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New HMPWG consultations – questions and answers on quality and first safe dilutions

15 Jan 2019

The Homeopathic Medicinal Products Working Group of the Heads of Medicines Agencies (HMPWG) has released three new documents for public consultation.

 The first two documents address draft questions and answers relating to quality:

  • Question 8: In case of stocks and dilutions, prepared according to Ph. Eur. monograph 2371, is a process validation to be performed?
    The HMPWG answer in the consultation document is that a manufacturing process described in the Ph. Eur. monograph 2371, Methods of preparation of homoeopathic stocks and potentisation, is not regarded validated but can be considered as a standard process. Information on validation of non-sterile active substances is not required in the dossier. However, it is important to demonstrate the reproducibility of the manufacturing process according to GMP requirements. Therefore, in the dossier a scheme of the manufacturing process should be provided.
  • Question 11: Are homeopathic medicinal products based on herbal substances/preparations out of scope of ICH Q3D (similar to herbal medicinal products)?
    HMPWG answers that guideline Q3D (Guideline for Elemental Impurities) applies to all homeopathic medicinal products for human use.
  • Question 12: What kind of data is expected for the risk assessment and control of elemental impurities in homeopathic medicinal product for human use?
    HMPWG answers that guideline Q3D describes how to assess and control elemental impurities in the drug product. Potential source of elemental impurities are active substances, excipients, manufacturing equipment and container closure systems. Regarding the active substance, the source or origin and the degree of dilution are to be considered. It is possible to group dosage forms with identical excipients and manufactured at the same production site. The summary of the risk assessment is to be provided in module 3.2.P.5.5 or 3.2.P.5.6 of the registration dossier.

The third document for consultation is the draft of the 5th list on First Safe Dilutions (FSD) containing 30 stocks. The consolidated Lists 1-4 were adopted and published in November.

ECHAMP members are invited to submit their comments to the office by 27th February.