Proper Venue Sought for Resolving Global Pharma Supply Chain Crisis
This article was originally published in The Gold Sheet
Executive Summary
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.
You may also be interested in...
ICH Reforms Will "Professionalize" Harmonization, PhRMA's Rep Says
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.
Brazil Blazing Trail on Excipient GMPs
Brazil’s ANVISA shows global leadership in regulating pharmaceutical excipients with proposed excipient GMPs. Comments were generally favorable, though there were concerns about the extent of applicability to foreign excipient makers.