit In COVID-19
Four more agencies are seeking to join ICMRA
The European Medicines Agency has reported progress with a collaborative project that involves other regulators in its assessments of COVID-19 products, and with the EU Medicines for All initiative for evaluating products for non-EU markets.
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The international COVID-19 collaborative assessment pilot, OPEN, helped regulators to reach broadly similar conclusions on vaccines and therapeutics and to avoid differences in labeling. However, most experts involved agreed there was room for improvement in some areas, particularly gaps between submissions to the different regulators.
A range of steps have been taken to allow the scale-up of manufacturing of COVID-19 products during the pandemic. Now industry says the use of these flexibilities needs to be expanded to enhance the current pandemic response and rapidly increase product supply.
Regulatory reliance and work-sharing are becoming increasingly popular as a way of avoiding duplication and speeding up drug and vaccine assessments, but while there are many benefits, regulators should also be aware of some potential pitfalls, delegates at the TOPRA annual symposium heard this week.