Drawing on the expertise of i3 Consult, the following reports have been published in internationally acclaimed publications:

Emergence of e-Health Contrary to popular belief, Japan is closing the gap between itself and the U.S. in terms of adopting Internet technology, particularly in areas of online patient information and information disclosure, electronic medical records, e-health business models and Web based applications for regulatory affairs. This article explores how Japan is shaping up to the challenges of e-health. Request a free copy?

eCTD/CTD – Embracing the Japan Transition The International Conference on Harmonisation (ICH), a collaboration of representatives from the US, the European Union (EU) and Japan, has finalized the guidance and specifications on Electronic Common Technical Document (eCTD), a standardized way of sending a CTD-based electronic submission from industry to the regulatory authority, including foreign countries. Regulators and pharmaceutical manufacturers alike predict that implementation of eCTD will eliminate the need to repeat time-consuming and expensive technical tests that have already been performed in other countries participating in the ICH and enable industry to submit applications using a standard format. 
         The Japanese pharmaceutical industry has undergone major changes as eCTD specifications moved closer to finalization. Because of the new approach to electronic submission, pharmaceutical companies in Japan are frequently coming face-to-face with management issues in regulatory work practices and publishing processes. The momentum for change is further hastened by the fact that documentation technology is likely to become obsolete during the average 10-year preclinical-to-launch development lifecycle in Japan. To remain competitive in the global marketplace, pharmaceutical companies in Japan will need to review regulatory submission strategies and integrate processes within the local submission and language requirement infrastructure. Request a free copy? 

More reports due to come!...If your organisation is needing benchmark reporting on a particular issue in today's pharma/biotech/healthcare industry please contact us by clicking here. 

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