The Medicines and Healthcare products Regulatory Agency (MHRA) aims to ensure that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness. It set up the initiative to improve information management and speed submissions for pharmaceutical and medical technologies firms.
The new portal, which is expected in the fall, will be the central point of interaction between the pharmaceutical industry and the MHRA, enabling the agency to electronically manage applications and requests for information.
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, which include applications for product and manufacturing licenses and export certificates, to allow the MHRA to assure data quality and carry out two-way dialogues with applicants and industry organizations.
All forms will automatically enter the Accenture-developed electronic workflow system at the MHRA via built-in XML capabilities.
The MHRA is also working with Accenture on a larger initiative to build and implement new information systems, which are intended to help the Agency process applications and requests more efficiently and ensure that safe and effective products are available to patients in a timely way.
“The process of regulating medical and pharmaceutical advances is difficult and time-consuming,” said Pierre van Beneden, vice president, Europe, Middle East and Africa for Adobe. “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.”