FDAnews Drug Daily Bulletin

FDA Moves Forward With Exempting Phase I Drugs From GMPs

July 16, 2008

More than two years after withdrawing a final rule that would have exempted investigational drugs in Phase I testing from certain good manufacturing practice (GMP) regulations, the FDA is issuing a final rule to do just that.

The new rule, which amends the GMP regulation with the exact same language as the withdrawn rule, was published in Tuesday’s Federal Register. Slated to take effect Sept. 15, it will apply to small-molecule drugs and biologics, including vaccines and gene therapy products.

“FDA’s position is that the United States’ [GMP] regulations were written primarily to address commercial manufacturing and do not consider the differences between early clinical supply manufacture and commercial manufacture,” the agency says.

For example, the requirements for a fully validated manufacturing process, rotation of stock for drug product containers, repackaging and relabeling of drugs and separate packaging and production areas need not apply to investigational drug products made for use in Phase I trials, the agency says.

In connection with the final rule on Phase I drug GMPs, the FDA issued a guidance recommending approaches to satisfy statutory GMP requirements for such drugs.

“During product development, the quality and safety of Phase I investigational drugs are maintained, in part, by having appropriate [quality control (QC)] procedures in effect,” the guidance states. “Using established or standardized QC procedures and following appropriate cGMP will also facilitate the manufacture of equivalent or comparable IND product for future clinical trials as needed.”

More information on the final rule can be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/oc07114.pdf. A copy of the guidance, “CGMP for Phase 1 Investigational Drugs,” can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2005-D-0157-gdl.pdf.