The FDA has issued new guidelines that exempt Phase I drugs from certain Good Manufacturing Practice regulations.
In issuing the exemptions–which go into effect September 15, the agency notes that GMP regulations were designed more for commercial manufacturing than for investigational products designed for a Phase I trial.
FDA News notes that Phase I products will no longer have to meet GMP 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.”
“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.
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.
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.