Traditional Chinese herbal medicine in European Union: State of art, challenges, and future perspectives focusing on Italian market (2025)

Abstract

Traditional Chinese herbal medicine (TCM) has been used in China for thousands of years as an integral part of the healthcare system.The use of botanical products deriving from plants from TCM has become very spread and rooted in European Union (EU), generating a manufacturing industry of pronounced size, in particular the segment of food supplements, but recently also medical devices and cosmetics based on plants from TCM, especially in Italy. Only seven Herbal Medicinal Products (HMP) based on plants from TCM are present in EU besides more than 100 monographs on TCM plants are present in the European Pharmacopoeia. Indeed, the number of herbal monographs of European Medicine Agency (EMA) which report the main data on safety and efficacy of medicinal plants from TCM are very limited and this could be a reason for the limited number of HMP based on herbal drugs used in TCM. It is clear that those botanicals based on TCM but not classified as HMP can represent a sort of “borderline” products. Very likely, they are present on the European market because of the simpler authorization when compared with HMP. Some examples of these categories (food supplements and medical devices) containing plants from TCM and marketed in Italy are reported in this review. Consequently, it is urgent the need to clarify their categorization, also fundamental for the consumer protection. It is imperative the establishment of EU quality standards and official registration for Chinese herbal medicinal products, even if they are marketed as food supplements, medicinal devices or cosmetics because the international quality standards International Organization for Standardization Technical Committee 249-Traditional Chinese Medicine (ISO/TC249) can harmonize the quality control and promote the trading internationally. Governmental organizations together with companies producing TCM should work together to accelerate the legislation of laws pertaining to TCM, and generate an environment where TCM does not just continue to exist but truly develop.

1. Introduction

Traditional Chinese medicine (TCM) has been used in China for thousands of years as an integral part of the healthcare system and nowadays TCM is becoming one of the fastest growing industries. According to Cognitive Market Research, the market value was calculated as USD 219642.2 million in 2024 and projected to expand at a compound annual growth rate (CAGR) of 6.5% from 2024 to 2031. European Union (EU) accounted for a share of over 30% of the global market size of USD 65892.66 million. France is the first country of the EU Market (ca. 22%), followed by Italy and United Kingdom with a similar market share (18%). Germany and Sweden market segment is about 13%. All the other countries have a percentage lower than 9%. The European market for traditional Chinese medicine (TCM) is expanding and becoming more frequently accepted and widely acknowledged for health and well-being products (Gore, 2024).

If we trace the discovery of TCM, it is closely related to the process of searching for food by the ancient man, at least since the documented story of the farmer god Shen Nong tasting all kinds of plants during the Eastern Han Dynasty (25–220 AD). Through the repeated accumulation of previous generations, from unconscious accidental experience to conscious experimentation and observation, the initial knowledge of medicinal use has been gradually formed. Thus, many TCM herbs such as Dioscoreae Rhizoma, Lycii Fructus, Jujubae Fructus, have been characterized by the homology of medicine and food, being used as both medicine and food, and consequently, these plants are also available as foodstuff (Tan et al., 2017).

The European market of medicinal plants and their derivatives are varied with substantial differences in the classifications of products (Bilia, 2015). Categorization is linked to the products’ presentation, based on proper legal frame, which is common for all the European countries. Hence, medicines, food supplements (FS), cosmetics, and medical devices (MD) represent the market segments of botanical products (). According to the regulatory requirements, proper labelling of these botanical products plays crucial role in retaining the classification throughout the registration process. Moreover, medicines and MD have medicinal claims, while cosmetics and food supplements should have only health claims (Bilia et al., 2021). The principal aim of this review is the analysis of the European market of TCM medicinal plants and their preparations. Nowadays the European market display different categories of products containing TCM ingredients, in addition to Herbal Medicinal Products (HMP), are now available FS, MD and cosmetics according to specific European regulations. Consequently, the same botanicals preparations can assume different indications with medicinal or health claims and diverse legal market positions.

Search was based on the websites of EMA, of EFSA, of European commission, of EDQM, and the Medicines, MD, Cosmetic and Food Agencies websites of the EU countries up to January 2024. In addition, a survey of the marketed botanical products in Europe and based on medicinal plants from the TCM was directly analyzed by the authors and by PubMed and ScienceDirect.

