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. 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/

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. 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

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

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/

1. Web application for writing protocol 

2.