Traditional Medicine in Asia

Traditional Medicine in Asia
Different national statutes require
different types of information and data to
be submitted with applications for
registration of herbal products. Some
countries, including Turkey and the
Philippines, require information on the
registration status of the product in other
countries, and in case of the latter, information
on the manufacturing operations
and facilities.
Manufacture, Import, Export,
Sale and Dispensing
In most countries, the manufacture,
import, export, dispensing and sale of
medicinal plants are not specifically
regulated. Depending on the scope of the
law these may be governed by provisions
applicable to medicinal products in
general or, alternatively, this field of activity
may remain essentially laissez-faire.
Hence, it is not usual to establish by law
separate mechanisms to deal specifically
with certain aspects of medicinal plants.
Regulatory competence in nearly all
countries is vested in the national drug
authority. France is among the few
countries in which a separate authority
has been established: the National
Interprofessional Office has certain
statutory powers and responsi-bilities with
regard to plants, parts of plants, and the
products of initial processing of these
materials.
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The extent to which
elements of Good
Manufacturing Practices are
applied to the manufacture
of plant-based medicinal
products is varied.
China features prominently among
countries that have issued regulations
specific to traditional herbal medicines.
Detailed provisions have been promulgated
on their preparation which specify
standards and requirements to be
maintained in manufacturing facilities and
by personnel. In Indonesia, traditional
medicines can be manufactured only under
a licence granted by the Ministry of Health.
Hungary permits the marketing and
processing of only those medicinal plants
that have been inspected by the Medicinal
Plants Research Institute and for which a
certificate of inspection has been granted.
In Singapore, the statutory requirements
concerning manufacture do not apply to
products prepared exclusively by drying,
crushing or comminuting plants or parts
of plants.
The extent to which elements of Good
Manufacturing Practices are applied to the
manufacture of plant-based medicinal
products is varied. Insofar as the European
Community is concerned, guidelines for the
manufacture of herbal medicinal products
were drafted in 1990 under the aegis of
the Committee for Proprietary Medicinal
Products.
These guidelines are intended to
supplement the EC text of good manufacturing
practices.
Statutory provisions bearing specifically
on the import of medicinal plants are
uncommon. Countries that require
registration of herbal medicinal products
generally have the power to regulate their
import; any restrictions applied specifically
to medicinal plants are usually set out only
in regulations.
A number of countries have recently
reported that some imported herbal
products have been found to contain nonlabelled
substances that are potentially
harmful to health. Malaysia, for instance,