Global Industry Bodies Urge Wider Use Of COVID-19-Related Regulatory Flexibilities
Harmonized Inspection Practices Are One Way Forward
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.
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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.
Equitable access to pandemic medicines and vaccines will be at the core of the WHO’s future global pandemic treaty. Exactly what this will mean for the pharmaceutical industry remains to be seen, but it is likely that companies wanting access to virus samples and other materials will need to agree to benefit sharing in the form of IP and technology transfer.
COVID-19, resource constraints and a forthcoming expansion of its responsibilities are piling the pressure on the EU regulator.