Draft CDER Consensus Standard Guidance
FDA has released a draft guidance, CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality, describing a proposed program to make public a comprehensive listing of informally recognized voluntary consensus standards related to pharmaceutical quality. “CDER is issuing this guidance to obtain public comments on the proposed program,” the document says. “After CDER considers submitted comments, CDER will establish this program and describe it by publishing a final guidance.”
Once established, the draft says, the program will facilitate submissions by external stakeholders and CDER staff proposing voluntary consensus standards related to pharmaceutical quality for informal recognition. “CDER believes this informal program … will help promote innovation in pharmaceutical development and manufacturing and streamline the compilation and assessment of marketing applications for products regulated by CDER,” it says.
“Even if an applicant decides to use one of CDER’s informally recognized voluntary standards, CDER may request that the applicant provide additional information to support an IND application or a marketing application,” the draft says, “FDA will provide transparency regarding its thinking on a particular standard, which will help industry compile information for applications, can streamline FDA’s assessment, and allow the agency to focus its efforts on developing guidance on other quality topics.
In a statement announcing release of the draft, FDA commissioner Scott Gottlieb writes that the agency’s “recognition of a standard may also reduce regulatory uncertainty, allowing applicants and manufacturers to utilize new or innovative approaches within their development programs. Once we’ve recognized a standard, applicants will generally not have to validate the approach outlined in the standard and can instead focus on appropriate use of the method and the acceptance criteria. We’ll similarly be able to streamline assessment of applications that reference recognized standards. Our hope is that establishing this program will also encourage development of standards for emerging technologies that can improve the drug quality and reduce manufacturing costs. This includes continuous manufacturing. Informally recognized standards related to pharmaceutical quality will also be publicly available on our Web site.”
The program does not change any legal requirements such as provisions of the Federal Food, Drug, and Cosmetic Act relating to the U.S. Pharmacopeia, Gottlieb says. But, he says, it will facilitate recognition of other standards concerning pharmaceutical quality to make the adoption of advances in drug manufacturing and application review more efficient and encourage innovation in how drugs are manufactured.