2. Legal status of HMP in EU

Medicines based on medicinal plants, or their preparations are defined legally as HMP and include both prescription-only medicines, medicines over the counter (self medication), and medicines advised by the pharmacist for minor diseases, or trivial symptoms do not need of a medical prescription. Hence, this classification is based on various factors including the risk associated with its use, how it is to be taken (parental, oral or external forms of administration), the potential for misuse, or the need of a medical doctor to make the clinical diagnosis and manage the therapy. In EU, the status of the HMP is in the Pharmacy (). HMP contain Herbal Drug Preparations (HDP) or Herbal Drugs (HD), both defined legally by the European Pharmacopoeia (Eur. Phar.). HDs represent the part of the medicinal plant containing the active constituents and it is well defined by the botanical name according to the scientific binomial system (genus, species, and author). The HD is denominated Herbal Substance by the European Medicines Agency (EMA). The Eur. Phar. also states the definition of Herbal Drug Preparation (HDP) which is represented by “comminute (powdered or cut) HD, extracts, tinctures, essential oils, expressed juices and processed exudates” (Herbal Drugs, 2024, Herbal Drug Preparations, 2024).

Therefore, HMP are medicinal products where the active ingredient consists exclusively of HD or HDP, as defined in Directive 2001/83/EC (formerly 65/65/EC, and amended by Directive 2004/27/EC) (European Commission, 2001) on the Community code relating to medicinal products for human use (“Directive on human medicinal products”) and Directive 2001/82/EC on the Community code relating to veterinary medicinal products (“Directive on veterinary medicinal products”). According to the legislation, any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting, or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medicinal diagnosis can be a medicine.

As for the synthetic chemical drugs, the marketing of HMP requires an ad hoc authorization based on quality, safety and efficacy. The , (EDQM) has the role to promote and protect human and animal health by establishing and providing official standards for the manufacture and quality control of medicines (Kroes, 2014). In particular, the Eur. Phar. monographs cover the quality requirements, while main data on safety and efficacy of medicinal plants are described by the monographs of the EMA (Bilia, 2014). EMA monographs are freely available online (European Medicine Agency, 2024) and are denominated EU herbal monographs (formerly known as Community herbal monographs). They are about two hundreds and reflect the scientific opinion on safety and efficacy data about an herbal substance and its preparations intended for medicinal use of the Committee on Herbal Medicinal Products (HMPC). These monographs include non-clinical and clinical data, in addition to documented long-standing use and experience in the EU. The monographs represent an overview of what the herbal product is used for; who the herbal product is intended for; safety information such as information regarding undesirable effects and interactions with other medicines (Peschel, 2014). A list of the monographs available on the EMA website is reported in Table 1.

The EU herbal monographs are divided into sections: a traditional use (TU) and a well-established use (WEU), which are evaluated according to the requirements for simplified registration and marketing authorization, respectively (Qu et al., 2018). In some cases (Table 1) the same HD has both WEU and TU monographs, according to different HDPs (generally different extracts obtained using diverse solvents and drug/extract ratios).

The traditional use is referred to a use of the product for at least 30years, including at least 15years within the EU, while the WEU is based on scientific literature establishing the medicinal use within the EU for at least ten years, with recognized efficacy and an acceptable level of safety, mostly based on bibliographic data. In both cases, monographs form the basis for the required individual medicinal product information such as the summary of product characteristics for the registration procedure, and mutual recognition and decentralized procedures are possible (Van Galen, 2014). If the medicinal plants do not fulfil with these characteristics, the HMP follow the regular registration procedures for the market authorization, according to European Directives 2004/27/EC (European Commission, 2004) and 2004/24/EC (European Union, 2004). Unambiguously, Traditional Herbal Medicinal Products (THMP) have a simplified registration (Article 16a (1) of Directive 2001/83/EC, European Commission, 2001). Being the status of THMP based on bibliographic data and long-standing use, consequently, no clinical trials on safety and efficacy are required. Therefore, THMP can be used without the supervision of a medical practitioner and are administered only by oral, topical, nasal, and rectal routes. The marketing authorization of Well-Established Herbal Medicinal Products (WE-HMP) is according to the Article 10a of Directive 2001/83/EC. The status of WE-HMP is characterized by their use within the EU for at least ten years in the form of medicinal products, and a recognized efficacy and an acceptable level of safety resulting from the scientific literature. Consequently, further preclinical or clinical studies may be waived (European Medicine Agency, 2024).

