LORENZ docuBridge and eValidator selected by the Chinese NMPA for an eCTD Data Management System
Frankfurt/Main and Beijing, 02 November 2018 // On July 02, 2018, the Chinese National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) selected Shanghai Baosight Software Co., Ltd. in a tender to establish the eCTD data management system, and LORENZ was chosen by Baosight as software provider in this project.
To establish the eCTD data management system, LORENZ will provide docuBridge and eValidator as an eCTD review system, validation system, and document management system required by CDE, as well as corresponding consulting and training services.
The project is a milestone for all parties. Baosight Software and LORENZ are strongly committed to the CDE’s ambitious goal of implementing eCTD submissions as early as 2019.
Since joining the ranks of the ICH – the international body that sets the standards for harmonizing pharmaceutical registrations globally - in June 2017, China has been eager to adopt its standards. This move will widen access to China’s pharmaceuticals market for foreign companies while also enabling local producers to export regulated products much more easily. China’s ICH membership is what has triggered the speedy move to the eCTD format.
“LORENZ is truly proud to be supporting the acceleration of Chinese drug evaluation and approval system, and we aim to provide an integrated, world-class solution that suits the NMPA perfectly” says Wolfgang Witzel, President, LORENZ Life Sciences Group. “Together with Baosight Software, we’ll be using our global experience to ensure that the implementation of the eCTD format in China runs as smoothly as possible.”
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ offers a wide array of Regulatory Information Management solutions geared towards industry, health authorities and academia in order to support compliance globally. LORENZ' tried and tested solutions cover product registration/IDMP, submission assembly, validation and management, publishing/eCTD, regulatory planning and tracking products, as well as related services. Interoperability between LORENZ products and third party solutions, as well as the ability to automate processes, allow its customers to enhance their operational efficiencies. With over 950 paid installations in 36 countries, LORENZ has a strong worldwide customer base. The company headquarters is located in Frankfurt, Germany.
To date, LORENZ has established eCTD systems for 12 national health authorities, including the USFDA (USA), EDQM (Europe), BfArM (Germany), Health Canada (Canada), TGA (Australia), and the Thai FDA (Thailand). It is currently assisting CDE, NMPA (China) in establishing its eCTD data management system.