Regulatory Focus™ > News Articles > IOM: Boost Foreign Regulatory Capacity to Ensure Drug Safety

IOM: Boost Foreign Regulatory Capacity to Ensure Drug Safety

Posted 04 April 2012 | By Alexander Gaffney, RAC 

A new report from the Institute of Medicine (IOM) concludes the US Food and Drug Administration (FDA) needs to make investments into advancing the regulatory capacity of developing low- and middle-income nations in order to secure the pharmaceutical supply chain and safeguard the American public.

The report, Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad, recommends 13 steps FDA and other regulatory bodies can take in the next five years to improve the regulatory systems of developing nations.

Rather than try to inspect all foreign establishments itself-something IOM conceded was unrealistic given FDA's limited budget-FDA should instead invest in improving other regulatory systems to accomplish its goals of ensuring a safe pharmaceutical supply chain, said IOM in a press release.

"The report urges FDA and its technologically advanced counterparts in the European Union, Canada, Japan, Norway, Iceland, Switzerland, Australia, and New Zealand to plan a system for mutual recognition of one another's inspections, which would eliminate the wasteful duplication of effort," wrote IOM in a statement.

FDA, the European Medicines Agency (EMA), Australia's Therapeutic Goods Administration (TGA) and the World Health Organization have all announced their participation in a global active pharmaceutical ingredient inspection program that might go a long way toward accomplishing IOM's recommendations-something IOM agrees with in principle.

"There is no need for American and European inspectors to examine the same facilities, especially when a vast number of facilities go uninspected," said IOM in a press release.

IOM also called on industry association to "define a reliable way to share internal inspection results among their members within the next three years.

Read more:

IOM - U.S. Agencies Should Take Steps to Boost Developing Nations' Regulatory Capacity to Ensure That Imported Foods and Drugs Are Safe

IOM Report Brief - Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

IOM Report - Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

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