The EU herbal monographs give companies and national competent authorities a clear reference point when preparing or assessing an application for marketing authorization or registration of herbal medicinal products in EU Member States. National competent authorities evaluate marketing applications but they are not not obliged to accept the classification of TU or WEU as reported in the monograph and it is possible that a Member State, with a due justification, will choose not to adhere to the monograph, evaluating the product as TU instead of WEU as reported in the specific monograph (European Medicine Agency, 2024).

3. Products based on TCM in European market

The Eur. Phar. has published more than 100 monographs of herbal drugs from TCM, elaborated principally (about 90) by the EDQM TCM expert group and by EDQM 13A expert group. A list of TCM monographs is reported in Table 2. The list includes the Latin and English titles, and Chinese names in pinyin (Names of Herbal Drugs in Traditional Chinese Medicines, 2024).

By contrast, the number of EMA monographs of plants from TCM is quite limited, based on our analysis (European Medicine Agency, 2024), so far that there are only 22 herbal monographs related to TCM. Consequently, the very limited number of HMP monographs based on TCM can represent a hurdle for TCM to entering EU market as traditional or well-established HMP.

In Table 3, the 22 single herbal substances reported in the EU monographs and in the Chinese Pharmacopoeia are listed. Twelve of these herbal substances are traditionally used (TU) for at least 30years, including at least 15years in the EU, six are reported as well-established use (WEU) herbal substances/preparations, which have at least 10years of medicinal use in EU, while four are stated both for TU and WEU.

Most of these herbal substances have indications for minor disorders, suitable for self-medication, including the common cold, gastrointestinal disorders, pain and inflammation, fatigue and weakness, etc. A few TU herbal substances/preparations are reported for the treatment of serious illnesses, e.g. Silybi mariani fructus indicated to support the liver function, Allii sativi bulbus recommended to prevent atherosclerosis. Nevertheless, both are limited to cases where a doctor has ruled out a serious condition or to aid in the prevention and treatment.

Remarkably, 44 EU herbal monographs are concerning medicinal plants belonging to the same genus but different species of plants also present in the Chinese Pharmacopoeia (2020 edition), as shown in Table 4.

TCM practice is characterized by medications based on Multi-herbal TCM products. Conversely, in EU there are a few Multi-herbal EU products. As reported in Table 5, only six combination herbal substances were included in published EU monographs. However, none of them has a TCM tradition (Qu et al., 2022).

HMP based on plants from TCM successfully registered in EU market are only seven and their marketing authorization is linked to the traditional status. In Table 6 the list of the registered TCM is reported: five of them are represented by preparations of single medicinal plants, namely Diao Xin Xue Kang, Danshen and Yufeng Ningxin marketed in Netherland, Phynova Joint & Muscle Pain Relief and Phynova Cold and Flu Relief, marketed in United Kingdom. Only two HMP were characterized by complex mixture of different TCM plants, one marketed in Germany, denominated YamatoGast and the other, Xiao Yao, marketed in Netherland. Quantitative composition, type of solvent of extraction, and corresponding product in Chinese Pharmacopoeia are reported in the publication by Xiong and coworkers (Xiong et al., 2022).

According to the directive 2004/24/EC, a upplementary regulation that established the simplified registration application for THMP all these preparations were marketed (Wiesner and Knöss, 2014, Wang et al., 2020, Wang et al., 2022).

Numerous other botanical products derived from TCM have entered the EU market as foods, food supplements or cosmetics (Qu et al., 2014). However, under these designations, these products are not monitored under EU pharmaceutical law. Sometimes they also declare therapeutic effects, without reliable information concerning rational dosage, specific conditions, and possible side effects, and they may pose a risk to the public health. In truth, according to Article 3 of 2001/83/EC (The European Parliament and the Council of the EU, 2004) “any medicinal product prepared in a pharmacy in accordance with a medical prescription for an individual patient, ‘commonly known as magistral formula’, is not covered by the Directive.” This leaves a space for registered pharmacies and TCM practitioners to make magistral preparations based on traditional Chinese herbal drugs in the market, of which the quality should fulfill the requirements of European Pharmacopoeia. In Germany, Italy and many other European countries, these magistral preparations can be prepared in registered pharmacies, while in other European states such practices are less common and considered to occupy a legal grey area. Meanwhile, there are no constraints regarding the supervision and regulation of herbalists in EU-level legislation. Most member states do not have official rules for TCM practitioners, or, at most, they provide regulations for acupuncturists (Xiong et al, 2022).

