Malaysia Allows Active Ingredients Claimed on the Label of Health Supplements to Be “Quantified by Input”

On November 9, 2022, the National Pharmaceutical Regulatory Agency (NPRA) of the Ministry of Health Malaysia issued a “Guidance on the Acceptance Criteria of Quantification by Input (QBI) of Active Ingredients Claimed on Label of Traditional Medicine and Health Supplement (TMHS) Products” to explain the situations in which the active ingredients in TMHS products could be quantified by input.

This guidance document describes the criteria for QBI to be accepted at which quantitative assay can be excluded for active ingredient claimed on the label of TMHS finished product. This guidance does not override or replace the need to comply with DRGD requirements.