Herbal medicinal products: scientific guidelines

The European Medicines Agency's scientific guidelines on herbal medicinal products help medicine developers prepare marketing-authorisation applications for human and veterinary medicines.

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

Quality guidelines

• Declaration of herbal substances and herbal preparations in herbal medicinal products/traditional herbal medicinal products
• Good agricultural and collection practice for starting materials of herbal origin
• Quality of combination herbal medicinal products/traditional herbal medicinal products
• Quality of herbal medicinal products/traditional herbal medicinal products
• Specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products

Quality questions and answers

• Questions and answers on quality of herbal medicinal products/traditional herbal medicinal products

Quality reflection papers

• Level of purification of extracts to be considered as herbal preparations
• Markers used for quantitative and qualitative analysis of herbal medicinal products and traditional herbal medicinal products
• Microbiological aspects of herbal medicinal products and traditional herbal medicinal products
• Quality of essential oils as active substances in herbal medicinal products/traditional herbal medicinal products
• Stability testing of herbal medicinal products and traditional herbal medicinal products
• Use of fumigants
• Use of recovered/recycled solvents in the manufacture of herbal preparations for use in herbal medicinal products/traditional herbal medicinal products

Quality concept papers

• Development of a reflection paper on modern manufacturing techniques used for herbal preparations
• Development of a reflection paper on new analytical methods/technologies in the quality control of herbal medicinal products
• Development of a guideline on preparation of herbal teas
• Non-pharmacopoeial reference standards for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products

Non-clinical guidelines

• Assessment of genotoxicity of herbal substances/preparations
• Non-clinical documentation in applications for marketing authorisation / registration of well-established and traditional herbal medicinal products
• Selection of test materials for genotoxicity testing for traditional herbal medicinal products/herbal medicinal products

Clinical guidelines

• Assessment of clinical safety and efficacy in the preparation of EU herbal monographs for well-established and traditional herbal medicinal products
• Clinical assessment of fixed combinations of herbal substances/herbal preparations

Clinical reflection papers

• Adaptogenic concept
• Necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population

Safety of herbal substances/products public statements

• Allergenic potency of herbal medicinal products containing soya or peanut protein
• Capsicum/capsaicin containing herbal medicinal products
• Chamomilla containing herbal medicinal products
• Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) including recommendations regarding contamination of herbal medicinal products with PAs
• CPMP list of herbal drugs with serious risks, dated 1992
• Environmental risk assessment of herbal medicinal products
• Herbal medicinal products containing cimicifugae racemosae rhizoma - serious hepatic reactions
• Risks associated with the use of herbal products containing Aristolochia species
• Use of herbal medicinal products containing asarone
• Use of herbal medicinal products containing estragole
• Use of herbal medicinal products containing methyleugenol
• Use of herbal medicinal products containing pulegone and menthofuran
• Use of herbal medicinal products containing thujone
• Use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs)

The HMPC also publishes public statements in case an individual herbal substance assessments did not lead to the establishment of an EU herbal monograph. They are available in the Find medicine search.

Safety of herbal substances/products reflection papers

• Ethanol content in herbal medicinal products and traditional herbal medicinal products used in children
• Polycyclic Aromatic Hydrocarbons in herbal medicinal products/traditional herbal medicinal products
• Risks associated with furocoumarins contained in preparations of Angelica archangelica L.