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Global Industry Bodies Urge Wider Use Of COVID-19-Related Regulatory Flexibilities

Harmonized Inspection Practices Are One Way Forward

 
• By Ian Schofield

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.

Spotlight
COVID-related flexibilities are in the spotlight • Source: Alamy

A group of national and international bodies representing R&D-based and generic/biosimilar companies has proposed a range of regulatory flexibilities that it says should be applied more broadly by global regulators in order to expand manufacturing capacity for COVID-19 medicines and vaccines.

The flexibilities include more streamlined stability testing requirements and greater use of harmonized approaches to alternative inspection

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