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
