ICH: India, Mexico And Russia Among New Observers; Benefit-Risk Guideline Adopted
This article was originally published in SRA
India, Mexico, Singapore, South Korea, Russia and Taiwan are among the latest countries to become observers at the International Council for Harmonisation, which has been seeking to establish itself as a 'truly global platform' since undergoing major structural reforms last year1.
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ICH outlines an ambitious work plan to harmonize the disparate requirements for biowaivers among regulators worldwide; New concept paper and business plan highlight areas of disagreement.
While FDA took a big leap forward by waiving bioequivalence studies for BCS Class 3 drugs and aligning biowaiver rules with the EU, there is still work that needs to be done to harmonize solubility and permeability criteria. Until these differences are resolved, pharmaceutical manufacturers may still need to perform separate studies in getting biowaivers approved in these to jurisdictions. This issue is taking on more prominence now as ICH is looking into harmonizing biowaiver requirements worldwide.
The International Council for Harmonisation's final guidance on standardizing benefit-risk information in drug submissions is expected to support regulatory decision-making through a more consistent description of information.