Submitting a Monograph

Technical Information Requirements For Monograph Review

Approved April 2014

12. References Regarding General Requirements For Submissions

1. Homeopathic Pharmacopeia of the United States. www.hpus.com.

2. United States Pharmacopoeia. General Chapters. www.usp.org.

3. European Pharmacopoeia. General Chapters. www.edqm.eu.

4. Guidance for Industry. Botanical Drug Products. U.S. Department of Health and Human Services. Food and Drug Administration. December 2016. Last downloaded April 25, 2023 from online at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/botanical-drug-development-guidance-industry.

5. Guidance for Industry. INDs for Phase 2 and Phase 3 Studies, Chemistry Manufacturing and Controls Information. U.S. Department of Health and Human Services. Food and Drug Administration. May 2003. Last downloaded April 10, 2013 from on line at  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070567.pdf.

6. Guidance for Industry. Residual Solvents in Drug Products Marketed in the United States. U.S. Department of Health and Human Services. Food and Drug Administration. November 2009. Last downloaded April 10, 2013 from online at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070621.pdf.

7. Guidance for Industry. Analytical Procedures and Methods Validation, for Drugs and Biologics. U.S. Department of Health and Human Services. Food and Drug Administration. Draft Guidance. July 2015. Last downloaded April 25, 2023 from online at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/analytical-procedures-and-methods-validation-drugs-and-biologics.

8. Homeopathic Medicinal Products Working Group (HMPWG). Guidance on Module 3 of the Homeopathic Medicinal Products Dossier. November 2007. Last downloaded April 27, 2023 from online at https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/2007_11_HMPWG_dossier_guidance_mod3.pdf.

9. Homeopathic Medicinal Products Working Group (HMPWG). Points to Consider on Safety of Homeopathic Medicinal Products of Biological Origin. April 2016. Last downloaded April 27, 2023 from online at https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/2016_05_HMPWG_PtC_Biological.pdf.

10. Homeopathic Medicinal Products Working Group (HMPWG). Guidance on Non-Clinical Documentation in Applications for Registration of Homeopathic Medical Products for Human Use. November 2021. Last downloaded April 27, 2023 from online at https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/HMPWG_Guidance_on_non-clinical_documentation_in_applications_for_registration.pdf.

11. Homeopathic Medicinal Products Working Group (HMPWG). Points to Consider on Stability Testing of Homeopathic Medicinal Products. July 2009. Last downloaded April 27, 2023 from on line at https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/2009_07_Points_on_Stability_testing.pdf.

12. Homeopathic Medicinal Products Working Group (HMPWG). Points to Consider  on Safety of Homeopathic Medicinal Products of Biological Origin. July 2007. Last downloaded August 1, 2013 from online at http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/2007_07_safety_MP_BO.pdf.

13. Homeopathic Medicinal Products Working Group (HMPWG) Introduction to the List of First Safe Dilutions. May 10, 2010 Last downloaded August 1, 2013 from online at http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/2010_05_HMPWG_First_Safe_Dilutions.pdf.

14. Homeopathic Medicinal Products Working Group (HMPWG) Structure of the List of First Safe Dilutions. May 10, 2010 Last downloaded April 27, 2023 from online at https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/2010_05_HMPWG_Stucture_of_List_of_FSD.pdf.

15. Homeopathic Medicinal Products Working Group (HMPWG) Assessment Report Template  First Safe Dilution. May 10, 2010 Last downloaded August 1, 2013 from online at: http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/2010_05_FSD_assessment_report_list.pdf.

16. International Conference on Harmonisation (ICH). Q1A Stability Testing of New Drug Substance and Products. February 2003. Last downloaded April 10, 2013 from online at  http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-of-new-drug-substances-and-products.html.

17. International Conference on Harmonisation (ICH). Q1B Stability Testing: Photostability Testing of New Drug Substances and Products. November 1996. Last downloaded April 10, 2013 from online at http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-photostability-testing-of-new-drug-substances-and-products.html.

18. International Conference on Harmonisation (ICH). Q1C Stability Testing for New Dosage Forms. November 1996. Last downloaded April 10, 2013 from online at  http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-for-new-dosage-forms.html.

19. International Conference on Harmonisation (ICH). Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products. February 2002. Last downloaded April 10, 2013 from online at http://www.ich.org/products/guidelines/quality/quality-single/article/bracketing-and-matrixing-designs-for-stability-testing-of-new-drug-substances-and-products.html.

20. International Conference on Harmonisation (ICH). Q1E Evaluation for Stability Data. February 2003. Last downloaded April 10, 2013 from online at http://www.ich.org/products/guidelines/quality/quality-single/article/evaluation-of-stability-data.html.

21. World Health Organization, WHO Technical Report Series No. 953 2009. Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products. Last downloaded April 10, 2013 from online at http://www.scribd.com/doc/38700550/Who-Technical-Report-Series-No-953-2009.

22. International Conference on Harmonisation (ICH). Q2 Validation of Analytical Procedures: Text and Methodology. October 1994/November 1996. Last downloaded April 10, 2013 from online at http://www.ich.org/products/guidelines/quality/quality-single/article/validation-of-analytical-procedures-text-and-methodology.html.

23. International Conference on Harmonisation (ICH). Q3A Impurities in New Drug Substances. October 2006. Last downloaded April 10, 2013 from online at http://www.ich.org/products/guidelines/quality/quality-single/article/impurities-in-new-drug-substances.html.

