• https://herbal.fda.moph.go.th/

• Guidelines on good agricultural and collection practices (GACP) for medicinal plants (2003) 

• WHO guidelines on good manufacturing practices (GMP) for herbal medicines (2007) 

• WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems (2004) 

• WHO Traditional Medicine Strategy 2014-2023 (2013) 

• WHO guidelines on good herbal processing practices for herbal medicines

• Guideline on quality of herbal medicinal products/traditional herbal medicinal products (EMA/CPMP/QWP/2819/00 Rev. 3) 

• Guideline on non-clinical documentation for herbal medicinal products in applications for marketing authorisation (EMEA/HMPC/32116/2005) (2006) 

• Guideline on the assessment of clinical safety and efficacy in the preparation of EU herbal monographs for well-established and traditional herbal medicinal products (EMA/HMPC/104613/2005 Rev. 1) (2017) 

• Botanical Drug Development Guidance for Industry (2016) 

• Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry (2022) 

• Natural Health Products Regulations (last amended 2021) 

• Management of Clinical Trials During the COVID-19 Pandemic: Notice to Clinical Trial Sponsors (2022) 

• E6(R2) Good Clinical Practice (2016) 

OECD: Various test guidelines for toxicity

Evidence guidelines for listed medicines (2022) 

1. WHO: Guidelines on good agricultural and collection practices (GACP) for medicinal plants (2003) 

2. WHO: WHO guidelines on good herbal processing practices for herbal medicines (2018) 

3. WHO: Quality control methods for herbal materials (1998, updated 2011) 

4. EMA: Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin (2006)

5. Best Practice in the chemical characterisation of extracts used in pharmacological and toxicological research—The ConPhyMP—Guidelines 2022

6. Best practice in research - Overcoming common challenges in phytopharmacological research 2020

5. WHO: WHO guidelines on good manufacturing practices (GMP) for herbal medicines (2007) Link: https://apps.who.int/iris/handle/10665/43672

6. EMA: Guideline on quality of herbal medicinal products/traditional herbal medicinal products (2011) Link: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-herbal-medicinal-products-traditional-herbal-medicinal-products-revision-2_en.pdf

7. EMA: Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products (2011) Link: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-specifications-test-procedures-acceptance-criteria-herbal-substances-herbal-preparations_en.pdf

8. FDA: Current Good Manufacturing Practice for Dietary Supplements (21 CFR Part 111) Link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=111

9. Health Canada: Good Manufacturing Practices Guidance Document for Natural Health Products (2013) Link: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/good-manufacturing-practices.html

10. ASEAN: Guidelines on Good Manufacturing Practice for Traditional Medicines and Health Supplements (2015) Link: https://asean.org/our-communities/economic-community/standard-and-conformance/

15. OECD: Various test guidelines for toxicity studies Link: https://www.oecd.org/en/publications/briefs.html?orderBy=mostRelevant&page=0

16. EMA: Guideline on non-clinical documentation for herbal medicinal products in applications for marketing authorisation (2006) Link: https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/scientific-guidelines/multidisciplinary-guidelines/herbal-medicinal-products-scientific-guidelines

17. EMA: Guideline on the assessment of genotoxicity of herbal substances/preparations (2008) Link: https://www.ema.europa.eu/en/selection-test-materials-genotoxicity-testing-traditional-herbal-medicinal-products-herbal-medicinal-products-scientific-guideline

18. FDA: Guidance for Industry: Nonclinical Safety Evaluation of Drug or Biologic Combinations (2006) Link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/nonclinical-safety-evaluation-drug-or-biologic-combinations

19. FDA: Guidance for Industry: Botanical Drug Development (2016) Link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/botanical-drug-development-guidance-industry

20. ICH: Various guidelines on clinical practice and trials Link: https://www.ich.org/page/efficacy-guidelines

21. EMA: Guidelines on clinical assessment of herbal medicinal products Link: https://www.ema.europa.eu/en/quality-herbal-medicinal-products-traditional-herbal-medicinal-products-scientific-guideline

22. FDA: Guidance for Industry: Botanical Drug Development (2016) [Clinical trial sections] Link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/botanical-drug-development-guidance-industry

23. Health Canada: Guidance Document: Clinical Trials for Natural Health Products (2011) Link: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/clinical-trials.html

24. Guidelines for randomised controlled trials investigating Chinese herbal medicine. 

35. ICH: Q1A(R2) Stability Testing of New Drug Substances and Products (2003) Link: https://database.ich.org/sites/default/files/Q1A%28R2%29%20Guideline.pdf

36. ICH: Q1B Photostability Testing of New Drug Substances and Products (1996) Link: https://database.ich.org/sites/default/files/Q1B%20Guideline.pdf

37. EMA: Guideline on stability testing of existing active substances and related finished products (2003) Link: https://www.ema.europa.eu/en/stability-testing-existing-active-substances-related-finished-products-scientific-guideline

11. WHO: General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine (2000) Link: https://apps.who.int/iris/handle/10665/66783

12. EMA: Reflection paper on markers used for quantitative and qualitative analysis of herbal medicinal products and traditional herbal medicinal products (2008) Link: https://www.ema.europa.eu/en/markers-used-quantitative-qualitative-analysis-herbal-medicinal-products-traditional-herbal-medicinal-products-scientific-guideline

13. USP: General Chapter <561> Articles of Botanical Origin Link: This is part of the USP-NF, which requires a subscription. https://www.usp.org/sites/default/files/usp/document/our-work/DS/2015-dsc-chapters-561-616-1010-1092.pdf

14. USP: General Chapter <2021> Microbial Enumeration Tests—Nutritional and Dietary Supplements Link: This is part of the USP-NF, which requires a subscription.

15. ConPhyMP tool

The Global Health Network  https://tghn.org/

Resource to conduct clinical trial https://hub.tghn.org/resources-gateway/

Environmental Risk Assessment:

38. EMA: Guideline on the environmental risk assessment of medicinal products for human use (2006) Link: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-environmental-risk-assessment-medicinal-products-human-use-first-version_en.pdf

Special Populations:

39. EMA: Reflection papers on specific herbal products and their use in children Link: https://www.ema.europa.eu/en/documents/other/overview-comments-received-reflection-paper-necessity-initiatives-stimulate-conduct-clinical-studies-herbal-medicinal-products-paediatric-population_en.pdf

Traditional Medicine Systems:

40. WHO: Global Report on Traditional and Complementary Medicine (2019) Link: https://www.who.int/publications/i/item/978924151536

Analytical Methods:

43. USP: General Chapter <621> Chromatography Link: This is part of the USP-NF, which requires a subscription.

44. USP: General Chapter <1225> Validation of Compendial Procedures Link: This is part of the USP-NF, which requires a subscription.

Sustainability and Conservation:

45. WHO: Guidelines on good agricultural and collection practices (GACP) for medicinal plants (2003) [Sections on sustainability] Link: https://apps.who.int/iris/handle/10665/42783

Intellectual Property and Traditional Knowledge:

47. WIPO: Technical Study on Disclosure Requirements in Patent Systems Related to Genetic Resources and Traditional Knowledge (2004) Link: https://www.wipo.int/edocs/pubdocs/en/tk/786/wipo_pub_786.pdf

Safety test
48. Botanical Safety consortium https://botanicalsafetyconsortium.org/