Submitting a Monograph
Guidelines for Homeopathic Drug Provings
Approved April 2015
3. Investigational Proving Substance
In the development of these guidelines, various references were consulted including those standards that have been established by the Homeopathic Pharmacopeia of the United States (HPUS), 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 (EU) Heads of Medicine Agency, and the EU-Notice to Applicants (NTA) guidance on Homeopathic drug manufacture (1), (2).
For monograph submission, Good Manufacturing Practices (GMP) should be followed throughout the production process for manufacture of the Investigational Proving Substance (IPS) used in the Proving. Information specific to Provings regarding the IPS as described in the following guidelines should accompany the Provings Report (Appendix A).
- Investigational Proving Substance Manufacturer Information
A means of contact
- Identity of IPS
Sufficient information to identify the unique substance used in the IPS must be provided.
Name of the substance including any scientific nomenclature, common name, and synonyms commonly used are to be included.
- IPS Manufacturing Process
The sponsor must provide a statement confirming that the IPS was manufactured in a manner consistent with Good Manufacturing Practices and the process described in current HPUS guidelines.
The sponsor must provide a summary of the available toxicology to include the following:
a) The sponsor must provide a summary of known toxic effects of the IPS.
b) References to source information on toxic effects should be included.
- Prior Clinical Information
Sponsors are recommended to provide a summary of any available clinical information on the IPS. Such information may include:
a) A summary of clinical case reports for the use of IPS in homeopathic or other forms.
b) A summary of published research on the IPS in homeopathic or other forms.
c) A summary of publication reference information.
- Prior Proving of the IPS
If referenced, such Proving information should be made available to any HPCUS review committee upon request.
Any available prior Proving information on the IPS is recommended to be referenced in the current submission.
(1) Homeopathic Pharmacopeia of the United States, www.hpus.org
(2) Guidance on Module 3 of the Homeopathic Medicinal Products Dossier, Homeopathic Medicinal Product Working Group, Last downloaded April 01, 2012 from online at