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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)

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Regulators start information-sharing agreement on API inspections

Regulators of the FDA, EMEA and Australia's TGA have announced the start of a pilot project aimed at collaborating on international inspections of active pharmaceutical ingredient manufacturers. The project, which was first outlined in July last year, aims to see "whether greater international collaboration and information sharing can help to better distribute inspection capacity, allowing more sites to be monitored and reducing unnecessary duplication," according to a "rules of engagement" paper issued by the three regulators. Under the pilot, participating authorities will agree to share inspection plans and inspection outcomes. Each regulator will outline inspections that they have conducted in the previous 24 to 36 months and their inspection plans for the next 18 months. This information sharing will allow regulators to determine whether they have already inspected the site, whether they plan to inspect it at the same time, or whether they have any interest in the site for some other reason. Expected deliverables and key performance indicators are increased transparency and visibility of inspections performed by participating authorities, decrease in duplicate inspections, and an overall increase in the number of API manufacturing sites inspected by participating authorities for all inspections. Since the ICH Guideline on Quality Risk Management was adopted in 2005, Australia, Europe and the U.S. have explored ways to strengthen international collaboration focused on minimizing pharmaceutical-related manufacturing risks. However, an industry observer said that the "rules of engagement" paper does not really specify whether regulators are obliged to accept the results of the other's inspections, but does "open the door" to this possibility. Negotiation of a mutual recognition agreement between the U.S. and the EU had faltered a few years ago over whether inspectorates would have to accept each others' conclusions. The observer further noted that it may be a challenge for FDA to disclose sites that it plans to inspect over the next 18 months as the agency tends to operate on a much shorter time frame

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