24. International Conference on Harmonisation (ICH). Q3B Impurities in New Drug Products. June 2006. Last downloaded April 10, 2013 from online at http://www.ich.org/products/guidelines/quality/quality-single/article/impurities-in-new-drug-products.html.

25. International Conference on Harmonisation (ICH). Q3C Impurities: Guideline for Residual Solvents. February 2011. Last downloaded April 10, 2013 from online at http://www.ich.org/products/guidelines/quality/quality-single/article/impurities-guideline-for-residual-solvents.html.

26. International Conference on Harmonisation (ICH). Q5A Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. September 1999. Last downloaded April 10, 2013 from online at http://www.ich.org/products/guidelines/quality/quality-single/article/viral-safety-evaluation-of-biotechnology-products-derived-from-cell-lines-of-human-or-animal-origin.html.

27. International Conference on Harmonisation (ICH). Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. October 1999. Last downloaded April 10, 2013 from online at http://www.ich.org/products/guidelines/quality/quality-single/article/specifications-test-procedures-and-acceptance-criteria-for-new-drug-substances-and-new-drug-produc.html.

28. International Conference on Harmonisation (ICH).  Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. March 1999. Last downloaded April 10, 2013 from online at http://www.ich.org/products/guidelines/quality/quality-single/article/specifications-test-procedures-and-acceptance-criteria-for-biotechnologicalbiological-products.html.

29. International Conference on Harmonisation (ICH). Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. November 2007. Last downloaded April 10, 2013 from online at http://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.html.

30. Guidance for Industry Single Dose Acute Toxicity Testing for Pharmaceuticals U.S. Department of Health and Human Services. Food and Drug Administration. Draft Guidance. August 1996.   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079270.pdf.

31. International Conference on Harmonisation (ICH). S1A Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals. November 1995.  Last downloaded April 10, 2013 from online at http://www.ich.org/products/guidelines/safety/safety-single/article/need-for-carcinogenicity-studies-of-pharmaceuticals.html.

32. International Conference on Harmonisation (ICH). S1B Testing for Carcinogenicity of Pharmaceuticals. July 1997. Last downloaded April 10, 2013 from online at http://www.ich.org/products/guidelines/safety/safety-single/article/testing-for-carcinogenicity-of-pharmaceuticals.html.

33. International Conference on Harmonisation (ICH). S1C Dose Selection Studies for Carcinogenicity Studies of Pharmaceuticals March 2008. Last downloaded April 10, 2013 from online at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S1C_R2/Step4/S1C_R2__Guideline.pdf.

34. International Conference on Harmonisation (ICH). S2 Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use. November 2011. Last downloaded April 10, 2013 from online at http://www.ich.org/products/guidelines/safety/safety-single/article/guidance-on-genotoxicity-testing-and-data-interpretation-for-pharmaceuticals-intended-for-human-use.html.

35. International Conference of Harmonisation (ICH). S3A Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies. October 1994. Last downloaded April 10, 2013 from online at http://www.ich.org/products/guidelines/safety/safety-single/article/note-for-guidance-on-toxicokinetics-the-assessment-of-systemic-exposure-in-toxicity-studies.html.

36. International Conference of Harmonisation (ICH). S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies. October 1994. Last downloaded April 10, 2013 from online at http://www.ich.org/products/guidelines/safety/safety-single/article/pharmacokinetics-guidance-for-repeated-dose-tissue-distribution-studies.html.

37. International Conference of Harmonisation (ICH). S4 Duration of Chronic Toxicity Testing in Animals (Rodent and NON Rodent Toxicity Testing). September 1998. Last downloaded April 10, 2013 from online at http://www.ich.org/products/guidelines/safety/safety-single/article/duration-of-chronic-toxicity-testing-in-animals-rodent-and-non-rodent-toxicity-testing.html.

38. International Conference of Harmonisation (ICH). S5 Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility. November 2000. Last downloaded April 10, 2013 from online at http://www.ich.org/products/guidelines/safety/safety-single/article/detection-of-toxicity-to-reproduction-for-medicinal-products-toxicity-to-male-fertility.html.

39. International Conference of Harmonisation (ICH). S6 Preclinical Safety Evaluation of Biotechnology – Derived Pharmaceuticals. June 2011. Last downloaded April 10, 2013 from online at http://www.ich.org/products/guidelines/safety/safety-single/article/preclinical-safety-evaluation-of-biotechnology-derived-pharmaceuticals.html.

40. International Conference of Harmonisation (ICH). S7A Safety Pharmacology Studies for Human Pharmaceuticals. November 2000. Last downloaded April 10, 2013 from online at http://www.ich.org/products/guidelines/safety/safety-single/article/safety-pharmacology-studies-for-human-pharmaceuticals.html.

41. International Conference of Harmonisation (ICH). S8 Immunotoxicity Studies for Human Pharmaceuticals. Septemer 2005. Last downloaded April 10, 2013 from online at http://www.ich.org/products/guidelines/safety/safety-single/article/immunotoxicity-studies-for-human-pharmaceuticals.html.

42. Code of Federal Regulations Title 21 Food and Drug Administration Part 210 and 211. Current Good Manufacturing Practices in Manufacturing, Processing, Packaging and Holding of Drugs. Last downloaded April 10, 2013 from online at  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=210 and  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=211.