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 (cac.co.jp) 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.
About Image Solutions, Inc. (ISI)
Founded in 1992, Image Solutions, Inc (imagesolutions.com) is a proven market leader and a pioneer in regulatory software and services for the life sciences industry. ISI’s customer-aligned strategy puts complete regulatory solutions and actionable insights into the hands of regulatory leaders and industry decision makers worldwide.
Through innovative technology solutions and a global network of highly experienced consultants, ISI delivers regulatory solutions and services tailored to biopharmaceutical clients’ specific stage of development, needs and challenges. The combination of our proven expertise, flexible delivery models, and strong relationships with regulatory authorities, assures clients that we provide the regulatory guidance and services required to rapidly and cost-effectively navigate the development process. ISI was among the first professional services firms to deliver electronic submissions to the industry and since has delivered thousands of electronic and eCTD submissions.
ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia.