Herbal medicines are the most widely used traditional medicines. The most important challenges are those of safety, efficacy and quality of herbal medicines. These depend on adequate regulation.
In 1994, WHO contacted countries to collect information on the regulation of herbal medicines. Unfortunately, only 52 countries out of 191 responded. A WHO publication entitled Regulatory situation of herbal medicines: a worldwide review (3) was produced, including information from those 52 countries. At countries’ further request, WHO published Legal status of traditional medicine and complementary/alternative medicine: a worldwide review (4) in 2001. However, much of the information in this document was obtained at second hand Resolution WHA56.31 requests WHO to provide evidence based information to assist Member States in formulating policy and regulations to control the safety, efficacy and quality of traditional medicines. A global survey to collect primary information from national health authorities was therefore necessary WHO decided to establish a global database on national policies on TM/CAM and regulation of herbal medicines, using information obtained from a global survey.
In 2001, WHO developed the Global Survey questionnaire, which focused on the main challenges listed above. The questionnaire was divided into three main parts:
• general review of policy and regulation on TM/CAM
• regulation of herbal medicines
• countries’ needs for future WHO support and technical guidance.
Thanks to our cooperation with the WHO Regional Offices, we received responses from 141 countries, representing 74% of the 191 Member States of WHO at that time (see Map 1)1. The data were entered into the WHO Global Database developed for this survey Table 1 and Table 2 above provide a regional breakdown of those countries which responded to the Global Survey.
1 Since Timor-Leste was not a Member State of WHO at the time and consequently was not included in the survey, all global statistics refer to a total of 191 countries
WHO initiated the draft survey questionnaire in 1998 and began consulting with national drug authorities to ensure that each part of the questionnaire was easily comprehensible. The questionnaire was designed to focus on priority areas in TM/CAM policy and regulation and herbal medicine regulation in order to facilitate a timely and complete response, in view of the time constraints facing national drug authorities.
Map 1. Member States that responded to the survey
Clearly, in each country, the national drug authorities are fully occupied by their considerable volume of routine tasks. In order to minimize the additional burden on them, the information included in the global database covers only national policies on TM/CAM and areas directly related to regulation and registration of herbal medicines. Therefore, other important information which might be of interest to Member States is not included in this survey.
In early 2002, WHO contacted national health authorities, the majority of which were located within national food and drug control agencies, through its Regional Offices and country offices in order to collect data.
The returned surveys were analysed for clarity of the responses, and incomplete and unclear responses were queried. Finally, the draft country profiles featured in Section 5 were distributed to the national authorities of each country for review and correction before this document was finalized. We sincerely thank all the countries that contributed to this report and the Global Survey.
All the data in this document were collected from national drug authorities and clarified where necessary, but there may be still some discrepancies between these primary data and data presented in previous WHO publications on these topics (2, 3, 4). Every effort was made to ensure the clarity and accuracy of the data used in the analysis and presented here, but there may be some mistakes or misinterpretations in the data presented WHO welcomes any updates, clarifications or corrections.
With this survey, WHO has taken a further step towards an increased understanding of TM/CAM policies and regulation of herbal medicines in countries. By using a common approach to the measurement of the regulatory situation in all countries, it will be feasible to conduct a comparative analysis of the results, and major themes and obstacles can be identified. In order to provide continuous support in the future, WHO also requested countries to define their assistance needs. Additionally, the data provided in response to this survey forms a baseline for future understanding of the implementation and impact of the WHO Traditional Medicine Strategy.