Electronic Forms, Information Management at Heart of New Electronic Submissions Strategy to Streamline Regulatory Approval Process
NEW YORK; March 17, 2005 – Accenture (NYSE: ACN) and Adobe Systems Incorporated (Nasdaq: ADBE) announced they are helping the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK develop an online portal. The initiative is designed to help improve information management and help speed submissions for pharmaceutical and medical technologies firms. The mission of the MHRA is to ensure that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness and are used safely.
The new portal, which will be launched in the fall, will be the central point of interaction between the pharmaceutical industry and the MHRA – enabling the agency to electronically manage tens of thousands of applications and requests for information each year.
The MHRA is also working with Accenture on a larger initiative to build and implement new information systems. Together, these new systems will help the Agency to process applications and requests more efficiently, and ensure that safe and effective products are available to patients in a timely way. The portal, designed and implemented by Accenture, is based on Adobe’s Intelligent Document Platform®. Adobe products will be used to create 30 intelligent forms that will allow the MHRA to assure data quality and carry out two-way dialogues with applicants and industry organizations. These forms include applications for product and manufacturing licenses, and export certificateS.
Doreen Hepburn, director of information management, MHRA commented: “The agency believes that electronic submission technologies and the accompanying process changes will improve the efficiency of our interaction with industry. We are pleased with how Accenture and Adobe are helping us make this portal available to our industry stakeholders.
Currently, MHRA applications are submitted and managed using paper-based forms. Forms are, on average, three to four pages long but require attachments that are typically hundreds of pages, making information costly to process, share and archive. Through use of Adobe’s PDF technology, each application and its supporting materials, including images and complex calculations, can be contained within a PDF form that is easy to use, search and archive. Additionally, all forms will be pre-populated with existing information in the MHRA database to ensure that details are correct.
All forms on the MHRA portal have built-in XML capabilities which mean that they automatically enter the Accenture-developed electronic workflow system once at the MHRA.
“This work is an important step toward realizing the vision of faster, better, more accurate documents and information exchange between the MHRA and industry,” said Ken Lacey, managing partner of Accenture’s Health & Life Sciences practice. “More efficient communication has the potential to assist the MHRA to serve its customers more effectively."
Pierre van Beneden, vice president, Europe, Middle East and Africa for Adobe added: “The process of regulating medical and pharmaceutical advances is difficult and time-consuming. Intelligent document workflows give agencies such as the MHRA the opportunity to accelerate time-to-market for the drugs and medical technologies that are improving lives every day around the world.”
About Adobe Systems Incorporated
Adobe is the world’s leading provider of software solutions to create, manage and deliver high-impact, reliable digital content. For more information, visit www.adobe.com.
MHRA is the Government agency regulating the safety and effectiveness in use of medicines and medical devices. The Agency enhances and safeguards the public’s health by making objective, fact-based and sound judgments and offering guidance to patients and users in an accessible form. MHRA seeks to act always in the best interests of patients and users. Its home page is www.mhra.gov.uk.
Accenture is a global management consulting, technology services and outsourcing company. Committed to delivering innovation, Accenture collaborates with its clients to help them become high-performance businesses and governments. With deep industry and business process expertise, broad global resources and a proven track record, Accenture can mobilize the right people, skills and technologies to help clients improve their performance. With more than 100,000 people in 48 countries, the company generated net revenues of US$13.67 billion for the fiscal year ended Aug. 31, 2004. Its home page is www.accenture.com.