Module 6

04/10/2024

69

Monograph vs. NDA

OTC monograph procedures

NDA procedure

Drug substance and intended use

Specific drug product and intended use

What is approved for OTC use?

Public process with no data protection

Proprietary process with data protection

Confidentiality and data protection

Clinically proven

Clinically proven

Safety and efficacy criteria for approval

Compendial and GMP Application specific dossier and GMP

CMC criteria for approval

The Organisation for Professionals in Regulatory Affairs

69

70

How are NDAs and Monographs Different?

NDA

Monograph

Pre-approval Required

Pre-approval Not Required

Clinical studies and user fees may be necessary

Clinical studies not necessary and no user fees

Approved labeling is unique to your drug

Labeling is the same for all similar drugs

Possible marketing exclusivity

No marketing exclusivity

Approved NDA is your license to market

Final monograph is open to anyone

The Organisation for Professionals in Regulatory Affairs

70

35