By Lucas Laursen

Regulatory authorities such as the US Food and Drug Administration and European Medicines Agency face continual criticism for their plodding pace of drug approval decisions. In 2009, the last year for which complete data are available, the median time for a standard review of a drug application in the US was 13 months—30% longer than the agency’s target for such reviews. But even with this situation, it’s undeniable that both agencies devote far more human and financial resources to the process than most other countries can afford to spend on their own.

To keep up, many other medical regulatory authorities are banding together with one another to share the expertise and clinical results needed to make faster decisions. On 20 June, for example, New Zealand’s Prime Minister John Key announced that the establishment of the Australia New Zealand Therapeutic Products Agency—stalled for several years—would proceed as planned. And, the month before, as the World Health Organization (WHO) held its annual assembly in Geneva, a concurrent meeting of health ministers from countries in the Gulf Cooperation Council approved pricing standards for drugs in its six member states from across the Arabian Peninsula.

“There is increasing cooperation and work sharing between regulators,” says Lembit Rägo, coordinator of Quality Assurance and Safety for Medicines at the WHO in Geneva and author of an April 2011 report on international harmonization of regulatory efforts (Clin. Pharmacol. Ther. 89, 503–512, 2011).

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