Reports the findings and
recommendations of a working group convened to prepare guidelines for
the use of herbal medicines in Western Pacific countries. Addressed to
national health authorities, the report responds to the widespread use
of herbal medicines in this part of the world and the corresponding need
for mechanisms to ensure that these products are safe and effective,
yet remain broadly accessible. With this need in mind, the report sets
out a comprehensive framework for developing national policies designed
to control the safety, efficacy, and quality of herbal medicines,
manufacturing practices, product registration, and labelling, marketing,
and trade.
The report has two parts. The guidelines are presented in the
first, which opens with background information about the objectives of
national policies aimed at the promotion, development, and regulation of
herbal medicines. The need to define the place of traditional care
within modern health systems is discussed together with the importance
of conserving plant species. Against this background, the guidelines are
presented in five chapters. General guidelines for the development of a
national policy are followed by advice on the process by which national
policies are developed and implemented. Ten specific issues that need
to be addressed are identified and discussed.
Subsequent chapters outline legal and other options available for
the regulation of practitioners, manufacturers and the distribution
system. The guidelines conclude with a description of the different
regulatory procedures that can be applied to raw plant materials,
processed plant materials, and medicinal herbal products. The regulation
of medicinal herbal products is discussed in terms of detailed
requirements for the registration of both traditionally used products
and new products. The chapter also includes advice on labelling
requirements, the responsible government agency, and establishment of a
system for monitoring adverse reactions.
The second part includes a summary of the working group's
deliberations and conclusions, followed by brief reports from 14 Western
Pacific countries, which document the importance of herbal medicines
and summarize existing systems for their regulation and control.
http://apps.who.int/medicinedocs/en/d/Jh2945e/
No comments:
Post a Comment