ISI Releases Next Major Software Version for Japanese Market to Address Fast Move to Paperless Environment for Regulatory Submissions
ISI strengthens leading market position in Japan by adding new functionality to its regulatory suite, and automating and streamlining tasks required by the PMDA
Whippany, NJ- June 2, 2010 - As Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) moves aggressively to create a stable infrastructure to accept regulatory submissions in the electronic Common Technical Document (eCTD) format, ISI, a market-leading software and services vendor in Japan with 45 percent market share, today announced the availability of the newest version of its Regulatory Solutions Suite (RSS) to accommodate the specialized requirements of the Japanese market. The improved RSS product, which will be implemented in partnership with CAC Corporation, offers new features and functionality and an enhanced Japanese user interface to give companies greater flexibility to manage eCTD and paper submissions.
“The PMDA has requirements that other regulatory authorities do not have, so it is critical that we use a submission tool like ISI’s Regulatory Solutions Suite, specifically designed for this market and this regulator,” said Atsushi Tomaru, Ph. D head of regulatory operations, Clinical Science Department, at Kyowa Hakko Kirin Co.
The comprehensive RSS offering couples ISI’s flagship products eCTDXPress and ISIPublisher. In addition to a more robust Kanji character user interface, the latest version of RSS also assures the validity of all links throughout the eCTD via a notification system that alerts users when links have been broken. With submissions containing hundreds of documents and many more links, a compromised link can result in a cascading effect of broken links. The PDMA’s guidelines require redirecting broken external links even if the file content stays the same. If the re-work were done manually, it would be prone to errors and slow cycle times.
The Japanese pharmaceutical market is the second largest in the world with sales of $60 billion, constituting approximately 11 percent of the global marketplace. Following the introduction of the eCTD submission format in June 2004 – when companies were required to supplement submissions with several paper copies – the PMDA began exclusively accepting electronic submissions with minimal paperwork in April 2009. Since then, approximately 40 percent of companies registered with the PMDA have had experience with eCTD submissions (original or reference). According to Yoshihiko Inazumi of PMDA, the total number of original eCTDs (initial submissions) from 2004-March 2009 was 11, while the number almost doubled from April 2009 – February 2010.
“Errors such as broken links hinder the mutual trust companies have with the PMDA, potentially discouraging the recent acceleration of eCTD acceptance in Japan,” continues Tomaru. “With partners like ISI and CAC providing products like the enhanced RSS, we can rest assured that we have the solutions to streamline our submission efforts.”
Tags: Regulatory submissions; electronic submissions; pharmaceutical industry; eCTD; Pharmaceuticals and Medical Devices Agency; PMDA; eCTD Validator
Suggested Links: ISI;CAC Corporation; Kyowa Hakko Kirin Co; Japan’s Pharmaceuticals and Medical Devices Agency; electronic Common Technical Document; Regulatory Solutions Suite (RSS)
About CAC Corporation
CAC Corporation is an IT system consulting and system integration provider and contract research organization (CRO) comprised of 700 professionals and specialized in pharmaceutical research, development and post-marketing. Founded in 1966, CAC has clients in industries such as banking, securities, insurance, media and food/consumer goods. CAC has provided consulting, system integration and system operation for more than 60 pharmaceutical companies, including global pharmas, for over 40 years.
CAC provides PRASMA (Pharmaceutical Research Advanced Solutions and Management), which represents a comprehensive solution encompassing all five phases of pharmaceutical R&D, featuring expendability to support the system integration opportunities that may arise in the course of mergers involving domestic and overseas companies, as well as also supporting a high level of security. http://www.cac.co.jp/english/e_index.html