Existing Standards & Best Practices
As part of its mission, SCB seeks to keep its stakeholders and the entire regenerative medicine community abreast of any relevant additions, updates, or other modifications to the standards landscape.
Regenerative Medicine Standards Landscape Report
In 2018, Nexight Group LLC and SCB co-authored The Regenerative Medicine Standards Landscape report with funding from the U.S. Food and Drug Administration (FDA). This report provides an overview of nearly 200 existing standards relevant to the cell therapy, gene therapy, or tissue engineering sectors of regenerative medicine and assesses the needs and opportunities for standards development in regenerative medicine as identified by key stakeholders.
This report will be regularly updated to provide the most comprehensive list of existing regenerative medicine standards and to identify needed standards in response to the rapidly developing regenerative medicine field.
Guidance and Regulations
Standards development requires close interaction with federal agencies that issue guidance documents and regulations:
Guidance: Formal statements of federal government agency policy with respect to laws or regulations
Regulations: Have the force and effect of law and are generally mandatory, setting out specific requirements that regulated products and entities must meet. In the United States, regulations are written (codified) in the Code of Federal Regulations (CFR) and published in the Federal Register (FR).
The following guidance documents and regulations are relevant to the regenerative medicine standards landscape.
CBER DRAFT GUIDANCE ON STANDARDS DEVELOPMENT AND THE USE OF STANDARDS IN REGULATORY SUBMISSIONS
On Tuesday, December 19, 2017, the FDA Center for Biologics Evaluation and Research (CBER) issued the draft guidance for public review and comment: Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Draft Guidance for Industry and Food and Drug Administration Staff. This guidance document describes what standards are and how they are developed by Standards Development Organizations (SDOs). The guidance document also addresses questions on how sponsors can use standards to facilitate product development and regulatory submissions, and acceptance of such use of standards by the FDA.
NOTE: The comment period for the guidance closed on March 19, 2018; the FDA has begun work on the final version of the guidance.
FDA STERILITY REGULATION 21 CFR 610.12
In 2012, the FDA amended the sterility test requirements for biological products. This rule provided manufacturers of biological products greater flexibility, as appropriate, and encouraged the use of the most appropriate and state-of-the-art testing methods for assuring the safety of biological products.