National
policy on traditional medicine and regulation of herbal medicines:
Report of
a WHO global survey 2005
In the WHO Region of the Americas, there are
considerable differences in the kinds of policies and regulations that have
been developed. Many countries have regulation and registration systems for
herbal medicines, yet the number of countries developing similar laws,
regulations or national policies on TM/CAM is relatively small. However,
the number of countries having expert committees, national research institutes
and national offices is much higher, which may mean that such policies and
regulations are being developed, or will be in the future.
Eighteen of the 35 countries of the WHO Region of the
Americas responded to the Global Survey. Table 5 summarizes the development of
national policy and regulation of TM/CAM and herbal medicines in the Region of
the Americas, with comparative figures for all the responding countries and the
global percentages. The figures and percentages represent those countries
responding positively to the questions. The survey response figures
represent all of the responding countries, either in the region or globally as
indicated.
In the Federative Republic
of Brazil, there is currently no national policy on TM/CAM, but the Ministry of
Health is elaborating the Natural Medicine and Complementary Practices National
Policy, which includes phytotherapy, acupuncture, homeopathy and anthroposophic
medicine. A standardization proposal for the use of medicinal plants and
phytotherapeutic medicines in the Sistema Único de Salud (Unified Health
System - SUS) is being drafted. Laws and regulations and a national programme
are in preparation. There is no national office or expert committee, nor are
there national research institutes.
Regulation of herbal
medicine has existed in Brazil since 1967, and the fourth version of the
regulations, RDC 48/2004, was put in place in 2004. It is partly the same as
the legislation on conventional pharmaceuticals. Herbal medicines are regulated
in the following categories: herbal drugs (both prescription medicines and over
the counter medicines), functional foods, probiotics, bioactive substances and
cosmetics. Medical claims can only be made if the product is registered as a
herbal drug. The national pharmacopoeia is the Farmacopéia brasileira (4th
ed., 1988); the information it contains is legally binding. The national
pharmacopoeia also contains the national monographs.
The regulatory requirements
for manufacturing include adherence to the information contained in
pharmacopoeias and monographs, and the same rules of good manufacturing
practice as for conventional pharmaceuticals, as well as special rules. These
requirements are ensured through certification of GMP for the production and
pharmaceutical areas. Safety assessment requirements include the same requirements
as for conventional pharmaceuticals and special requirements of traditional use
without demonstrated harmful effects; again, there is no existing control
mechanism, but reference is made to documented scientific research on similar
products. The implementation of these requirements is ensured through annual
inspections.
There are more than 1000
herbal medicines registered in Brazil; none is included on the national
essential drug list; however, a list of phytotherapeutic medicines is currently
being prepared for inclusion. There is a post marketing surveillance system
that includes adverse effect monitoring, established in 2001. Herbal medicines
in Brazil are sold in pharmacies as prescription and over the counter
medicines. In 2001, the total sales of herbal medicines reached an estimated
US$ 400 million.
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