National Policy on Traditional Medicine and Regulation of Herbal Medicines - Report of a WHO Global Survey
(2005; 168 pages) Ver el documento en el formato PDF
Índice de contenido
Ver el documentoAcknowledgements
Ver el documentoExecutive summary
Ver el documentoAcronyms, abbreviations and definitions
Ver el documentoWHO Regions
Abrir esta carpeta y ver su contenido1. Introduction
Abrir esta carpeta y ver su contenido2. National policy on traditional medicine and complementary/alternative medicine
Cerrar esta carpeta3. The regulatory situation of herbal medicines
Ver el documento3.1 Law or regulation on herbal medicines
Ver el documento3.2 Regulatory status of herbal medicines
Ver el documento3.3 Claims
Ver el documento3.4 Pharmacopoeias
Ver el documento3.5 Monographs on herbal medicines
Ver el documento3.6 Manufacture of herbal medicines
Ver el documento3.7 Safety and herbal medicines
Ver el documento3.8 Registration system for herbal medicines
Ver el documento3.9 Herbal medicines and the essential drug list
Ver el documento3.10 Post marketing surveillance of herbal medicines
Ver el documento3.11 The sale of herbal medicines
Ver el documento3.12 Annual market sales of herbal medicines
Abrir esta carpeta y ver su contenido4. Member States, WHO and herbal medicines
Abrir esta carpeta y ver su contenido5. Country summaries
Ver el documentoReferences
Ver el documentoAnnex 1. Text of survey instrument

3.5 Monographs on herbal medicines

Member States were asked a series of questions concerning the existence of national monographs on herbal medicines. As defined in the survey form, monographs on herbal medicines are descriptions of different herbal medicinal formulae, which either are included in a pharmacopoeia or exist separately (12). If Member States indicated that national monographs existed, the bibliographical information was solicited and the question of the legal status of the national monographs was posed. If Member States indicated that they lacked national monographs, they were asked whether such monographs were in the process of development and, further, if other monographs were in use. If indicated, the bibliographical and legal status of other monographs used was solicited.

Of the responding Member States, 46 (33%) reported that they had national monographs on herbal medicines (Figure 23): furthermore, of the 84 countries that reported not having national monographs, 25 (28%) indicated that national monographs were in development.

Figure 23. National monographs on herbal medicines

Of the 84 countries which lack national monographs, 38% (34 countries) reported the use of other monographs, as illustrated in Figure 24.

Figure 24. Other monographs used in the absence of a national monograph

In place of national monographs on herbal medicines, many countries reported the use of multiple monographs. Detailed information on the major categories of monographs used was given by 30 countries and is presented in Figure 25. These figures are based on the responses given by 27 countries; however, as many countries used multiple monographs, the total numbers presented in Figure 25 exceeds the number of responding countries.

Figure 25. Other monographs used

As presented in Figure 25, the WHO monographs series was reported as being used by the largest number of countries, followed by the European pharmacopoeia and the European Scientific Cooperative on Phytotherapy monographs (ESCOP monographs). Almost all the monographs reported by responding countries are included in the various pharmacopoeias.

Finally, countries which reported having national monographs and those reporting their use of other monographs were asked about the legal status of the monographs (see Figure 26 and Figure 27). Of the 46 countries with national monographs, 52% (24 countries) reported that their monographs were legally binding. Of the 34 countries that reported using other monographs, 44% (15 countries) reported that such texts are legally binding.

Figure 26. Legal status of national monographs

Figure 27. Legal status of other monographs

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