CBER Finalizes Guidance on Use of Standards in Regulatory Submissions

Regulatory NewsRegulatory News | 25 March 2019 |  By 

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Monday finalized guidance on the use of standards in product development and the use of such standards in CBER’s review process.

The 10-page guidance, finalizing a draft from December 2017, offers a series of questions and answers ranging from “What is a standard?” to “How are voluntary standards developed?” to “What is CBER’s policy on accepting standards used in regulatory submissions?”

And while the guidance “does not endorse the activities of specific Standards Development Organizations (SDOs) or recommend specific standards for use in regulatory submissions,” it does explain how the wider use of voluntary consensus standards “can facilitate development by reducing the need to develop unique methods and/or reference materials for individual products.”

In terms of CBER’s policy on the use of standards in regulatory submissions, the guidance expands on what was written in the draft, with more information on reference materials/physical standards, compendial standards and data standards.

“The sponsor should provide information on the reference standards or reference materials used for testing the drug substance or drug product in the regulatory submission,” the guidance says. “CBER recommends providing the source and lot number, expiration date, certificates of analyses when available, and/or internally or externally generated evidence of identity and purity for each reference standard.”

As for data standards, the guidance says they “can help promote effective and efficient review of regulatory submissions. Examples of data standards include Structured Product Labeling, Health Level 7 Stability Standard, etc.” Submission data standards are listed in the FDA Data Standards Catalog.

And if a product is regulated by CBER as a device, the guidance also points to a list of recognized consensus standards from FDA’s Center for Devices and Radiological Health.

CBER also says it may, in some cases, take accreditation standards into consideration when assessing compliance to regulatory requirements. “Examples of accreditation organizations include AABB (transfusion medicine and cellular therapies), Foundation for the Accreditation of Cellular Therapy (cellular therapy), International Council for Commonality in Blood Banking Automation (identification and labeling of blood and tissues), and American Association of Tissue Banks (tissue banking),” the guidance says.

And although the World Health Organization (WHO) does not meet CBER’s definition of an SDO, the guidance says WHO and the standards it develops “have a role in the development, manufacturing, and use of certain medical products.”

Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research: Guidance for Industry


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