Complementary and Alternative Medicines (CAM) and Traditional Medicinal Products (TMP)
according to the German Medicines Act (AMG), the particular therapeutic systems comprise
- anthroposophic medicine.
According to § 109a AMG, traditional medicinal products may also include medicinal products which do not belong to the so-called "particular therapeutic systems". They distinguish themselves from other medicinal products in that their efficacy is exclusively based on traditional use.
On the premise of pluralism in pharmacotherapy, the German Medicines Act explicitly postulates that the characteristics of the "particular therapeutic systems" are to be respected. For this reason, the legislator has established specific commissions (Commission C for anthroposophic medicinal products, Commission D for homeopathic medicinal products and Commission E for herbal medicinal products) to support the work of the BfArM by providing medical expertise in the respective therapeutic fields.
Management and scientific support of the above mentioned commissions and the Commission under § 109a (3) AMG for traditional medicinal products is incumbent on Division 5 of the BfArM.
Tasks of Division 4 "CAM and Traditional Medicinal Products"
Division 4 is in charge of the scientific evaluation of efficacy, safety and pharmaceutical quality of medicinal products appertaining to the "particular therapeutic systems" and of traditional medicinal products.
Responsibilities cover the preparation of medical and pharmaceutical assessments as well as the entire administrative project management including the issuing of marketing authorisation on the basis of successful licensing, simplified registration or review procedures.
Assessments are also prepared at the request of other divisions in variation or renewal procedures, in European licensing procedures for herbal medicinal products, in legal proceedings and questions of pharmacovigilance.
So-called core data are drawn up reflecting the current state of the art in pharmacotherapy serving to standardise patient information leaflets and information directed to health professionals.
Furthermore, scientific advice is provided prior to the start of licensing procedures at the request of pharmaceutical companies.
Division 4 develops scientific principles and guidelines relating to the evaluation of medicinal products of the particular therapeutic systems and traditional medicinal products. Members of Division 4 participate in national and international expert committees (e.g. Herbal Medicinal Products Committee (HMPC) of the European Medicines Agency (EMA), Homeopathic Medicinal Products Working Group (HMPWG) of the EU Heads of Agencies) and are thus essentially involved in transferring current scientific knowledge into European and WHO guidelines.
Statistics of Division "Licensing 4" on herbal, homeopathic, anthroposophic and traditional medicinal products with completed marketing authorisation or registration procedure which are available on the German market
Here you find the publications of Division 4 which are available in English.
- Prevention of drug-associated risks, Stage II Medicinal products prepared using plants of Aristolochiaceae of the Asarum genus (file size: 94 KB) as at 22 July 2010
- Medicinal products manufactured using plants of the Aristolochiaceae family with the genera Asarum, Aristolochia, Saruma and Thottea: Prevention of drug-associated risks, Stage II (file size: 93 KB) as at 07 December 2009
- Stability testing for medicinal products prepared in accordance with homoeopathic manufacturing procedures (file size: 42 KB)
Recommendations on how to use the”Guideline on Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products“ (CPMP/QWP/122/02, rev 1) as at 23 June 2006
- Criteria for Scientific Material in Support of Clinical Indications in Homeopathy (file size: 56 KB)
as at 09 October 2002
- Notice on the marketing authorization and registration of medicinal products (Recommendations for the planning and implementation of observational studies) of 12 November 1998 - (unofficial translation) (file size: 124 KB) - (unofficial translation) as at 12 November 1998
Please refer to the German version for full information.