Regulatory Reliance Behind The Success Of African COVID-19 Vaccine Approvals
Regulatory reliance and work-sharing are becoming increasingly popular as a way of avoiding duplication and speeding up drug and vaccine assessments, but while there are many benefits, regulators should also be aware of some potential pitfalls, delegates at the TOPRA annual symposium heard this week.
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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.
A new draft document by the World Health Organization explains how regulatory authorities can leverage the work done by others to gain efficiencies and avoid duplication.
As talks restart this week on a future pandemic accord, the international drug industry body, the IFPMA, has reiterated its concerns over the negotiating text, saying some measures could “severely hinder responses to future pandemics.”