The World Health Organization (WHO) provides guidelines for evaluating the quality, safety, and efficacy of herbal medicines.
These guidelines help establish a regulatory framework ensuring their proper use based on traditional knowledge and scientific evidence.
Objectives
Promote the safety, efficacy, and quality of herbal medicines.
Guide the assessment of botanical, chemical, pharmacological, and toxicological aspects.
Provide methodologies for research and evaluation of herbal drugs.
Support the standardization and regulation of herbal medicines.
Encourage the conservation of medicinal plants and respect for indigenous knowledge.
Key Aspects of Assessment
1) Quality Assessment
Evaluates the physical, chemical, and biological properties of plant material.
Uses macroscopic, microscopic, organoleptic, and chromatographic techniques.
2) Safety Assessment
Determines the toxicological profile of herbal drugs.
Includes acute, sub-acute, chronic toxicity, genotoxicity, and carcinogenicity studies.
3) Efficacy Assessment
Examines therapeutic properties through pharmacological and clinical tests.
Uses animal models, human clinical trials, and systematic reviews.
4) Standardization
Establishes specifications for plant materials and finished products.
Uses reference standards, marker compounds, and chemical fingerprinting.
5) Manufacturing
Ensures compliance with Good Manufacturing Practices (GMP).
Covers the preparation, processing, and quality control of herbal drugs.
