FDA Plans Draft Guidance Reducing Manufacturing Supplements

The FDA will no longer accept submissions for approximately 50 types of manufacturing supplements, according to a draft guidance the agency plans to release in the next few months, Helen Winkle, director of the Center for Drug Evaluation and Research’s Office of Pharmaceutical Science, said.

“We’re getting ready to put out a guidance within the next few months [that] will list a number of supplements that we no longer feel like we will require,” Winkle said at the 2007 Parenteral Drug Association/FDA Joint Regulatory Conference in Washington, D.C.

The FDA told MQN that supplements filed when manufacturers change from one reliable raw materials vendor to another would no longer be required. The guidance will list other supplements that are not required by the FDA yet are still submitted to the agency. One such supplement includes the testing site change submission.

In addition to the new draft guidance in development, the FDA intends to promulgate revisions to 21 CFR 314.70, the regulation covering the types of manufacturing changes firms must receive FDA approval for prior to implementation, Winkle said. She hopes the draft regulation will be released by the end of the year.

“The most significant proposal is to allow for a category of changes that do not need to be reported to the application,” the FDA told MQN. “These would be handled through risk assessments specified within the companies’ internal change control systems.”

In connection with the revised rule, the FDA intends to issue a more extensive guidance on change control, which will likely be released before the draft rule is issued, Winkle said.

Changes to manufacturing requirements for biologic drug products also are under consideration at the FDA, Chris Joneckis, senior advisor for chemistry, manufacturing and control issues at the Center for Biologics Evaluation and Research, said during the conference.

“We are internally upgrading and revising, both administratively and scientifically, how we do our assessing of assays for those products that have lot release … and looking at our lot release process,” Joneckis said.