Genetically Modified Animal-Derived Products: From Regulations to Applications.

Area of Science:

• Biotechnology and genetic engineering
• Animal science
• Regulatory science

Background:

• Biotechnological advances enable genetically modified (GM) animals for agriculture and medicine.
• GM animal products face lower public acceptance than GM plant products.
• Regulatory frameworks and public perception are critical for GM animal commercialization.

Purpose of the Study:

• To review approved GM and gene-edited animal-derived products.
• To discuss the regulatory context and risk-based assessment for GM animals.
• To examine GM animal approvals in the US (FDA) and globally.

Main Methods:

• Literature review of approved GM animal products.
• Analysis of regulatory documents and guidelines from the FDA and other jurisdictions.
• Case-by-case evaluation of risk-based assessment strategies.

Main Results:

• Several GM and gene-edited animal products have been approved by the FDA.
• Regulatory approval involves rigorous risk-based, case-by-case assessments.
• Examples of approved GM animals from other global jurisdictions are presented.

Conclusions:

• GM animals hold significant potential for agriculture and medicine.
• Navigating regulatory landscapes and public perception is key to successful commercialization.
• The review provides insights into current approvals and regulatory approaches worldwide.