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International Regulation of Natural Health Products (Paperback)
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Discovery Miles 6 270
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International Regulation of Natural Health Products (Paperback)
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This book reviews natural health product laws and regulations for
Canada's primary natural health products (NHP) trading partners,
namely, Australia, China, France, Germany, Hong Kong, India, USA,
United Kingdom, and the European Union and compare them to Canada's
natural health product regulations. The study was also undertaken
to identify priority areas where policy research should be focussed
and then propose strategies to address these selected policy
research areas. The Canadian NHP definition was used to compare
similar classes of products for these other countries. Further, the
major components of the Canadian regulatory framework for NHPs that
were used for research purposes were the following: Product
Licensing including Standards of Evidence, Site Licensing, Good
Manufacturing Practices and Adverse Reaction Reporting. Tables of
regulatory information were prepared for each country, providing
sections for certain aspects of the Canadian NHP regulatory
framework and including the main governmental regulatory authority
for each country. This work reveals a fast-paced change and
revision of national and international regulations for NHPs such as
herbals, vitamins, minerals and homeopathic medicines. Many changes
in the European countries were precipitated by the implementation
of European Union Directives. Canada's major trading partner, the
United States, classifies some NHPs as dietary substances, while
other NHPs are under the U.S. FDA's control as non-prescription
medicine and homeopathic medicines which are classified as drugs.
In the United States, dietary substances require little regulatory
scrutiny yet the regulatory environment in the United States is
moving toward a more regulated system. Strategies for prioritizing
policy research needs in the area of international regulations of
Natural Health Products (NHPs) were developed. The priority areas
for policy research fell into two main categories: the safety of
the products being manufactured and sold to Canadians and processes
to facilitate trade between countries. The overall aim for trade
development should be to look for methods and means of further
harmonization with trading partners and to develop Mutual
Recognition Agreements (MRAs).
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