ICH Expansion Prompts WHO To Review Definition Of 'Stringent Regulatory Authorities'
European research-based pharmaceutical industry association, EFPIA, says it "makes sense" for the World Health Organization to review the concept of "stringent regulatory authorities," which is linked to a country's membership of the International Council for Harmonisation.
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The new framework, when finalized, will replace the widely-recognized concept of "stringent regulatory authorities."
The WHO is planning to introduce a new version of its tool for evaluating the “maturity level” of national drug regulatory agencies across the world as part of a drive to strengthen regulatory systems and make them more effective and transparent. It is also introducing the concept of "WHO-listed authority".
Despite putting it on hold last year, the World Health Organization is keeping its idea of biosimilar naming guidance alive. And at a recent conference it updated delegates on the pilot project for prequalifying biosimilar versions of infliximab and trastuzumab.