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.
CDER DRAFT GUIDANCE ON THE PROGRAM FOR THE RECOGNITION OF VOLUNTARY CONSENSUS STANDARDS RELATED TO PHARMACEUTICAL QUALITY
In February 2019, the FDA Center for Drug Evaluation and Research (CDER) issued the draft guidance for public review and comment: CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality. This guidance document describes a proposed program at CDER to make a comprehensive listing of informally recognized voluntary related to pharmaceutical quality. The program, once established, will help promote innovation in pharmaceutical development and manufacturing and streamline the compilation and assessment of marketing applications for products regulated by CDER.
NOTE: The comment period for the guidance closed on April 15, 2019; the FDA has begun work on the final version of the guidance.
CBER 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On Tuesday, December 19, 2017, the FDA Center for Biologics Evaluation and Research (CBER) issued the draft guidance for public review and comment: Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Draft Guidance for Industry and Food and Drug Administration Staff.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. The final version of the guidance was issued March 2019.
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.