The European Medicines Agency and regulatory authorities in the EU prepare scientific guidelines to help applicants for herbal medicine marketing authorization. The guidelines provide a harmonized approach across EU states for demonstrating quality, safety, and efficacy of herbal medicines. They include guidelines on good practices for herb cultivation and collection, quality control of herbal substances and preparations, assessing genotoxicity and clinical safety/efficacy of herbal medicines, and public statements on allergic risks and contamination issues.

1. Quality Control & Standardization Of Herbals
EU Guideline For Quality Control Of Herbal Drugs
By
Kaushal Kumar

2. Tabel Of Contents
01 02 03 04
Introduction Guidelines Quality Clinical & Non-
Clinical

3. The European Medicines Agency's (EMAs) Committee
for herbal medicinal products for human and veterinary
use prepares scientific guidelines in consultation with
regulatory authorities in the European Union (EU)
Member States, to help applicants prepare marketing
authorization applications for human and veterinary
medicines.
Guidelines reflect a harmonized approach of the EU
Member States and the Agency on how to interpret and
apply the requirements for the demonstration of quality,
safety and efficacy set out in the Community orders.
Introduction

4. Scientific Guidelines
Quality Clinical Non-Clinical Safety of Herbal
Substance

5. Scientific Guidelines
Quality
 Guidelines on the declaration of herbal substances and herbal reparations in herbal
medicinal products/traditional herbal medicinal products
☻ Standardized herbal substances
☻ Quantified herbal substances
☻ Other herbal substances
☻ Declaration of herbal preparations in the Summary of Product Characteristics
→ Standardized herbal preparations
→ Quantified herbal substances
→ Other herbal substances
→ Herbal preparations consisting of comminuted or powdered herbal substances
→ Herbal preparations produced by steps which exceed comminution/powdering

6. Scientific Guidelines
Quality
 Guidelines on Good Agricultural and Collection Practice (GACP) for Starting
Materials of Herbal Origin
☻ Quality Assurance ☻ Personnel and Education
☻ Building and Facilities ☻ Equipment
☻ Documentation ☻ Seeds and Propagation Material
☻ Cultivation ☻ Soil & Fertilization
☻ Irrigation ☻ Crop maintenance & Plant protection
☻ Collections ☻ Harvest
☻ Primary Processing ☻ Packaging
☻ Storage & Distribution

7. Scientific Guidelines
Quality
 Guideline on the quality of the combination of herbal medicine/traditional herbal
medicinal products
1. Identification test of each active substance in combination with herbal medicinal products
2. Assay of each active substance in combination with herbal medicinal products
3. The stability of the combination herbal medicinal product

8. Scientific Guidelines
Quality
 Guideline on quality of herbal medicinal products/traditional herbal medicinal
Products
 Qualitative and quantitative particulars of the active substance of a herbal medicinal product
 Herbal substances and herbal preparations consisting of comminuted or powdered herbal
substances
 Herbal preparations produced by steps, which exceed comminution
 Description of the method of preparation of the herbal medicinal product
 Control of starting materials (Control of herbal substances, herbal preparation , vit & Minerals,
excipients, test on herbal medicinal plants, stability test.
 Control tests carried out at an intermediate stage of the manufacturing process of the herbal
medicinal product
 Control tests on the herbal medicinal product
 Stability tests

9. Scientific Guidelines
Quality
 Guideline on specifications: test procedures and acceptance criteria for herbal substances,
herbal preparations and herbal medicinal products/traditional herbal medicinal products.
 Specifications: Definition and justification
Specifications for herbal substances, Preparations, Medicinal Products linked
 Universal tests/criteria
⭧ Herbal Substance (Definition, character, Identification, Tests, Particle Size, Water Content, Contaminants)
⭧ Herbal Preparations
⭧ Vitamin & Minerals in traditional herbal medicinal products (Identification, Assay, Impurities)
⭧ Herbal medicinal products (tablets, oral liquids)
 Specific tests/criteria (Tablets, Syrup)

10. Scientific Guidelines
Non-clinical Guidelines
 Guideline on the assessment of genotoxicity of herbal substances/preparations
 (Ames Test, Mouse Lymphoma Assay/ Mamallian cell assay, in-vivo genotoxicity test, Risk
assessment)
 Guideline on non-clinical documentation in applications for marketing Authorization /
registration of well-established and traditional herbal medicinal products
 General Aspect, Geno toxicity, carcinogenicity, reproductive & Development toxicity, Non
clinical overview)
 Guideline on selection of test materials for genotoxicity testing for traditional herbal medicinal
products/herbal medicinal products

11. Scientific Guidelines
Clinical Guidelines
 Guideline on the assessment of clinical safety and efficacy in the preparation of EU herbal
monographs for well-established and traditional herbal medicinal products
1. Guidance on monographs and on the list of traditional herbal substances/preparations
2. Guidance on monographs for well-established herbal medicinal products
3. Reference to active substances and products
4. Clinical safety

12. Scientific Guidelines
Clinical Guidelines
 Guideline on the clinical assessment of fixed combinations of herbal
substances/herbal preparations
1. Indications
2. Composition and dosage regimen
3. Pharmacokinetic and Pharmacodynamics Data

13. Scientific Guidelines
Safety of Herbal Substances /Products
 Public statement on the allergenic potency of herbal medicinal products containing
soya or peanut protein
 Public Statement on Capsicum Containing Herbal Medicinal Products
 Public Statement on Chamomilla Containing Herbal Medicinal Products
 Public statement on contamination of herbal medicinal products
 Statement on Environmental Risk Assessment of Herbal Medicinal Products
 Public Statement on the Use of Herbal Medicinal Products

14. THANKS!
Do you have any questions?
easyconceptkaushal@gmail.com
+91 9546688666