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National
medicines policies are the basis for defining the role of TM/CAM
in national health care system, ensuring that the necessary regulatory
and legal mechanisms are created for promoting and maintaining good
practice, assuring the authenticity, quality, safety and efficacy
of TM/CAM products and therapies and providing equitable access
to TM/CAM health care resources as well as information about them. In recognition of this World Health Assembly
(WHA) Resolution, TM urges member states, where appropriate, to
formulate and implement national policies and regulations on TM/CAM
in support of proper use of traditional medicine and its integration
into national health care systems, depending on the circumstances
in their countries.
Safety,
efficacy and quality of TM/CAM enhanced through expanding the knowledge
base on the safety, efficacy and quality of TM/CAM and providing
guidance on regulation and quality assurance standards.
TM/CAM
practices have evolved within different culture in different regions.
As a result there has been no parallel development of standards
and methods, either national or international for evaluating them. This is especially true of herbal medicines. The efficacy and quality of which can be influenced
by numerous factors. The
regulation and registration of herbal medicines are the key measures
to ensure their
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safety, quality and efficacy.
The
quality and quantity of the safety and efficacy data on traditional
medicine are far from sufficient to meet the criteria needed to
support its use worldwide.
One
of the reasons for the shortage of research data is the lack of
the financial incentives as most of these products are not covered
by patents. Scientifically
justified and accepted global research methodology for evaluating
the efficacy and safety of traditional medicine is a major challenge.
Although
there has been a recent increase in the number of governments that
regulate herbal medicines, national regulations and registration
of herbal medicines vary from country to country.
Where
herbal medicines are regulated, they are categorized in different
ways "e.g. prescription medicines, dietary supplements, health
food".
However,
a group of herbal products categorized other than as medicines,
may also exist within the same country.
Moreover, the regulatory status of particular herbal product
varies in different countries. Regulatory status also determines the access
or distribution route of these products.
An
additional challenge is the increasing popularity of herbal
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products
categorized other than as medicines or foods.
There
is an increased risk of medicine-related adverse events, due to
lack of regulations, weaker quality control systems, and loose distribution
channels (including mail order and internet sale).
The
rational use of TM/CAM depends on a range of factors, including
the need for adequate training, registration and licensing of providers,
proper use of products of assured quality and provision of scientific
information and guidance for the public.
The
efficacy and safe practice of TM/CAM therapies are closely linked
to the qualification of practitioners. Good practice in TM is dependent on proper training,
the registration of practitioners and the licensing of TM/CAM practice.
The
traditional medicines are increasingly used outside the confines
of traditional culture and fare beyond traditional geographical
areas, without proper knowledge of their context and use.
Moreover they are also used in different doses, extracted
in different ways and used for indications which are different from
their traditional intended use.
To compound the problem, contrary to their use in traditional
context, traditional medicines are now often used in combination
with other medicines-a practice which has become a safety concern.
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