Global Regulatory Requirements

FDA

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 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 Standards and CDISC Standards are required for regulatory submissions to FDA.

 

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.

 

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.

The DKMA requires that data submitted for the assessment of marketing authorization applications and variations, including bioequivalence studies, be provided in CDISC format.

 

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.
 

Helpful Links
 

From FDA:

 

From PMDA: