Abstract
"Historically, getting products approved in Japan has been slower than in
other regions … However there has been some change in this recently
‘foreign’ data is becoming more acceptable."
This single volume report, is a concise summary of the legislative framework
and the filing procedure for achieving product approval in Asian markets.
Key coverage
- Take a detailed look at the legislative and regulatory framework in
place - particularly for Japan and China.
- Understand the filing procedures required to bring an animal drug
product to market in Asia effectively and efficiently.
- Use the report to plan a submission and to help you discuss your
plans with your chosen local collaborator.
- Discover the problems faced by the Chinese veterinary medicines
industry and the recent regulations implemented that could mean opportunities
for your business.
Key findings
Despite the differences compared with the EU and the US, many products are
successfully authorized for sale in Japan, which remains a major commercial
potential for any veterinary medicinal product that can be sold throughout the
world.
The Chinese industry has an urgent need for standardization. As the market
opens, China will be flooded with imported products. For domestic producers to
be able to compete, the regulatory system needs urgent improvement.
Find out the main acts and regulations as well as guidance on getting
approvals and practical tips to speed up the approval process.
Examine the regulatory culture in the rapidly expanding Indian market, which
has been reluctant to adopt global policies due to the nature of that
particular market. Changes since the last Animal Pharm report on the Indian
animal health market are listed and discussed.
Chapters include
Legal framework, detailed data requirements, regulatory procedures in Japan
for approval and licensing, where to find guidance on regulatory requirements,
regulations in China, product registration and regulation in India.
Who should read this report?
This report will be an ideal guide for:
- Newcomers to the regulatory profession
- Generics manufacturers in or outside of Asia
- Or drug developers wanting to market their products in Asia
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