Based on the amendment and Supplemental Regulation of Approval of New TCM Drugs implemented in 1992 [The approval of new pharmaceuticals (concerning the revision and the additional regulations on the sections on Chinese Traditional Medicine) implemented on 1 September 1992. Ministry of Health of the People’s Republic of China], new TCM drugs are classified under…
Herbal medicines in China are normally considered as medicinal products with special requirements for marketing that include quality dossiers, safety and efficacy evaluation, special labelling etc. The Drug Administration Law of the People’s Republic of China enacted in 1984 encourages the state to develop both modern and traditional drugs and the state protects the resources…
The market TCM has a long history of use of more than 4,000 years. Discovery of medicinal materials in ancient times was closely related to the life and the labour of people and their natural conditions of living. People found that many natural materials could be used to treat diseases, and great experience in this…
According to the law dietary supplement is considered to be food which does not need pre-market approval by the FDA, and not as a food additive which needs a pre-market approval by the authority. A statement on the label of a dietary supplement is allowed if a benefit is claimed related to a classical nutrient…
The market The use of herbal medicines in the United States is less widespread than in the majority of developed nations as wider distribution through pharmacies is difficult because no medical claims may be made and consumers are dependent on advice from pharmacists who, in majority of cases, have little knowledge about medicinal herbs. Also…
Criteria for registration and requirements for marketing authorizations for herbal remedies are as set out by European Directives and guidelines, such as the Note for Guidance on Quality of Herbal Remedies, the European Pharmacopoeia, and national guidelines and directives such as the guidelines for testing of drugs following section 26 of the Medicines Act. While…
In Germany, issues surrounding quality control and standardization of herbal products are less of a concern than elsewhere because ethical botanical manufacturers use the same high-quality production standards found in the synthetic drug industry. However in terms of legal status, herbal medicines are fully considered as medicines according to the Second Medicines Act of 1978 which…
The market Herbal medicine sales is growing in Germany and herbal remedies represent an important share of the German pharmaceutical market. According to an Institut fur Medizinische Statistik (IMS) report, presented during an ESCOP Symposium in Brussels in October 1990, the German herbal medicines market was worth US $1.7 billion in 1989, which was equal…
Furthermore in order to provide a specific framework for the registration of herbs and botanical preparations, a concept of review involving ‘Standardized Drug Monographs’ (SDM) has been proposed to facilitate registration of those drugs containing herbs that meet requirements of the monographs. Products making reference to such an SDM would require less individual premarket scrutiny…
The market Over the last decade there is a reported increase in the sale and use of herbs in Canada. In North America herbal remedies constitute a $2-billion-a-year industry that is growing at a pace of 15% annually. Legal status Herbal products were generally regulated as foods or drugs under the Food and Drugs Act…