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

3.4 Pharmacopoeias

Member States were asked a series of questions concerning the existence of a national pharmacopoeia that includes herbal medicines. A pharmacopoeia is a formulary, especially an official one and usually one having legal force in all pharmacies of a given country, containing a description of drugs used in current medical practice and noting their formulae, analytical composition if known, physical constants, main chemical properties useful for identification and mode of preparation of compound preparations/combination products. Details may also be included of assay methods to regulate purity, content of active principle, preservation of quality and, where appropriate, biological potency (11).

If Member States indicated that a national pharmacopoeia existed, the survey asked for bibliographical information about it and asked about its legal status. If Member States indicated that they lacked a national pharmacopoeia, they were asked whether one was being developed and, further, whether another pharmacopoeia was in use. If indicated, the bibliographical details and legal status of other pharmacopoeias used were solicited.

As illustrated in Figure 18, only 24% (34 countries) of the responding countries indicated that a national pharmacopoeia existed and was in use. Of the 104 countries lacking such a national pharmacopoeia, 25% (26 countries) indicated that such a document was in preparation.

Figure 18. Number of Member States with a national pharmacopoeia

As shown in Figure 19, of those 104 Member States lacking a national pharmacopoeia, 56% (58 countries) indicated that another pharmacopoeia was in use. Detailed information about the pharmacopoeia which was used in the absence of a national pharmacopoeia was provided by 52 Member States and listed below in Figure 20. Many countries reported the use of several different pharmacopoeias, the sum of all the responses in Figure 20 therefore exceeds the number of respondents. Finally, 31 countries (30%) reported not using any pharmacopoeia.

Figure 19. Other pharmacopoeias used in the absence of a national one

Figure 20. Details of other pharmacopoeias used

The survey results indicate that the European pharmacopoeia is used most frequently (by 14 countries) where no national pharmacopoeia is available, followed by the British pharmacopoeia and the United States pharmacopoeia. However, these figures are inflated by the fact that the European pharmacopoeia has been adopted by the European Union as its official guide; as many of those countries reporting use of the European pharmacopoeia are in the European Union, their survey replies tend to overemphasize the global use of this pharmacopoeia. If the official signatories to the European pharmacopoeia are excluded, six other countries use this pharmacopoeia.1

1 Based on the list of parties in the European pharmacopoeia, 4th ed., 2002. However, four of these countries were observers at the time and may have joined the European Pharmacopoeia Commission since.

Finally, countries were asked about the legal status of the national or other pharmacopoeia used (Figure 21 and Figure 22). In 85% of the 34 countries with a national pharmacopoeia, the information it contains is legally binding. In 59% of the 58 countries using another pharmacopoeia, the information contained in the other pharmacopoeia is legally binding.

Figure 21. Legal status of national pharmacopoeias

Figure 22. Legal status of other pharmacopoeias

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