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.
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:
- Study Data Standards Resources
- Data Standards Strategy FY2023 - FY2027
- Watch the video: FDA CDER Regulatory Science: Improving Drug Review with Data Standards
- Watch the video: About FDA's Data Standards Program
- Data Standards in the Drug Lifecycle
- Section 5 of Prescription Drug User Fee Act (PDUFA) VI Proposed Commitment Letter addresses “Enhancing Capacity to Support Analysis Data Standards for Product Development and Review.”
- Guidance on Providing Regulatory Submissions in Electronic Format (December 2014) requires submissions in an electronic format specified by the agency beginning 24 months from the issuance of this document.