FDA Guidance for Industry

Regulatory professionals and product developers, scientists and investors are all wondering, how does/will the urgent need for a COVID vaccine affect the CMC regulatory landscape, are rules changing, are standards changing, what does ‘acceleration’ mean? Today FDA released the Final Guidance for Industry:  Development and Licensure of Vaccines to Prevent COVID-19. 

“This guidance provides an overview of key considerations to satisfy regulatory requirements set forth in the investigational new drug application (IND) regulations in 21 CFR Part 312 and licensing regulations in 21 CFR Part 601 for chemistry, manufacturing, and controls (CMC), and nonclinical and clinical data through development and licensure, and for post-licensure safety evaluation of COVID-19 preventive vaccines.”

In this document FDA provides guidance on the expectations for COVID related CMC development.  In summary, the need for product specific data for your product can be reduced by leveraging the science related to your product, using common sense, and following established guidelines.

Messages:

• Statutory and regulatory requirements for vaccine development and approval apply to COVID-19 vaccines and other related/unrelated vaccines.
• FDA provides concepts to IND sponsors for leveraging existing data packages to facilitate FDA review and approvals.
• FDA guidances to industry still apply.

Leveraging Data for Acceleration:

• Vaccine development may be accelerated based on knowledge gained from similar products manufactured with the same well-characterized platform technology, to the extent legally and scientifically permissible.
• With appropriate justification, some aspects of manufacture and control may be based on the vaccine platform, and in some instances, reduce the need for product specific data.

References in the COVID guidance for industry:

• Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product, January 1999.
• Guidance for Industry: Considerations For Plasmid DNA Vaccines For Infectious Disease Indications, November 2007.
• Guidance for Industry: Process Validation: General Principles and Practices, January 2011.