Earlier this year, ForeignExchange was selected by the Regulatory Affairs Professional Society to do the Japanese-to-English translation of their Fundamentals of Japanese Regulatory Affairs book. Well, just this week, RAPS announced that the English edition has been published and is available for pre-order at their online bookstore.
The original Japanese version of Fundamentals of Japanese Regulatory Affairs was released in January 2010. In order to provide an English edition, RAPS set out to find a suitable translation provider who could not only handle the language requirements but also the specific subject matter of drug and device regulatory affairs. After screening several translation companies through an RFI process and test translations, RAPS selected ForeignExchange. We worked on the project for several weeks, translating and laying out the English language book. Our linguists and internal project team have done many regulatory translation projects over the years and this experience was a great help.
Now the book is available to English readers who want to learn more about getting products approved in Japan. The book, according to RAPS, "is a comprehensive source of information on submissions, licensing and distribution requirements and postmarket obligations for drugs, biologics, medical devices and in vitro diagnostic products including, including notifications from MHLW and PMDA."
RAPS publishes books that help regulatory professionals navigate the complex labyrinth of international drug and device approvals. The books are also used as study guides for the Regulatory Affairs Certification (RAC) exams. RAC is the only professional certification available in the healthcare sector. RAPS provides RAC for US, European Union, Canadian and General Scope regulatory affairs. The forthcoming Japanese regulatory affairs book will further enhance its offerings.
You can pre-order a copy of the book on the RAPS web site.
For more on Japan, take a look at the following articles:
- Best practices for Japan regulatory submissions
- Japanese "device lag" disappearing?
- Software localization requirements in Japan
- Working with Japanese affiliates
ForeignExchange Translations provides specialized medical translations for regulatory submissions, labeling, and safety reports - in Japanese and dozens of other languages. Contact us to find out more.