East Asian Regulators Collaborate To Reduce Drug Lags (Part 2 of 2)
This article was originally published in PharmAsia News
Executive Summary
[Editor's note: This is part two of a two-part story. The first part appeared in PharmAsia News, April 17, 2008.]
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Risk management program follows drug from first-in-human to post-market, gathering safety data.
Japan Launches ‘Safety Net’ Initiative As PMDA Looks To Resolve Drug Lag With The West (Part 1 of 2)
TOKYO - Japan's Pharmaceuticals and Medical Devices Agency has started a new pilot program for risk management, tentatively being called the "product management" initiative. Under the initiative, a group will be created within PMDA's Office of Safety to oversee a new drug throughout its life cycle. Initial plans called for only a handful of drugs being involved. The agency hopes to finish the pilot program within six months, in time for the initiative to be operational some time in the spring