20/21 September 2022
As previously announced, the European Medicines Agency (EMA) published the final guidelines (Revision 3) on quality and specifications for herbal medicinal products (HMPs). Amongst others, a written GACP confirmation for the herbal substance should be provided. In addition, EMA´s HMPC recently published a concept paper on the revision of the GACP guideline. The deadline for comments is 1 June 2022.
The Quality Guideline contains under section 5.1.1. Control of herbal substances the following provisions (amongst others):
In general, herbal substances must be tested, unless otherwise justified, for microbiological quality, mycotoxins (aflatoxins, ochratoxin A), pesticide residues and fumigation agents, heavy metals and likely contaminants (including heavy metals not mentioned in the Ph. Eur. monograph “Herbal drugs” and contaminants present in the specific environment), foreign matter and adulterants, etc.
The tests on the final medicinal product should include (amongst others):
Interestingly, for elemental impurities, the principles of ICH Q3D should be applied for the final HMP (HMPs are usually out of scope of ICH Q3D). It is the responsibility of the applicant to justify at which stage testing of impurities takes place (i.e. herbal drug, herbal drug preparation (e.g. extract), final HMP). In any case, the chosen acceptance criteria should be justified and the controls to be applied should take into account current intake limits and dosage of the HMP.
More detailed information is provided in the EMA Guidelines on quality of herbal medicinal products/traditional herbal medicinal products and on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products.