The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has released the requirements of clinical trial data submission in the electronic common technical document (eCTD) for public review in October. CDISC standards are now the preferred standards for electronic data submission in China. The new eCTD stipulates the use of SDTM, CDISC’s standard for formatting and organizing study data, and ADaM, CDISC’s standard for data analysis, for pharmaceutical sponsors submitting datasets in clinical trial databases and related materials. Going forward, CDISC standards are the only global data standard the CDE has recommended.
The NMPA joins the US FDA and Japan PMDA in recognizing the centrality of global CDISC standards to be used for submission of clinical research study data. Requiring standardized data enables regulators to modernize the review process with a more consistent use of analysis tools to better view drug data and highlight areas of concern. CDISC standards streamline the review process and expedite approval times for more efficient and effective clinical research.
“CDISC commends the CDE and all involved in developing the eCTD, which is well-aligned with how CDISC standards are utilized globally,” said David R. Bobbitt, MSc, MBA, CDISC President and CEO. “This development represents a strengthening of the relationship between NMPA and CDISC, while supporting continued positive development of the Chinese pharmaceutical industry.”
“CDISC standards are now more than ever the global standard,” added Bobbitt.
Since 2012, the community of CDISC users in China has grown significantly as members of the Chinese CDISC Coordinating Council (C3C) promote awareness and support the implementation of CDISC standards.
CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)(3) global nonprofit charitable organization and is headquartered in Austin, Texas, with hundreds of employees, volunteers, and member organizations around the world.