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Typical Consulting Assignments

Profiling actual development in Japan
The deregulations in the recent years and the adoption of ICH standards in Japan have resulted not only in an increased number of medicinal products registered in Japan but also in the developments unprecedented before in terms of speed and procedure. Certain critically important categories of therapeutic agents - in CNS field, pain control, inflammation, lipid control - attract the attention of the potential overseas product developers due to the large capacity of the Japanese market.

A sample represented by a Memo on a tentative Case Study is available for download here. The format and the contents of the actual Case Study Reports are highly customizable.

Click to download a Sample Case Study Memo | Inquire for more info...

Registrability of new medicinal products in Japan
The Feasibility Study (FS) commences after receiving from the client the confidential information and data - e.g. all results from preclinical studies (research reports), details of the discovery (including any related scientific publications), clinical data (including protocol, IDB, results, AE reports, etc.) The main purposes of the study are to determine the registrability of the product in Japan, and the probability for successful registration, including suggestions for the development plan. Certain requirements are imposed in Japan such as in the preclinical part for long-term toxicity testing and teratogenicity, and in the clinical part - arising from the use of particular compounds. Once agreed on the objectives of the Feasibility Study, it could be carried out within two months. The result of the FS - in the form of a report will provide the overseas medicinal product developer's management with a basis to make a "Go / No Go" decision regarding the entry to the Japanese market.

The format and the contents of the actual FS are highly customizable.

Inquire for more info...

Concise summaries of the Evaluation Reports
The Evaluation Reports as shown for the all approved in Japan medicinal products are large documents - often exceeding several hundreds of pages in Japanese. In many cases the clients of JKS are interested in certain specific results analyzed in the Evaluation Report or in the opinion of the reviewers. JKS provide the extraction of the data from the original Evaluation Report, translation into English and preparation of a Concise Summary.

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 Update of June 2008

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