SDL launches XML based solution to submit product information in 24 languages
SDL, the leading provider of Global Information Management (GIM) solutions, today announced that through the use of SDL's GIM technology, the first new product approval in 24 languages has been completed following the European Medicines Agency (EMEA) new Product Information Management (PIM) standard.
PIM, the new emerging European standard defines an electronic XML-based submission process that promises to both reduce complexity of the communication between regulator and applicant for each submission and to improve the time (predictability) from submission to decision. The regulatory procedure demands a five-day window between the moment the initial opinion is received (submitted in English) and when the company's specialists have to finalise the product information in a further 23 separate languages.
Using a Global Information Management solution from SDL, GlaxoSmithKline, the first company to take up this new XML based PIM standard, has managed the processes and tasks associated with the translation of the English content into the 23 languages needed for the final submission (information such as the summary of product characteristics, package leaflet and labelling).
"We see many global companies adopting XML to support their Global Information Management strategies, and the emergence of new standards such as SPL in the USA and PIM in Europe confirms that the Pharmaceutical industry follows the same trend", says Matthias Heyn, vice-president life sciences consulting at SDL. "GlaxoSmithKline had the vision to implement an innovative PIM solution and the successful submission is the result. It has been a partnership between GlaxoSmithKline and SDL. Using both SDL technology and our expertise in multilingual XML content management combined with GSK's subject matter experts, to deliver a solution that provides the multilingual quality and consistency necessary for successful submissions and profitable new product introduction."
For more information on Global Information Management and Life Sciences see www.sdl.com/pim
SDL is the leader in Global Information Management (GIM) solutions that empower organizations to accelerate the delivery of high-quality multilingual content to global markets. Its enterprise software and services integrate with existing business systems to manage the delivery of global information from authoring to publication and throughout the distributed translation supply chain.
Global industry leaders rely on SDL to provide enterprise software or hosted services for their GIM processes, including ABN-Amro, Best Western, Bosch, Canon, Chrysler, CNH, Hewlett-Packard, Microsoft, Philips, SAP, Sony, SUN Microsystems and Virgin Atlantic.
SDL has implemented more than 400 enterprise GIM solutions, has deployed over 150,000 software licenses across the GIM ecosystem and provides access to on-demand translation portals for 10 million customers per month. Over 1,000 service professionals deliver consulting, implementation and language services through its global infrastructure of more than 50 offices in 30 countries.
For more information on SDL, visit www.sdl.com.
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Lisa Gillingham or Saskia Stolper at LEWIS
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