International – ICMRA: Industry’s commitment to quality can facilitate regulatory flexibility

Frequent communication with industry and relying on assessments by other regulators have enabled the rapid scale-up of COVID-19 vaccines and therapeutics, asserted regulators and industry representatives attending a July workshop sponsored by the International Coalition of Medicines Regulatory Authorities (ICMRA).

The workshop explored how different regulatory tools are being deployed to increase manufacturing capacity for vaccines during the COVID-19 pandemic. The workshop had dual goals of helping regulators understand the manufacturing challenges faced by industry during the pandemic, while at the same time boosting industry’s awareness of the variety of regulatory pathways and flexibilities that allowed vaccine and therapeutics manufacturing to scale so rapidly.

The virtual workshop included representatives from over 30 medicines regulatory authorities globally, and 330 participants listened online. The transcript of the workshop was recently made available…