FDA Harmonization Moves With USP And Europe

The US federal government encourages all agencies to take part instandard-setting organizations leading to harmonization, Roger Williams, Deputy Director for Pharmaceutical Science at the US Food and Drug Administration's Center for Drug Evaluation and Research, told the annual Pharm Tech conference (Marketletter September 22). This helps facilitate trade and reduce trade barriers, he said.

The Office of Policy coordinates the FDA's participation in many such organizations. Offering guidance does not set standards, he said, nor give companies information on how to develop data and submit it for New Drug Applications and Abbreviated NDAs, but it allows the FDA to set standards based on data submitted.

A key transition is being made from a private-standards to a public-standards policy, through organizations such as the United States Pharmacopoeia. The post-approval period presents a challenge due to the overlap of private and public standards, he noted, and while the FDA/USP relationship provides a wonderful system, it could be better. There are some challenges with this association, too, eg determining the limits to the information that the FDA can share with the USP, private vs public standards and harmonization.