Healthcare and pharmaceutical TRL evidence

Healthcare assessments add regulatory and clinical-development context, including in-vitro work, animal studies, DCGI approvals, GMP pilot lots, clinical trials, and post-market surveillance.

• • TRL 3: preliminary in-vivo proof of concept and candidate characterization.
• • TRL 5: DCGI Phase 1 approval and a draft target product profile.
• • TRL 6: GMP pilot lots and completed Phase 1 clinical trials.
• • TRL 8: Phase 3 completion, NDA or BLA submission, and approval pathway evidence.
• • TRL 9: commercial launch and Phase 4 post-marketing surveillance.

Source: NTRAF Annexure A