4. Other categories of products containing botanicals and their preparations in the European market

5. Italian market of preparations based on TCM: A paradigmatic example of EU countries

No HMP based on TCM are marketed in Italy. Italy is the second largest herbal medicine market in EU for products. Based on manufacture price in Italy the Market has an annual costs of €1.1 billion equivalent to 17% of the total European market in 2022 (Heinrich et al., 2023). By contrast, there is a wide market of the herbal drugs from TCM and other pre-formulated products. In particular, the Pharmacists but also the Herbalist (having a Bachelor's degree course in Herbal Sciences and Technologies) can mix medicinal plants (also those from TCM) and their derivatives, even extemporaneously. Consequently, medicinal plants from TCM can be present in Herbalist shop and Pharmacies. It is noteworthy that in many cases pharmacies can prepare pharmaceutical forms, mainly represented by capsules, containing granules and powdered dried extracts of single TCM HDs, which can be prepared according to master medical prescriptions personalized for single patients as “magistral” recipes. Obviously, only toxic, and poisonous plants whose use remains possible in a strictly medical-pharmaceutical field should be excluded from the mixing practice. In particular numerous dried extracts and an increasing number of granules are available on the Italian market, many of them do not appear in the list of Ph. Eur. monographs i.e. dried extracts of Spatholobus suberectus Dunn herb, Phellodendron chinense C. K. Schneid bark, Lysimachia christinae Hance herb. In addition, pre-packed products (herbal drugs, food supplements, cosmetics, medical devices) formulated with TCM plants can also be sold in pharmacies, para-pharmacies, supermarkets, and specialist shops. Among the pre-packed formulations present on the market, mostly of are represented by the FS, followed by cosmetics and MD. Mostly of the FS contain single HDP which are present in the list of the Ph. Eur. However, some plants are not present in the list of the Ph. Eur., including some of the most common plants such as Astragalus membranaceus Moench., and used in the market, in particular those from fungi such as Monascus purpureus Went, Ganoderma lucidum (Curtis) P. Karst., and Cordyceps sinensis (Berk.) Sacc.

Concerning FS, the Italian Ministry of Health has notified the list of botanicals (vegetable substances and preparations) allowed in food supplements shared with the health administrations of Belgium and France (Ministero della Salute, 2014). The list includes more than 1 000 plants and fungi, exhibiting the botanical name, family, synonym, part of the plant traditionally used/specific preparations, and notes. This list includes the botanical name of the plant species in alphabetical, the family, synonym, part of the plant traditionally used and specific preparations, and finally the notes. No data on indications are reported, but it can be considered as a starting point for a future European regulation.

In addition, in Italy is available another positive list of botanicals and their products that may be used in the manufacture of FS, published as annex 1 the Ministerial Decree of 10.8.2018 (Ministero della salute, 2018). More than 1200 plants are alphabetically listed and include the botanical name of the HD including the author, part(s) of the used HD (including indications), and the notes and restrictions. Additionally to this positive list, there is a list of botanicals banned from food (negative list) in which is reported the botanical name and part(s) of the plant material (about 400 banned plants).

An accurate analysis of the botanical FS based on TCM ingredients in the Italian market has evidenced the presence of products with and without the “ministerial code”, or more simply “minsan code”, which is the number that the Ministry of Health assigns to drug, medical device, medical-surgical device, parapharmaceutical, food supplements, and in general products related to health properties. In Table 7 a list of both kinds of products is reported indicating the TCM ingredients, pharmaceutical forms, and health claims. Dosage forms are represented by tablets, capsules, sachets (granulates), syrups and other liquid preparations.

From the analysis of the ingredients of FS having minsan code, product 5 contains Albizia julibrissin Durazz. bark, which is in the Italian list, but it has a warning “do not use in pregnancy”, which is not reported in the market product, in addition an ingredient is Trichosanthes kirilowii Maxim.) fruit without trichosantin, as reported in the Italian list. All the products contain plants in the BELFRIT or Italian list, with the exception of product 12 which contain some herbal drugs which are not present in the Italian list of plants admitted in FS or in the BELFRIT list Fritillaria cirrhosa D. Don, Adenophora tetraphylla Thunb, and Platycodon grandiflorum (Jacq.) A. DC. In addition, the last one should not be present in the preparation because it is present in the special list of plants not allowed as ingredients of the FS.

