Australian Regulator Warns Of Delays To GMP Clearance Processes
Drug sponsors have been told to continue applying for extensions to good manufacturing practice clearances for overseas manufacturing sites as long as they meet the criteria for extension and apply in good time.
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The two countries want the European Commission’s proposals to be more closely examined for their possible negative effect on pharmaceutical investment decisions. The industry federation EFPIA says it is surprised more EU member states aren’t taking the same stance.
EU ministers say that implementing an appropriate fee structure that is more in line with actual costs will promote innovation in the pharmaceutical sector while ensuring “fair access” to safe and effective medicines for patients.
The World Health Organization has published a “step-by-step guide” for countries wishing to increase their capacity for monitoring pathogens with pandemic and epidemic potential. The EU and the UK have cleared an updated version of Moderna’s COVID-19 vaccine Spikevax targeting the XBB.1.5 variant, while the EU has followed the US in approving Gilead’s Veklury as the first treatment for COVID-19 patients with mild-to-severe liver damage.