Member States were next asked a series of questions related to safety and herbal medicines. The first question asked countries to describe those regulatory requirements used for the safety assessment of herbal medicines. The following options were given: same requirements as for conventional pharmaceuticals, special requirements or no requirements. If Member States chose the option “special requirements”, they were further asked to choose all that applied from the following options: traditional use without demonstrated harmful effects, reference to documented scientific research on similar products, and other requirements. If other requirements were selected, the respondents were asked to describe the requirement.
A total of 130 Member States responded to this question: however, as respondents were asked to choose all that applied, there are more responses than respondents for this question (Figure 30). Eighty two countries indicated that special regulatory requirements exist for herbal medicine. Of the remaining responses, 57 countries indicated that the same regulatory requirements for safety assessment apply to herbal medicines as to conventional pharmaceuticals. Finally, 28 countries indicated that no regulatory requirements for safety assessment exist in their country.
Figure 30. Regulatory requirements for safety assessment of herbal medicines
When selecting the category “special requirements”, countries were further asked to choose the relevant categories of special requirement, or to describe other special requirements. Sixty-six countries of the 82 that chose the category of special requirements indicated that their laws and regulations employ the regulatory requirement of traditional use without demonstrated harmful effects, while 53 countries indicated that they had a regulatory requirement for reference to documented scientific research (Figure 31). Please note that, as countries were able to choose all options that apply, the number of responses exceeds the number of responding countries.
Figure 31. Special regulatory requirements for safety assessment of herbal medicines
Twenty-one countries chose the option “other” and provided details on other regulatory requirements for safety assessment. These included the following: clinical studies, bibliographical documents, screening of herbs not suitable for food use, screening for toxic elements, radioactivity and heavy metals, well-established use, traditional literature documentation and toxicological studies.
Finally, countries were asked whether control mechanisms exist for the regulatory requirements for safety assessment detailed above and, if so, a brief description was requested. Though 125 Member States responded, the figure below only includes 106 since it excludes those that did not respond to the previous question, or responded solely that that there are no requirements. Of the responding countries, 67%, or 71 countries, indicated that such control mechanisms exist (Figure 32). The control mechanisms were also specified in some cases, of which licensing and registration, laboratory testing and pharmacovigilance centres were among the most frequently cited.
Figure 32. Existence of a control mechanism for safety requirements