WHO Guidelines for the Assessment of Herbal Drugs

• 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

2. Safety Assessment

   • Determines the toxicological profile of herbal drugs.
   • Includes acute, sub-acute, chronic toxicity, genotoxicity, and carcinogenicity

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).
6. Covers the preparation, processing, and quality control of herbal drugs.

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