Direct Links to important GMP Biologic Guidelines

Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products

This guidance provides recommendations to industry on formal meetings between the Food and Drug Administration (FDA) and sponsors or applicants relating to the development and review of drug or biological drug products (hereafter products) regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

FDA Guidance for Industry: Safety Considerations for Product Design to Minimize Medication Errors

The recommendations in this guidance apply broadly to the development of drug and biologic products. Accordingly, this guidance is intended for sponsors of investigational new drug applications (INDs); applicants of new drug applications (NDAs), biologics licensing applications (BLAs), abbreviated new drug applications (ANDAs); and manufacturers of prescription drugs marketed without an approved application or over-the-counter (OTC) monograph drugs.

FDA Draft Guidance for Industry: Potency Assurance for Cellular and Gene Therapy Products

The scope of this guidance is limited to ensuring the effectiveness of CGT products regulated as biological products under Section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262). This guidance provides recommendations for ensuring the effectiveness of CGT products at all stages of their product life cycle. For investigational products, it explains how to implement a step-by-step strategy to ensure efficacy during product development. It also provides specific considerations for ensuring the efficacy of products undergoing rapid clinical development.

FDA Deaft Duidance for Industry: Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products

Human cell and gene therapy (CGT) products are manufactured and controlled within the existing regulatory framework for biological products. They can be affected by factors such as limited knowledge of product quality attributes, lack of manufacturing experience, limited and variable starting materials, low amount of product, complex manufacturing processes and limited product shelf-life. These aspects can make managing manufacturing changes more difficult than for other biological products. This complexity poses a major challenge. The FDA therefore published a draft guidance in August 2023 to provide recommendations to both Investigational New Drug Applicants (INDs) and Biologics License Applicants (BLAs) on how to compare products and manage manufacturing changes for investigational and licensed CGT products.

ICH E2F DEVELOPMENT SAFETY UPDATE REPORT

The main focus of the DSUR is data from interventional clinical trials (referred to in this document as "clinical trials") of investigational drugs including biologicals, with or without a marketing approval, whether conducted by commercial or non-commercial sponsors.

Eudralex Volume 9 Product- or Population-Specific Considerations II: Biological medicinal products

Biological medicinal products

FDA Guidance for Industry: Submission of Quality Metrics Data

This revised draft guidance includes an explanation of how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) intend to utilize submitted data and quality metrics to help ensure that their policies and practices continue to support continuous improvement and innovation in the pharmaceutical manufacturing industry.

FDA Guidance for Industry: CMC Postapproval Manufacturing Changes for Specific Biological Products To Be Documented in Annual Reports

This guidance provides recommendations to holders of biologics license applications (BLAs) for specified products regarding the types of changes to an approved BLA to be documented in an annual report under 21 CFR 601.12.

ICH Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

This guideline describes approaches to developing and understanding the manufacturing process of the drug substance, and also provides guidance on what information should be provided in Module 3 of the Common Technical Document (CTD).

Eudralex Volume 3 ICH Guideline Q11 on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

This guideline describes approaches to developing process and drug substance understanding and also provides guidance on what information should be provided in CTD sections 3.2.S.2.2 - 3.2.S.2.6. It provides further clarification on the principles and concepts described in ICH guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10) as they pertain to the development and manufacture of drug substance.

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