ICH Reforms Will "Professionalize" Harmonization, PhRMA's Rep Says
This article was originally published in The Pink Sheet Daily
Shift in balance of power to regulators is "appropriate" and it's important that the public has trust in ICH, PhRMA Associate VP for Scientific and Regulatory Affairs Patrick Brady says; FDA proposes to contribute $500,000 per year to revised group.
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The scandal surrounding the withdrawal of Servier’s diabetes drug Mediator (benfluorex) continues to rock the French medical establishment, but it also has drawn attention to the issue of regulators' transparency more broadly – including at the European Medicines Agency.
Who can coordinate a global response to the pharma supply chain crisis? Industry and regulators debate whether ICH, which smoothed over GMP differences among developed nations, is the right institution for today’s problems, which emanate from non-ICH countries. FDA’s Woodcock describes what the goal should be. IPEC proposes forum to help launch global excipient GMPs. Time is short, with excipient GMPs proliferating in China, Brazil, elsewhere. Support grows for approaching ICH to establish a Q7B guideline for excipients comparable to the Q7A guideline for active ingredients. Big impact expected from Rep. John Dingell’s FDA Globalization Act based on latest discussion draft. Second round of GMP revisions may call for supplier audits, FDA says. IPEC completes excipient qualification guidelines, which set forth process for negotiating quality agreements. The EU advances anti-counterfeiting, regulatory cooperation efforts. Third-party supplier auditing poised for growth.
Marinus’s ganaxolone has lost its accelerated assessment status mid-review at the European Medicines Agency while Roche’s glofitamab will be fast-tracked once a filing has been made.