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PIC/S agrees to share with WHO, adds members, mulls FDA application

This article was originally published in The Gold Sheet

Executive Summary

The Pharmaceutical Inspection Cooperation Scheme May 27 reached agreement with the World Health Organization's team for quality assurance and safety and its team for biologicals and medicines on an agreement to cooperate in the areas of training inspectors and sharing documents. The international group of pharmaceutical inspection agencies has grown from its core in Europe to include agencies from 37 countries around the world including Lithuania, which joined this month. Iran has asked to join, and there are signs of interest from Japan, Brazil, Russia and New Zealand. According to the minutes, there was talk at its latest meeting in early May of establishing a second-tier category for inspection authorities in countries such as India and China that are not yet competent enough for full membership. Meanwhile, FDA's application to join is still pending, with an audit of the agency expected later this year

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