FDA, EMA and TGA aim to strengthen ties with developing nations’ regulators
This article was originally published in The Gold Sheet
Executive Summary
Officials with FDA, the European Medicines Agency and Australia's Therapeutic Goods Administration agreed in Washington last December on steps for improving overall GMP compliance in manufacturing of active pharmaceutical ingredients, EMA said April 12. Given that many APIs are made in countries that are still developing their domestic regulatory requirements, the three agencies agreed to encourage domestic regulatory authorities to become more involved in their overseas inspections. They also agreed on providing updated training on the International Conference on Harmonization's Q7 GMPs for APIs. The three agencies have found that they approach Q7 in slightly different ways that warrant further discussion. In late 2008, they launched a pilot to jointly inspect API facilities (1"The Gold Sheet," January 2009)