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

3.6 Manufacture of herbal medicines

Member States were next asked about regulatory requirements for the manufacture of herbal medicines. Possible answers included the following options: adherence to information in pharmacopoeias or monographs, the same GMP rules as for conventional pharmaceuticals, special GMP rules, no requirements and other requirements. Countries were able to choose all that applied. For clarification purposes, GMP was described as requirements in areas such as quality management, personnel, premises and equipment, documentation, production, quality control, contract manufacture and analysis, complaints and product recall and self inspection (13).

A total of 126 countries responded to this set of questions (see Figure 28). Most countries indicated that the same GMP rules as used for conventional pharmaceuticals were required for herbal medicines. The next largest number was reports of adherence to information in pharmacopoeias or monographs. Six countries provided additional regulatory requirements for manufacturing; these included the following: good hygienic practices, some elements of GMP (requirements about documentation, licensing of manufacture, packing, marking, design of pharmaceuticals), according to the United States Food and Drug Administration (FDA) regulations, and domestic and family practices.

Figure 28. Manufacturing: regulatory requirements

Member States were further asked whether the implementation of the regulatory requirements selected in the previous question was monitored by a control mechanism. If they answered affirmatively, the countries were asked to describe the type of control mechanism. Though 126 countries responded to this question, the figure below represents only the 101 countries that reported having some sort of regulatory requirements (i.e. excluding those countries which responded only “no requirements” or did not answer the previous question). As illustrated in Figure 29, 76%, or 77 countries, indicated that they have control mechanisms for manufacturing regulatory requirements.

Figure 29. Existence of control mechanisms for manufacturing requirements

Many responding countries provided details on the type of control mechanism used to ensure implementation of manufacturing regulatory requirements. Out of these, the most commonly cited control mechanisms were inspection and licensing of products or manufacturers.

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