National Policy on Traditional Medicine and Regulation of Herbal Medicines - Report of a WHO Global Survey
(2005; 168 pages) Voir le document au format PDF
Table des matières
Afficher le documentAcknowledgements
Afficher le documentExecutive summary
Afficher le documentAcronyms, abbreviations and definitions
Afficher le documentWHO Regions
Ouvrir ce répertoire et afficher son contenu1. Introduction
Ouvrir ce répertoire et afficher son contenu2. National policy on traditional medicine and complementary/alternative medicine
Fermer ce répertoire3. The regulatory situation of herbal medicines
Afficher le document3.1 Law or regulation on herbal medicines
Afficher le document3.2 Regulatory status of herbal medicines
Afficher le document3.3 Claims
Afficher le document3.4 Pharmacopoeias
Afficher le document3.5 Monographs on herbal medicines
Afficher le document3.6 Manufacture of herbal medicines
Afficher le document3.7 Safety and herbal medicines
Afficher le document3.8 Registration system for herbal medicines
Afficher le document3.9 Herbal medicines and the essential drug list
Afficher le document3.10 Post marketing surveillance of herbal medicines
Afficher le document3.11 The sale of herbal medicines
Afficher le document3.12 Annual market sales of herbal medicines
Ouvrir ce répertoire et afficher son contenu4. Member States, WHO and herbal medicines
Ouvrir ce répertoire et afficher son contenu5. Country summaries
Afficher le documentReferences
Afficher le documentAnnex 1. Text of survey instrument
 

3.1 Law or regulation on herbal medicines

In the survey form, reference was made to the previous definitions of laws and regulations provided for TM/CAM. Herbal medicines have been defined above in the Introduction. In addition, in some countries, animal and mineral materials may be present in herbal medicines.

Member States were asked whether laws or regulations existed for herbal medicines; if they replied yes, follow up questions asked for the year of issue of such laws or regulations, and the type of law or regulation. The options for the type of law or regulation included the same law or regulation as for conventional pharmaceuticals, a separate law or regulation for herbal medicines, or a law or regulation partly the same as for conventional pharmaceuticals.

Survey responses indicate that a majority of responding Member States (92 countries, 65%, Figure 12) have laws or regulations on herbal medicines.


Figure 12. Laws or regulations on herbal medicines

Information provided by 77 of the responding Member States about the year of issue of the law or regulation indicates clearly that the development of laws and regulations on herbal medicine is a recent phenomenon (Figure 13). Over the last 15 years, the number of Member States with laws and regulations on herbal medicines has increased dramatically. The highest number of laws and regulations on herbal medicine were issued between 1996 and 1999.


Figure 13. Number of Member States with laws or regulations on herbal medicines, by year

Responses from those Member States having laws or regulations governing herbal medicine largely indicate that these are similar to laws or regulations on conventional medicine (see Figure 14). As responding Member States were able to choose all categories of law or regulation as required, the total number of answers in the chart below exceeds the number of respondents. As many Member States have more than one law or regulation pertaining to herbal medicines, many Member States indicated more than one category for the type of law or regulation. The total number of Member States which responded to this question was 91.


Figure 14. Type of law or regulation on herbal medicines

Finally, Map 6 below illustrates the Member States responding to the Global Survey which have laws or regulations on herbal medicines.


Map 6. Member States with law or regulation on herbal medicines

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