FDA relaxes GMP rules for Ph I candidates

July 25, 2008

The US Food and Drug Administration (FDA) has relaxed the regulatory good manufacturing practice (GMP) rules for drugs in early-stage clinical trials in recognition of the different requirements of trial scale and industrial scale manufacture.

The FDA‘s new regulatory guidance, which was detailed in a recent edition of the US Federal Register, removes the requirement that candidate drugs are produced using a fully validated manufacturing process.

The ruling, which comes into effect on September 15 and will apply to most candidate biologics, small molecules and vaccines, also removes some of the stock rotation requirements and labelling regulations that are applied to drugs produced on a commercial scale.

Drugmakers must still comply with statutory current good manufacturing practice (cGMP) guidelines and submit detailed information about their production processes as part of the investigational new drug (IND) application.

The new guidance liberates companies of some of the rules that are only really relevant to commercial scale production.

The move could encourage innovation in the drug discovery sector as it considerably lowers the cost of moving candidates from the laboratory to the clinic.

An agency spokesman explained that the: 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.”


FDA suspends GMP requirements on trial drugs

July 23, 2008

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.