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EMA publishes final guidelines on quality and specifications for herbal medicinal products

The European Medicines Agency (EMA) published the Guideline on quality of herbal medicinal products/traditional medicinal products (Revision 3) and Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products (Revision 3). In addition, EMA´s Committee on Herbal Medicinal Products (HPMC) published in March 2022 published Concept paper on the revision of the Guideline on Good agricultural and collection practice for starting materials of herbal origin, (EMA/HPMC/398706/2021). The deadline for comments is 1st of June 2022.

Guideline on quality of herbal medicinal products/traditional medicinal products intends to cover the general quality aspects of herbal medicinal products (HMPs) for human and veterinary use, including traditional herbal medicinal products (THMPs) for human use. It describes the special problems of HMPs and the differences to medicinal products containing chemically defined active substances. The third revision considers new and revised guidelines, Questions and answers and the Ph. Eur. revised general monograph “Herbal Drug Extracts” as well as experiences gained over the years with the application of the guideline. Further clarifications on quality data requirements are provided via improved wording, structure and reference to updated related guidelines as outlined in the concept paper EMA/HMPC/217631/2015.

Particular attention has been paid to adjustment with the in parallel revised “Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products”.

Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products applies to human and veterinary medicines and addresses specifications, i.e. those tests, procedures, and acceptance criteria used to assure the quality of the herbal substances/preparations and herbal medicinal products at release and during the shelf-life.

For elemental impurities, the principles of ICH Q3D should be applied for the final herbal medicinal products. It is the responsibility of the applicant to justify at which stage testing of impurities takes place (i.e. herbal drug, herbal drug preparation of final herbal medicinal products). In any case, the chosen acceptance criteria should be justified and the controls to be applied should consider current intake limits and dosage of the herbal medicinal product.