COVID-19 May Delay WHO’s Prequalification Of Drugs, Devices, IVDs
Work and movement-related restrictions are affecting the ability of companies to provide a timely response to questions relating to their prequalification dossiers.
You may also be interested in...
COVID-19 Prompts WHO To Waive Onsite Prequalification Inspections
Agency describes criteria for waiving routine prequalification inspections for existing drugs and vaccines as well as new products in light of COVID-19.
UK’s Revamped Clinical Trials Framework To Offer Faster Application Review Timelines Than EU
The UK has finalized plans for delivering what it believes will be a stable and streamlined clinical trials framework following its departure from the EU. Transparency, patient involvement and diversity are high on the agenda.
EU IVD Regulation Delaying Clinical Trials Using Diagnostics
The challenges posed by the implementation of the EU IVD Regulation are having a negative impact on medicine trials using diagnostics. Many such studies are currently stalled and research-based drug companies are calling on all partners to engage in dialog to find an urgent solution.