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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.
Latest From Manufacturing
Gaps and overlaps in global and regional efforts to protect pharmaceutical supplies from intrusion of fake drugs, manufacturing quality problems and natural disasters are among the issues the European Medicines Agency has identified by mapping international initiatives for the International Coalition of Medicines Regulatory Authorities.
FDA traces B. cepacia to PharmaTech, Nippon Workers blocked FDA investigator, Yangzhou Hengyuan used wrong API, FDA bans two Chinese firms, and Kaley to provide FDA data integrity training.
WHO heeds the call of member states and issues guide on standard operating procedures for labs to follow in testing suspected counterfeit drug products. A majority of survey respondents had told WHO that drug counterfeiting is a major problem within their territories and that such a guidance is needed.
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.
India's wide-ranging drug regulation overhaul plan, including a perpetual licensing system aimed at simplifying processes and potentially delinking licensing and enforcement responsibilities may well emerge as a double-edged sword.
Generic drug manufacturers are told by FDA when and how it will accept prior approval supplements under GDUFA.
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