EMA: Final Guideline on Quality of Herbal Products

On 12 May 2022, the EMA published the final guideline on quality of herbal medicinal products/traditional herbal medicinal products. The Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency (EMA) originally started working on the revision of the guideline in 2015. Revision 3 which now represents the final guidance was adopted in January 2022.

The third revision considers new and revised guidelines, questions and answers and the Ph. Eur. revised general monograph “Herbal Drug Extracts”. It covers general quality aspects of herbal medicinal products (HMPs) for human and veterinary use as well as traditional herbal medicinal products (THMPs) for human use and newly includes further quality data requirements. It is adjusted and aligned

• 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 for control of herbal substances and preparations
• with Regulation (EU) 2019/6 for veterinary medicinal products
• and the Guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin (currently under consultation).

It comes along with the new requirements

• of a comprehensive specification for each herbal substance with information on the site of cultivation/collection, the time of harvesting and stages of growth, treatment during growth with pesticides etc., and drying and storage conditions and the origin to be stated at least on country level,
• an adequate assurance system, and
• for a written confirmation of GACP compliance which should be provided by the supplier of the herbal substance or the manufacturer of the active substance or the HMP.

If a monograph for a herbal substance exists in the European Pharmacopoeia (Ph. Eur.) or another Pharmacopoeia, the herbal substance must be in accordance with this monograph.

In general, herbal substances must be tested, unless otherwise justified, for microbiological quality, mycotoxins (aflatoxins, ochratoxin A), residues of pesticides and fumigation agents, heavy metals and likely contaminants (including heavy metals not mentioned in the monograph “Herbal drugs” of the Ph. Eur. and contaminants present in the specific environment), foreign matter and adulterants, etc.

Descriptions of the analytical procedures must be submitted, together with the limits applied.

The control tests on the finished product should allow the qualitative and quantitative determination of the active substance(s) as well as the determination of characteristic properties of the dosage form and the entire finished product including packaging characteristics. Chromatographic fingerprinting should be used, based on appropriate chromatographic methods. A specification should be provided including tests for all relevant parameters.

Source:

EMA: Guideline on quality of herbal medicinal products/traditional herbal medicinal products