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Set Alert for Manufacturing

Despite Progress, More Work Needed To Harmonize FDA and EMA Criteria For Biowaivers

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.

Manufacturing Quality BioPharmaceutical Europe

Latest From Manufacturing

EMA Maps Global Drug Supply Chain Regulatory Gaps For ICMRA

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.

Distribution Manufacturing

FDA Enforcement And Compliance In Brief

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.

Manufacturing Manufacturing Quality

WHO Issues Best Practice Guide For Counterfeit Drug Detection

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.

Manufacturing Manufacturing Quality

ICH Sets Three-Year Goal To Harmonize Criteria For Biowaivers

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.

Manufacturing Manufacturing Quality

Does India's Perpetual Licensing Plan Risk Backfiring?

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.

Manufacturing India

FDA Outlines Criteria For Approving Manufacturing Supplements Under GDUFA

Generic drug manufacturers are told by FDA when and how it will accept prior approval supplements under GDUFA.

United States Manufacturing Quality
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