The revision, which comes 10 years after the first guideline was released, looks to update the current standards based on advances over the last 10 years, as well as because of newly established practices and legal interpretations, EMA says.
“Developments and details in the assessment methodology have so far been mainly reflected in template revisions (such as Assessment report template), but also other documents such as the public statement 44 EMA/HMPC/473587/2011,” EMA noted.
In addition to the alignment with the other documents, EMA says the revision is aimed at improving the clarity and transparency by shortening some sections or providing more detail on some aspects of the assessment process, e.g. with regard to specific population groups. The guidance includes information on monographs for “well-established” herbal medicinal products and “traditional” herbal substances. For the traditional products, EMA calls for evidence of widespread, long-standing use without significant safety problems. “Deficiencies in available information must be clearly identified. If a traditional herbal medicinal product had long fallen into disuse, this might of itself raise questions as to whether this was due to safety concerns,” the guidance says.
In terms of therapeutic indications, EMA says claims such as “radical scavenger” and/or “antioxidant” are not considered appropriate. Furthermore, claims relating to clinical parameters such as the cholesterol level, blood pressure, immune status etc. require robust scientific data and are not considered appropriate by EMA.
“The therapeutic indication for a traditional herbal medicinal product should be given in the following way: ‘Traditional herbal medicinal product used for... The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.’” Indications that are too general and might be considered misleading are not acceptable, EMA says, noting the example of “promotion of good health,” or “to give general strength.”
Therapeutic indications solely based on pharmacological actions/effects traditionally attributed to the herbal substance/preparation (e.g. diuretic, analgesic or spasmolytic) also should not be used. And for both well-established and traditional herbal medicinal products, an assessment must address the situation of special patient populations, including children and pregnant/lactating women.
“A well-documented, consistent and long-standing use over at least 30/15 years will provide the basis for acceptance of an indication. An indication ‘exclusively based upon long-standing use’ may be plausible, even if no supporting scientific data are available. Evidence on the consistent use should include a well-defined posology (for specific age groups if available), administration form and indication,” EMA says. “If a traditional herbal medicinal product has long fallen into disuse, this might indicate that in practice the efficacy of the traditional herbal medicinal product is not plausible.”
Guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs for well-established and traditional herbal medicinal products