**7. National policies of herbal medicine**

A national policy on herbal medicine may include the following: a defining role of herbal medicine in the health care system, provision for the necessary regulations and laws, contemplation of intellectual property concerns [22]. National policies vary from country to country regarding herbal medicine. Herbal medicines are classified as either prescription or non-prescription medicines. The Working Party on Natural and Nutritional Supplements was established by the Australian Parliament to evaluate the safety, efficacy, quality and labeling of herbal products (Therapeutic Good Act, 1990). The act states "that traditional claims for herbal remedies be allowed, providing general advertising requirements are complied with and providing such claims are justified by literature references" [11]. Herbal medicine in Canada must meet the terms of the National Health Products Regulations. In accordance to these regulations, a product license is required for all herbal products to be sold in Canada. The recommended use, potency, comprehensive information on the medicinal constituents, source and nonmedicinal constituents need to be provided in order for a license to be granted. The companies that manufacture, pack, label and import herbal medicine also need a site license [3].

The Dietary Supplement Health and Education Act (DSHEA) of 1994, states that any herb, natural and botanical concentrate, constituent and metabolite of extract, is categorized as a dietary supplement. These supplementations do not need any sanction from the FDA. Herbal medicine which is categorized as dietary supplements under DSHEA, are alleged to be safe and the FDA does not have the authority to require them to be approved for efficacy and safety before they enter the market. However, manufacturers of these herbal products are required to provide purity and identification standards, and confirm that claims made concerning their products are precise [39, 44].

In Chile the Unidad de Medicina Tradicional was established in 1992, with the aim of incorporating herbal medicine with established efficacy into health programs (Law No. 19.253, October 1993). Directive No. 435/81 defines herbal drugs with therapeutic proposed claims and/or dosage recommendations as being medications, restricted from being sold in drugstores and pharmacies. Registration for marketing authorization is required for herbal products. These products are lawfully distinguished as follows: (1) drugs intended to alleviate, cure or prevent disease; (2) food products with therapeutic properties and for medicinal use, and (3) food products with nutritious purposes [11].

**9. Future prospects of herbal medicine**

indorse high quality research [10].

**10. Conclusion**

**Author details**

**References**

Pietermaritzburg, South Africa

In the past decade, about 121 pharmaceutical products have been formulated based on herbal medicine knowledge [42]. According to literature at least 25% of modern medicines are derived from plants, such as aspirin, picrotoxin and numerous others are synthetic analogues built on prototype compounds isolated from plants [48]. Because of the increase in the acceptance of plant derived drugs, the use of plants in medicine as a source of therapeutic agents will expand rapidly in the future [42]. This has extremely increased international trade of herbal medicine, attracting a number of pharmaceutical companies, including the multinationals [11]. The interest of WHO by documenting the use of medicinal plants used by ethnic groups, has increased scientific validation of the use of these plants. This will make people better informed concerning the effectiveness and safety of the treatment [21]. The regulation of herbs has assisted in improving herbal products, however additional changes need to be applied to advance and

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The use of herbal medicine is not restricted to developing countries. Over the years, there has been an escalating interest in the use of herbal medicine worldwide. This has greatly expanded the demand for plant products, since herbal medicine has an advantage of being inexpensive with minimal side effects compared to synthetic medicines. The growth of the herbal drug market has attracted pharmaceutical companies which in turn have driven scientific validation and clinical studies on herbal medicines. Thus far, few programs have been established to study the safety and efficacy of herbal medicines as originally proposed by the WHO Guidelines for the assessment of herbal medicines. These guidelines have been helpful in establishing the role of herbal medicine in the health care industry. However, the data to provide a precise assessment on the safety, quality and efficacy of herbal medicine is inad-

equate generating concerns regarding the use of herbal products.

Department of Biochemistry, School of Life Science, University of KwaZulu-Natal,

[1] Kunle OF, Egharevba HO, Ahmadu PO. Standardization of herbal medicines –A review. Journal of Biodiversity and Conservation. 2012;**4**(3):101-112. DOI: 10.5897/IJBC11.163

Nontokozo Z. Msomi and Mthokozisi B.C. Simelane\*

\*Address all correspondence to: simelanem2@ukzn.ac.za

In Europe, the European Directive 2004/24/EC released in 2004 by the European Parliament and by the Council of Europe provides the guidelines for the use of herbal medicines. The guidelines state that for herbal medicine to be released in the market, it needs authorization from the national regulatory authorities of each country in Europe and the herbal products must have a standard level of efficacy and safety. The registration of herbal products from outside the European Union (EU) require substantial evidence of their medicinal use, at most a period of 15 years within EU and 15 years elsewhere [3]. In Germany, more than 300 monographs on medicinal plants have been regulatory evaluated, and in France more than 200 herbs have been recorded as acceptable ingredients of herbal medicine [4].

The widespread use of herbal medicine in Brazil is favored by two present public policies i.e. the National Policy on Integrative and Complementary Practices in the Public Health System (PNPIC) and the National Policy on Medicinal Plants and Herbal Medicines (PNPMF), through the Law 971/2006 and the Declaration 5813/2006, respectively. Currently, 382 herbal medicines are registered in Brazil, 357 of these are single medicines and the other 25 are composed of more than one medicinal plant [45].
