Herbal and Homoeopathic Medicinal Products

Applications for marketing authorisation or registration of herbal and homoeopathic medicinal products should be as unbureaucratic and easy to handle as possible for manufacturers. At the level of the EU, harmonised criteria for the assessment of safety and efficacy of the products are an integral part of this concept.

In 2016, non-prescription herbal and homoeopathic medicinal products – from self-medication and upon medical prescription – generated a turnover of approximately EUR 2 billion in German pharmacies. This corresponds to about 31 percent of the total pharmacy turnover from non-prescription medicinal products.

In contrast to chemically defined medicinal products, herbal medicinal products contain pharmaceutically processed preparations of herbal drugs. Homoeopathic medicinal products can be of herbal, animal, mineral, chemical or human origin.

In Germany, herbal medicinal products must pass several control instances within the Federal Institute for Drugs and Medical Devices (BfArM) before they can be dispensed to patients in pharmacies. The manufacturers must submit documentation of the production and high quality standards of the medicinal product. Safety and efficacy must likewise be proven by bibliographic data or nvestigations by the manufacturer.

The herbal sector is mostly regulated at the EU level

The Herbal Medicinal Products Committee (HMPC) is situated at the ʻEuropean Medicines Agency’ (EMA). Since 2004 it has produced almost 150 assessments of single herbal drugs and preparations thereof in the form of monographs. The multitude of monographs covers a broad spectrum of therapeutic areas. In addition, the HMPC assumes responsibility for a multitude of guidelines for the assessment of the quality, safety and efficacy of herbal medicinal products. Such harmonised assessment criteria contribute to the facilitation of applications for marketing authorisations of herbal medicinal products with an acknowledged medicinal use and of the registration of traditional herbal medicinal products. Notably, older clinical data should be eligible as evidence of “well-established medicinal use”. The same applies to the use of herbal medicinal products in children. Within safety evaluations of the HMPC, especially for those herbal medicinal products which have already been marketed for a long time, it should be thoroughly balanced to what extent toxicological worstcase calculations with reference to single constituents are appropriate, as the preparations are complex mixtures of many substances.

Assessment of product-related claims needed

Herbals, including traditional herbal medicinal products, which have always been obliged to undergo an official marketing authorisation or registration procedure, must be preserved as a part of the treasure of medicinal products. This deserves special attention as European authorities still fail to implement the European health claims regulation for food supplements with herbal ingredients. Furthermore, herbal medicinal products and food supplements often bear similar product claims. The basic requirements of the European regulation concerning the scientific proof of health claims for food supplements are also appropriate for herbal ingredients. Only this warrants that the consumer obtains products with scientifically evaluated health claims.

Pharmacovigilance and variations: Taking particularities into account

Reasonable implementation of the European legal framework must take the particularities of herbal and homoeopathic medicinal products into account. This applies for example to the pharmacovigilance rules. Reports on adverse events for herbal and homoeopathic medicinal products are relatively rare. Likewise, it should be possible to perform variations including their approval procedures without great bureaucratic expenditure. In the case of complex natural substances, variations relating to analytical procedures are quite frequent and mostly without any safety relevance. Streamlining of the dossier for herbal and homoeopathic medicinal products might be a further measure for de-bureaucratization.

Alleviations for homoeopathic medicinal products with indications

So far, only very few Member States offer the opportunity to obtain a marketing authorisation with specified indications for a homoeopathic medicinal product. Increased use of this legal option of the EU would be desirable. It would facilitate mutual recognition of marketing authorisations for herbal and homoeopathic medicinal products with therapeutic indications. In this context, bibliographic data should also find more acceptance in marketing authorisation procedures for homoeopathic medicines.

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