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March 23, 2004
AnGes MG Seeks Faster New Drug Approval-Applications Via Document Management System
-Infocom to be systems integrator for application submission system- |
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AnGes MG Inc. is establishing an electronic
document management system for new drug approval-applications,
in order to accelerate the entire process of new drug approval-application
up to the actual granting of approval. In December 2003, AnGes
entrusted systems development to Infocom Corporation (Chiyoda-ku,
Tokyo; CEO: Atsushi Numa). Since then, Infocom has taken charge
of everything from establishing the required parameters up
to development and deployment, with rollout planned for April
2004.
In recent years, the International Conference on Harmonization
of Technical Requirements for Registration of Pharmaceuticals
for Human Use (ICH) (Note 1) has promoted a framework for the
pharmaceutical industry to enable the simultaneous submission
of applications for approval of new drugs in Europe, the United
States and Japan.
Since July 2003, use of the CTD (a standardized application form
common to the three regions) (Note 2) has been mandatory. For
pharmaceutical firms, this means the time required for application
and approval can be reduced, enabling quicker profitability.
Since AnGes also seeks quicker new drug approval applications,
the company is determined to leverage IT technology so that applications
may be submitted more efficiently; for instance, through the
introduction of a CTD electronic document management system and
an overall CTD management policy.
The system now being installed by AnGes is based on the PharmaPortalR/RD
platform, an electronic document management system for new drug
approval-applications released by Infocom last year. Because
Infocom has handled everything from requirement analysis to overall
systems integration, AnGes was able to realize a high-quality
system in a relatively short time.
This system has special capabilities that support document processing
for inter-organization projects, and since it is preconfigured
with information such as standard CTD hierarchical structures,
and templates for saving materials to be used when preparing
applications, it is possible to greatly reduce the time required
for systems development.
Processing tasks such as the preparation, review, checking, correction
and storage of application documentation can also be implemented
quickly and reliably, so that document quality can be increased
and business in general can be accelerated.
Furthermore, since AnGes has a US subsidiary that will also use
the system, Infocom has developed an English version of PharmaPortalR/RD
to complement the original Japanese version.
By adding the English version of PharmaPortalR/RD to its lineup
of document management solution models for the pharmaceutical
industry, Infocom plans to provide services for systems integration
and permanent support to pharmaceutical firms that want to use
the system from their overseas business units.
AnGes embarked a day ago on Phase Three clinical trials through
multi-centered double-blind tests of genetic treatments. With
this milestone AnGes is enhancing its fundamental business environment
with information technology so that new drug approval-applications
and the approvals themselves can be achieved without delay.
This ongoing development has also been conducted while taking
into account the shift to the Electronic Common Technical Document
(eCTD) format, thus steadily laying the groundwork for the electronic
submission standard that is sure to arrive in the future. |
| Notes |
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(Note 1) International Conference on Harmonization
of Technical Requirements for Registration of Pharmaceuticals
for Human Use (ICH)
An international conference that has engaged in activities for the purpose
of harmonizing technical requirements concerning new drug applications in the
US, the EU and Japan since April 1990. The organization consists of 6 industrial
and administrative bodies from the U.S., the European Union (EU) and Japan;
3 observers from the Insurance Bureau of Canada, the European Free Trade Association
(EFTA), and the World Health Organization (WHO); as well as the Secretariat
of the International Federation of Pharmaceutical Manufacturers Association
(IFPMA). To date the ICH has prepared approximately 50 guidelines concerning
the research and development of new drugs, and has promoted areas such as the
research and development of new drugs, as well as the improvement in quality
of resources and their more effective use during the course of examination.
(Note 2) CTD (Common Technical Document)
Denotes the application forms for new drugs shared by the US the EU, and Japan.
While the Japanese Ministry of Health, Labor and Welfare started to accept
CTD submissions in July 2001, in July 2003 the CTD became mandatory as a result
of studies conducted by the ICH. |
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