ML3 means the regulator is a stable, well-functioning and integrated system, judged against more than 260 sub-indicators across its core functions (WHO, 2022). Reaching ML3 also makes a regulator eligible for evaluation as a WHO Listed Authority.
The nine functions benchmarked are: national regulatory system (governance and law), registration and marketing authorisation, vigilance, market surveillance and control, licensing of establishments, regulatory inspection, laboratory testing, clinical trial oversight, and NRA lot release (Government of India summary of the GBT).
The practical test at ML3 is evidence, not intent. Assessors look for an approved procedure, records showing it was used, trained people doing it, and data showing it works. Critical sub-indicators that are not met block the level regardless of the overall score.
