The International Conference on Harmonisation (ICH) provides guidelines for evaluating the quality, safety, and efficacy of herbal drugs.
These guidelines help harmonize regulatory requirements across different regions.
Objectives
Establish a harmonized regulatory framework for herbal drugs.
Provide guidance on assessing active pharmaceutical ingredients (APIs) of herbal origin.
Standardize procedures for clinical evaluation of herbal medicines.
Recommend approaches for preclinical safety evaluation.
Identify and address potential public health risks.
Key Aspects of Assessment
1) Quality Assessment
Evaluates physical, chemical, and biological properties.
Uses macroscopic, microscopic, organoleptic, and chromatographic methods.
2) Safety Assessment
Assesses toxicological profile using acute, sub-acute, chronic toxicity, genotoxicity, and carcinogenicity studies.
3) Efficacy Assessment
Examines therapeutic properties using pharmacological and clinical tests such as animal models, human 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) for herbal drug preparation and processing.
Key ICH Guidelines by Category
1) Quality Guidelines (Q)
Ensure product quality. Key guidelines:
Q1A (R2): Stability Testing of New Drug Substances and Products
Q2 (R1): Validation of Analytical Procedures
Q3A (R2): Impurities in New Drug Substances
Q5A (R1): Viral Safety Evaluation for Biotechnology Products
2) Safety Guidelines (S)
Ensure drug safety. Key guidelines:
S1A: Need for Carcinogenicity Studies
S2 (R1): Genotoxicity Testing
S5 (R3): Toxicity to Reproduction and Male Fertility
3) Efficacy Guidelines (E)
Ensure therapeutic efficacy. Key guidelines:
E3: Structure and Content of Clinical Study Reports
E6 (R2): Good Clinical Practice
E9: Statistical Principles for Clinical Trials
4) Multidisciplinary Guidelines (M)
Cover cross-category aspects. Key guidelines:
M3 (R2): Nonclinical Safety Studies for Human Clinical Trials and Marketing Authorization
M7 (R1): Control of DNA Reactive (Mutagenic) Impurities
