Gene Editing

13.

Regulation and Governance

13.1.

National Regulatory Frameworks

13.1.1.

13.1.1.1.

Food and Drug Administration

13.1.1.1.1.

Biologics Regulation

13.1.1.1.2.

Clinical Trial Oversight

13.1.1.1.3.

Approval Pathways

13.1.1.2.

National Institutes of Health

13.1.1.2.1.

Research Funding Guidelines

13.1.1.2.2.

Recombinant DNA Advisory Committee

13.1.1.3.

Centers for Disease Control

13.1.1.3.1.

Public Health Oversight

13.1.2.

13.1.2.1.

European Medicines Agency

13.1.2.1.1.

Centralized Approval Process

13.1.2.1.2.

Scientific Advice

13.1.2.2.

National Competent Authorities

13.1.2.3.

GMO Regulations

13.1.2.3.1.

Environmental Release

13.1.2.3.2.

Food and Feed Safety

13.1.3.

Other Major Jurisdictions

13.1.3.1.

13.1.3.1.1.

National Medical Products Administration

13.1.3.1.2.

Recent Policy Developments

13.1.3.2.

13.1.3.2.1.

Pharmaceuticals and Medical Devices Agency

13.1.3.3.

13.1.3.3.1.

Health Canada Oversight

13.1.3.4.

13.1.3.4.1.

Therapeutic Goods Administration

13.2.

International Coordination

13.2.1.

World Health Organization

13.2.1.1.

Global Standards Development

13.2.1.2.

Technical Guidance

13.2.1.3.

Capacity Building

13.2.2.

International Summits

13.2.2.1.

Human Genome Editing Summits

13.2.2.2.

Scientific Society Meetings

13.2.2.3.

Policy Conferences

13.2.3.

Professional Organizations

13.2.3.1.

National Academies

13.2.3.2.

Scientific Societies

13.2.3.3.

Ethics Committees

13.3.

Regulatory Challenges

13.3.1.

Keeping Pace with Technology

13.3.2.

International Harmonization

13.3.3.

Risk-Benefit Assessment

13.3.4.

Public Engagement

13.3.5.

Adaptive Regulation

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12. Ethical, Legal, and Social Implications

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14. Future Directions and Emerging Technologies