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Global Harmonization Task Force Meeting In Brief

This article was originally published in The Gray Sheet

Executive Summary

Asian Harmonization: Members of the Asian Harmonization Working Party, whose 16 economies include China, Indonesia and Korea and will soon include India, have agreed that if a product is approved after submission of one common government dossier, it will receive approval in other member countries, said Mukundan Sugundan Pillay, AHWP chair and deputy director general of health, research and technical support in the Malaysian Ministry of Health, Oct. 3 at the Global Harmonization Task Force conference in Washington, D.C. "We are also working on the principle of not reinventing the wheel, because if FDA has spent so much money evaluating a device, I'm not going to look at it - I'll approve it in 24 hours," he added
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