UltraXML Solutions for the Pharmaceutical Industry
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Pharmaceutical companies’ aims are to deliver new drugs as fast as possible
and to prove the safety and effectiveness of these drugs taking into
consideration that the limited life span of any new drug is governed by many
international patent and regulation restrains.
Pharmaceutical companies are
under increasing pressure to absorb the new advances in the genetic and
biotechnology sectors while at the same time face severe competition that
requires an optimized efficiency to enable them to stay profitable.
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Taking this into consideration,
Pharmaceutical companies have realized the urgent need to use the latest IT
standards and tools of which XML technology is a major player.
XML as a content format and subsequently as data exchange offers the best
possible approach to an open standard for content managing, exchanging
content and multimedia publishing.
XML’s ability to handle a
variety of structured and semi structured drug-related information, reusing
content in regulatory submissions, multi-channel publishing and internet
portals and websites, and knowledge management systems, makes a very
compelling business case for XML technology.
The pharmaceutical industry
is actively considering XML as a key enabling technology to help meet its
content management and delivery needs. XML also offers real opportunities to
bring interoperability to the many systems that support clinical care
(healthcare) and clinical research (pharma). Pharmaceutical companies should
be aware of the numerous XML-based standards and regulatory submission
requirements that are emerging. UltraXML makes use of all available XML
standards and regulations and offers one of the most comprehensive and easy
to use solutions available to the Pharmaceutical industry.
XML-based standards and Regulatory Agencies
The International Conference
on Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH) is a unique project that brings together
the regulatory authorities of Europe, Japan and the United States and
experts from the pharmaceutical industry in the three regions to discuss
scientific and technical aspects of product registration.
The purpose is to make
recommendations on ways to achieve greater harmonization in the
interpretation and application of technical guidelines and requirements for
product registration in order to reduce or obviate the need to duplicate the
testing carried out during the research and development of new medicines.
The objective of such harmonization is a more economical use of human,
animal and material resources, and the elimination of unnecessary delay in
the global development and availability of new medicines whilst maintaining
safeguards on quality, safety and efficacy, and regulatory obligations to
protect public health. This Mission is embodied in the Terms of Reference of
ICH.
The International Conference
on Harmonization (ICH) - has published version 3.2 of the eCTD. This is the
most efficient way to submit the information needed for marketing
authorization from the regulatory authorities.
The eCTD essentially consists
of an XML file (index.xml), a file structure, and a number of PDF and XML
files. The XML file describes the file structure, checksums for these files
and meta-information about the files including version, operation status,
role, keywords …etc.
Module 1 of the eCTD
(regional information) further contains 3 additional XML files (for each
region one). These contain meta-information (e.g. applicant, product,
submission date ...), and links to the files with the actual submission
information.
eCTD will also be used for
safety updates, annual reports, variations, amendments, etc. Over time, the
US Investigational New Drug Application (IND) will most likely be submitted in eCTD format. Starting July 2003, the eCTD is mandatory in the EU,
Switzerland, Japan, Canada and highly encouraged in the US.
The XML eCTD DTD includes a
reference for each document to the physical file within the folder
structure. The XML eCTD DTD includes attributes for descriptive names of
folders and documents. [from the version 2.0 spec]
One important way XML
provides value for eCTD is by supporting “what’s changed” transactions
(i.e., add/delete/update), instead of requiring full document replacement.
This helps the company limit the volume of submission material to be
reviewed and sent and lets the agency reviewer focus on the changes without
having to wade through large amounts of previously reviewed material.
U.S. Food and Drug Administration - FDA
The FDA is responsible for
protecting the public health by assuring the safety, efficacy, and security
of human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and products that emit radiation. The FDA
is also responsible for advancing the public health by helping to speed
innovations that make medicines and foods more effective, safer, and more
affordable; and helping the public get the accurate, science-based
information they need to use medicines and foods to improve their health.
XML Initiatives in Regulatory Submissions
Adverse Events Reporting System (AERS)
One of the earliest
initiatives to introduce XML and automate regulatory submissions was the
International Committee on Harmonization (ICH) Adverse Events Reporting
System (AERS) initiative. Historically, patient adverse events have been
submitted to regulatory agencies using forms, called Individual Case Safety
Reports (ICSRs). The ICH has created E2B, a regulatory e-submission format,
adopted in the US by the FDA and in Europe in an XML variant, to be used
with Electronic Data Interchange (EDI) to enable electronic submission of
ICSRs. This electronic approach allows communication between the company and
the agency to take place in an automated way, with less time and fewer
errors than the paper process.
Investigational New Drug Application Cumulative Table of Contents (cTOC)
Investigational New Drug
Application Cumulative Table of Contents IND (cTOC), submissions are
required at various steps during a drug’s development process. In order to
facilitate the review of these submissions, the FDA has prototyped an
XML-based cumulative table of contents (cTOC). This XML document links
submissions together and allows navigation of submission documents as an
agency review aide. The cTOC review tool is expected to be modified to use
the eCTD standard in the future. XML and the Pharmaceutical Industry 4
European Agency for the Evaluation of Medicinal Products - EMEA
Product Information Management - PIM
Pharmaceutical companies can
now submit their Product Information (PIM) to the European Agency for the
Evaluation of Medicinal Products
EMEA in XML-format. This not only saves Regulatory Affairs departments a
lot of work, but also enables EMEA to review the information considerably
faster. This means that Pharmaceutical companies, through the use of
XML-technology, can considerably shorten the time-to-market of new products.
Furthermore, the product information can much more easily be reused within
the company.
PIM initiative involves the creation and authoring of XML data in
accordance with a set XML DTD and the use of a content management system, CMS, for submission, creation
and maintenance.
Structured Product Labeling - SPL
Since 1999, FDA has been receiving the
electronic content of labeling in Portable Document Format (PDF). However,
existing procedures using PDF are not adequate to support new electronic
healthcare initiatives. On December 11, 2003, FDA published final
regulations (the electronic labeling rule) requiring the submission of the
content of labeling in electronic format for marketing applications. The
regulations specify that the content of labeling must be submitted
electronically in a form that FDA can process, review, and archive.
The Structured Product Labeling (SPL)
specification, an HL7 ANSI-approved standard, is an XML document markup
standard that specifies the structure and semantics for the regulatory
requirements and content of the authorized published information that
accompanies any medicine licensed by a national or international medicines
licensing authority. An SPL document has sections containing text
(paragraphs, lists, tables). SPL markup of a product labeling document both
preserves the human readability of the content and facilitates machine
processing of that content.
UltraXML Supports the production of SPL document
Clinical Data Interchange Standards Consortium- CDISC
CDISC is an open,
multidisciplinary, non-profit organization committed to the development of
industry standards to support the electronic acquisition, exchange,
submission and archiving of clinical trials data and metadata for medical
and biopharmaceutical product development. The mission of CDISC is to lead
the development of global, vendor-neutral, platform independent standards to
improve data quality and accelerate product development.
Operational Data Model - ODM
The Clinical Data Interchange
Standards Consortium has developed an Operational Data Model (ODM). This is a vendor neutral, platform
independent format for interchanging and archiving of data collected in clinical
trials. The model represents study metadata, data and administrative data
associated with a clinical trial. Only the information that needs to
be shared among different software systems during a trial, or archived after
a trial is included in the model.
ODM version 1.2 contains a
number of new features that improve the functionality, security and
convenience of the model. Descriptions of the new features have been
incorporated into the text of this document. |
