Submitting a Monograph
Guidelines for Clinical Verification
Approved July 2020
3. Investigational Homeopathic Medicinal Product (IHMP)
In the development of these guidelines, various references were consulted including those standards that have been established by the Homeopathic Pharmacopeia Convention of the United States (HPCUS), the United States Food and Drug Administration (FDA), the International Conference for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) , the Homeopathic Medicinal Product Working Group (HMPWG) of the European Union Heads of Medicine Agency (HMA), and the EU-Notice to Applicants (NTA) guidance on homeopathic drug manufacture. Monograph sponsors are directed to the relevant sections of these guidance documents to ensure compliance with manufacturing standards for the United States and other countries where the IHMP may be manufactured and potentially marketed.
For monograph submissions, Good Manufacturing Practices (GMP), as defined in the HPUS, must be followed throughout the production process for manufacture of the IHMP.
- IHMP Manufacturer Information
Name
Address
Contact name
A means of contact
- Identity of IHMP
Sufficient information to identify the unique medicinal substance used in the manufacture of the IHMP must be provided.
Name of the substance including any scientific nomenclature, common name, and synonyms commonly used are to be included.
- IHMP Manufacturing Process
The sponsor must provide a statement confirming that the IHMP was manufactured in a manner consistent with Good Manufacturing Practices and in accordance with the HPUS.
- Toxicology
Unless previously submitted to the HPUS, the sponsor must provide a summary of the available toxicology to include the following:
a) A summary of known toxic effects of the IHMP
b) References to source information on toxic effects, and
c) If submitted previously, reference shall be made to the monograph submission document(s) title(s) and date(s)
- Proving Data on the IHMP
Reference to all available provings of the IHMP shall be provided, including all relevant primary and secondary publications and any monograph submission(s) as appropriate.
- Prior Clinical Information
Sponsors shall provide a summary of any available clinical information on the IHMP or state “not found” if no such information has been identified.
If available, the following shall be included:
d) A summary of any existing clinical case data on the IHMP that is not part of newly acquired data for monograph submission (may include data derived from the use of homeopathic or non-homeopathic forms of the IHMP)
e) A summary of published research on the IHMP (include data from use of homeopathically prepared or other forms)
A summary of any available repertory data on the IHMP is recommended to be included in the monograph submission.
- Existing Safety Data
Sponsors shall provide all available clinical safety data on the IHMP. This shall include a literature search beginning with the first date of IHMP manufacture or use.
Sponsors must provide a report of any pertinent pharmacovigilance data from manufacturer(s) of the IHMP.
Sponsors shall provide all available clinical safety data on the IHMP. This shall include a literature search beginning with the first date of IHMP manufacture or use.
Sponsors must provide a report of any pertinent pharmacovigilance data from manufacturer(s) of the IHMP.
(1) International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). ICH Guidelines. https://www.ich.org/page/ich-guidelines. Accessed September 09, 2020.