The new Animal Pharm report presents the legislative framework of the Asian countries in quite some detail to provide the reader will a well-rounded overview of the policies operating in those markets Photo: Rita Juliana

Historically, getting products approved in Japan has been slower than in other regions and there are two reasons for this. First, data requirements in Japan have been rather specialized, and certain key data (for example, clinical trials) have always had to be generated in Japan. There has been some change in this recently and the Japanese authorities are now more ready to accept 'foreign' data than before.

However, there remain certain key studies that must always be carried out in Japan and this can mean, in many cases, that studies that have already been carried out elsewhere must be repeated for submission in Japan. The second reason why submissions have been slow to progress in Japan is because of the need to set up a collaborative framework with personnel in Japan who can advise on the preparation of the data and actually carry out the submission in Japan, liaising directly with the Japanese authorities. In multinational companies these arrangements are already established but outside these organizations the collaboration has to be set up, sometimes using consultants who are based in Japan.

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 information and guidance in this report will give you the necessary background to permit you to plan a submission in Japan and to discuss your plans with your chosen local collaborator.

Ivy Du takes up the baton to give an overview of relatively recent regulatory changes in China. The regulations adopted by the State Council and overseen by the Ministry of Agriculture are listed in detail. Manufacturing and Production has been expanding rapidly in this and the Indian markets, which have both seen a rapid expansion of facilities and producers of generic products.

Dr R B Smarta then examines 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.

This report presents the legislative framework of these countries in quite some detail to provide the reader will a well-rounded overview of the policies operating in those markets.

> Read the executive summary