Required by the world’s leading regulatory authorities, CDISC plays a critical role in streamlining the drug development and review process. By requiring standardized data formats, regulators such as the FDA, PMDA, and DKMA can modernize workflows, apply consistent analytical tools, and more easily identify trends, gaps, or areas of concern across submissions.
This consistency enhances the transparency, reliability, an comparability of clinicial data, supporting safer, more efficient, and more effective clinical research globally. Beyond regulatory review, CDISC standards also facilitate data reuse, sharing, and cross-study research, enabling broader insights across therapeutic areas.
As a 501(c)(3) nonprofit, CDISC brings together a global community of stakeholders, including industry, academia, and regulators, to advance data standards, ensuring that clinical research data can be leveraged effectively and collaboratively.
Are you a regulator interested in learning more about CDISC or improving the efficiency and consistency of clinical data review in your region? We would love to connect with you. Please submit your information here and we will get back to you soon.
Explore regulatory activity worldwide in the sections below.
Regulatory Requirements
Region
Regulatory Body
U.S. Food and Drug Administration
(FDA)
Summary
The U.S. Food and Drug Administration (FDA) is responsible for advancing public health by helping to speed innovations that make medical products more effective, safer, and more affordable, and by providing the public with accurate, science-based information needed to use medical products and foods safely. CDISC and the FDA have worked closely since CDISC’s inception to ensure that data standards allow regulatory reviewers to receive, process, review, and archive submissions more efficiently.
The FDA is a Platinum Member of CDISC, and CDISC Standards are required for regulatory submissions to the FDA.
✓ Regulatory Requirement
The Pharmaceuticals and Medical Devices Agency
(PMDA)
The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan works to protect and improve public health by reviewing applications for marketing approval of pharmaceuticals and medical devices, conducting safety measures, and providing relief to individuals who have suffered from adverse drug reactions.
The PMDA is a Platinum Member of CDISC, and CDISC Standards are required for regulatory submissions to the PMDA.
✓ Regulatory Requirement
Danish Medicines Agency
(DKMA)
The Danish Medicines Agency (DKMA) is responsible for ensuring that medicinal products in Denmark are safe, effective, and of high quality, and for assessing applications for marketing authorization and variations. The DKMA regulates pharmaceuticals and supports the development and availability of safe medicines for the public.
✓ Regulatory Requirement
The National Medical
Products Administration
(NMPA)
The National Medical Products Administration (NMPA) in China oversees the safety and regulation of drugs (including traditional Chinese medicines and ethnomedicines), medical devices, and cosmetics. The NMPA regulates registration, ensures compliance with standards, and manages clinical trial data submission requirements.
The NMPA has officially recognized and recommended the use of CDISC standards for electronic data submissions. The NMPA’s Center for Drug Evaluation (CDE) has committed to using CDISC standards, including SDTM and ADaM, for clinical trial data submissions. Adherence to these standards is strongly encouraged to streamline the review process, enhance data consistency, and align submissions with international regulatory expectations.
✓ Regulatory Recommendation
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