Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Zulassung und Handel von Produkten der traditionellen chinesischen Medizin (TCM) in der Schweiz und in Europa unter besonderer Berücksichtigung von Österreich und Deutschland ***

Dr. Katrin Jahn (Abschlußjahr: 2006)

Language: German

The aim of this thesis was to examine the trade in products of the traditional Chinese medicine in Europe more detailed. These “goods” are sold as raw materials, foodstuffs or medicinal products. Legally regarded each marketing form is subject to certain requirements. In addition the application of the traditional Chinese medicine requires special qualification and knowledge. For example, in contrast to China, in Europe TCM is no compulsory subject of the regular study of medicine [1]. Based on TCM, Europe is faced with many questions, both on the medical / therapeutical field and on the pharmaceutical / regulatory field. Fact is that the complementary medicine including the TCM is growing in popularity in the European population. Therefore an urgent need for action exists to clarify and to arrange all legal aspects of this development. By this thesis the present legal status is intended to be pointed out, both in Switzerland and in the European Union. In the Member States there is no scope for national special ways because European regulations and directives are either directly legally valid or have to be implemented into national law.

On the basis of the corresponding Swiss and European legislation three questions were comparatively examined:
  1. Which procedures of marketing authorization are possible for medicinal products of the traditional Chinese medicine?
  2. How is the importation of medicinal products from third countries laid down by law?
  3. Is it legally possible to sell substances, used in traditional Chinese medicine as medicinal products as food supplements as well?
Switzerland
 
1. In Switzerland the necessity has been recognized that the regulation of herbal and complementary medicinal products could only be realized on realistic conditions. Since autumn 2002 these conditions were elaborated by those groups being involved, representatives of the authority Swissmedic, complementary-medical physicians and therapists, the association of complementary medicinal products as well as the corresponding branch of industry under formation of two working groups (homeopathy / anthroposophy and Asian medicinal products). Finally, at the end of June 2006 the “Verordnung des Schweizerischen Heilmittelinstituts über die vereinfachte Zulassung von Komplementär- und Phytoarzneimitteln (Komplementär- und Phytoarzneimittelverordnung, KPAV)“ [14] has been passed. The ordinance came into force on 1 October 2006 [61].

Apart from the special definitions in Article 4 (Begriffe) the 3rd Chapter (Asiatische Arzneimittel) of the KPAV [14] is of special importance for the medicinal products of the traditional Chinese medicine. This Chapter is unique in the European legislation. In the legislation of other European countries these medicinal products are not specially considered. Asian medicinal products are laid down by law just in seven Articles (Art. 25 Art. 31) of the KPAV [14]. Traditional Asian medicinal products without therapeutic indication can be placed on the market by means of the simplified marketing authorization procedure or of the notification procedure (Art. 27 Art. 29). The documentation on the quality of Asian medicinal products is required. In the case of the notification procedure the documentation must be available on request. The “list TAS” (traditionelle asiatische Stoffe) is the basis for the notification procedure. Only substances of the traditional Chinese medicine are listed which are sufficiently documented in the scientific and pharmaceutical literature and which may be used by qualified persons (expert). Human and animal substances are not registered. Because of the requirements Asian medicinal products are generally not intended for OTC.
The requirements for Asian medicinal products with therapeutic indication are comparable with the EU- legislation [61].

 
2. In the 2nd Chapter of the HMG [12] the legal basis for importation is laid down. For sale the Swiss importer and marketing authorization holder needs a authorizations for the manufacture, the wholesale and the import. The Swiss importer takes the responsibility for the fact that abroad medicinal products are manufactured in accordance with Swiss GMP-requirements (Article 7 (1i) AMBV [17]). Additionally, according to Article 7 (3a) AMBV [17] the Swiss importer is responsible that each released batch corresponds to the specifications and the requirements of the marketing authorization. A special leaflet (Merkblatt: GMP-Konformität ausländischer Unternehmen [25]) informs about the proof of the GMP-conformity.

3. On 1 January 2006 the new Swiss food law [32] and different food ordinances came into force. In Switzerland food supplements belong to “Spezial-lebensmitteln” (special food) based on the particular “Verordnung des EDI über Speziallebensmittel” [36]. In principle, all substances in the field of foodstuffs are listed. If a substance does not appear on a list, it must be approved by the BAG before placing on the market. Apart from the composition, products are examined concerning safety, the purpose, advertising and labelling. Important is the required nutritional-physiological effect of substances belonging to special food. Only herbal substances of the TCM can be approved as food supplements if they serve this purpose. However, this use does not correspond to the traditional Chinese medicine.

Europe
 
1. In Europe the legal basis for marketing authorization of medicinal products is laid down in the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [45], meanwhile amended by the Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 relating to medicinal products for human use [46] and the Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004, as regards traditional medicinal products [47]. In principle three possibilities are available for the marketing authorization of herbal medicinal products in the European Union:
  • Application according to Article 8, Directive 2001/83/EC [45]
    (full application)
  • Bibliographic application (“well-established medicinal use”) according to Article 10a, Directive 2004/27/EC [46]
  • Simplified registration procedure (“traditional-use registration”) according to Article 16a 16i, Directive 2004/24/EC [47].

The term “traditional” is misleading if connected with traditional Chinese medicine or traditional Chinese substances. According to the spirit of the EU-law the term is not generally used but restricted to special European medicinal plants (see reasons for consideration of Directive 2004/24/EC [47]). Accordingly the “traditional- use registration” is only possible for these European plants. Article 16a (1a) of the Directive 2004/2/EC [47] is important because herbal medicinal products “have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment”. Consequently the use of these medicinal products is meant for self-medication in the sense of OTC. Thus, the intended application of the traditional medicinal products in the European Union clearly differs from that in Switzerland where differentiation is usual between traditional herbal medicinal products of Europe and other (Asian) countries.

Because Asian medicinal products are not expressly mentioned in the wording of the European law the procedures relevant to the marketing authorization of these products remain speculative. Surely, a full application is possible. Also the requirements of a bibliographic application can be fulfilled in many cases. The “list of herbal substances, preparations and combinations thereof” (according to Article 16f of [47]) for use in traditional herbal medicinal products is not yet established and the work on Community herbal monographs based on Article 16h [47] has started. For the next time no simplified marketing authorization procedures for herbal medicinal products of the traditional Chinese medicine are in prospect.

2. The importation of medicinal products from third countries is clearly laid down in different Articles (20, 40(3), 41, 46a, 48, 51(1) b, (2), (3), 54 65 and 118) of Directive 2001/83 [45]. An authorization is required for importation and manufacturers of medicinal products coming from third countries and does not differ from the fundamental provisions of Switzerland. Simplifications with regard to the acceptance of other certificates than PIC/S-certificates are not intended.

3. Directive 2002/46/EC [57] represents the legal European basis for food supplements. The term “Speziallebensmittel” (special food) is not used in the European legislation of foodstuffs. Specific rules for vitamins and minerals are laid down in this Directive [57]. According to the reasons for consideration (no 6) of [57] “There is a wide range of nutrients and other ingredients that might be present in food supplements including, but not limited to vitamins, minerals, amino acids, essential fatty acids, fibre and various plants and herbal extracts.” Special rules are not yet compiled for these substances. In principle they must have a nutritional or physiological effect. Surely, some plants used in the traditional Chinese medicine as medicinal products will be considered. Then, in accordance with the Directive [57] these plants are used for dietary purposes and not for medicinal purposes.

Pages: 46
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