Herbal medicinal products: scientific guidelines

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

Use the links below to find guidelines that are specifically related to herbal medicinal products:

• Quality
• Non-clinical
• Clinical
• Safety of herbal substances/products

If you have comments on a document which is open for consultation, use the.

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

Questions and answers

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

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 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

Concept papers

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 for herbal medicinal products in applications for marketing authorization

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 Community herbal monographs for well-established and of Community herbal monographs/entries to the Community list for traditional herbal medicinal products/substances/preparations

Clinical assessment of fixed combinations of herbal substances/herbal preparations

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

Contamination of herbal medicinal products/traditional herbal medicinal products with pyrrolizidine alkaloids

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.

Reflection papers

Ethanol content in herbal medicinal products and traditional herbal medicinal products used in children

Risks associated with furocoumarins contained in preparations of Angelica archangelica L.