Concerning FS without the minsan code, products 2, 4, 5 and 7 contain plants which are not present in both the Italian list of plants admitted in FS and BELFRIT list. These plants are Platycladus orientalis (L.) Franco (product 2), Pyrola calliantha Andres herb, Drynaria fortunei J. Sm. rhizome, and Epimedium brevicorum Maxim leaf (product 4), Platycodon grandiflorum (Jacq.) A. DC. (product 5), Lilium lancifolium Thunb., Corydalis yanhusuo W. T. Wang, and Gallus gallus domesticus Brisson (product 7). It is notherworth that Platycodon grandiflorum (Jacq.) A. DC. (product 5), is reported in the Italian list of plants not permitted as ingredients of FS, while Gallus gallus domesticus Brisson (product 7) is from animal origin. According to the list of TCM raw materials that can be used as both food and medicine published by the National Health Commission of the People's Republic of China (National Health Commission of the People's Republic of China, 2002), there are some TCM which derived from animals, among others Zaocys dhumnades, Galli Gigerii Endothelium Corneum, mel. However, further evaluation and research are needed for exportation whether these materials can enter the European market.

Finally, cosmetics and MD can be also present on the market occasionally, but the number of these types of preparations reaching the Italian market is increasing and evolving within the last year. Mostly of the MD are preparations to be used for moxibustion (moxa rolls), but according to the new MD regulations, an increasing number of products are reported, especially for external use, as the two reported in Table 6. Concerning MD, product 2 contains Arnebia euchroma Royle, which is not reported in the BELFRIT and Italian list of permitted plants for FS, and it is present in the list of cosmetic ingredients. Concerning the two cosmetic products, all the ingredients were included in the list of cosmetic ingredients.

6. Conclusions and perspectives

It is widely recognized that the number of TCM products available on the markets reflect a great acceptance from the European population and their quality is required in all aspects of the production of Chinese herbal medicinal products (Wang et al., 2021). However, our study has evidenced a very limited number of HMP (only seven) based on TCM plants in EU besides the number of health products based on TCM plants market in EUis very high. Focusing on the Italian market, no HMP based on TCM plants are available, but numerous FS, MD and cosmetics are available. This trend has drawn the attention of competent Authorities to reconsider the actual European legislation of the different sectors of health products, for a simpler identification of the characteristics of the different types of products on the market. In many cases these health products are like HMPS and represent “borderline” products. Indeed, all the European countries have common regulations, but different approaches of the competent regulatory Authorities can give the opportunity to put on the EU market products with different classification even containing same ingredients, lacking the harmonization through EU. MD, FS and cosmetics can be placed on the market with simplified authorization if compared with HMP. Consequently, MD can compete with HMP because they can claim medical properties, FS could be in competition with orally used HMP, and cosmetics with HMP for topical use.

In EU there is a general need of establishment of the EU quality standards and official registration for Chinese herbal medicinal products, which should represent a must, even if they are marketed as FS, MD or cosmetics because the international quality standards ISO/TC249 can harmonize the quality control and promote the trading internationally.

In addition, TCM companies should be involved in this process, and they should be willing to finance research and services to adapt the UE market needs. Governmental organizations should assist in creating advancements to hasten the legislation of laws pertaining to TCM, employing severe administration of TCM products and services and assist to generate an environment where TCM does not just continue to exist but truly prosper (Cao et al., 2019).

CRediT authorship contribution statement

Anna Rita Bilia: Conceptualization, Methodology, Project administration, Writing – review & editing. Rebecca Ballerini: Data curation, Resources, Writing – original draft. Liping Qu: Data curation, Writing – original draft. Mei Wang: Methodology, Supervision, Writing – review & editing.

Declaration of competing interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Acknowledgments

The financial support provided by the MUR - Dipartimenti di Eccellenza 2023–2027 (No. DICUS 2.0) to the Department of Chemistry “Ugo Schiff” of the University of Florence is acknowledged. Mei Wang’s research is partially support by Dutch subsidy entitled: “Programma EFRO West-Nederland 2021-2027”.

References