FDA
The US FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. CDISC and FDA have worked together closely since CDISC’s inception to ensure data standards allow regulatory reviewers to receive, process, review and archive submissions more effectively.
The FDA is a Platinum Member of CDISC Standards and CDISC Standards are required for regulatory submissions to FDA.
PMDA
The Japan PMDA continues to improve the public health and safety of Japan by reviewing applications for marketing approval of pharmaceuticals and medical devices, conducting safety measures, and providing relief to people 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.
NMPA
The China NMPA is responsible for supervising the safety of drugs (including traditional Chinese medicines and ethno-medicines), medical devices and cosmetics; regulating the registration of drugs, medical devices and cosmetics; and undertaking standards management for drugs, medical devices and cosmetics.
CDISC standards are now the preferred standards for electronic data submission in China as stipulated in the eCTD Guidance (September 2019).
Read CDISC’s official response (Chinese and English) to the NMPA request for public comments on the draft eCTD guidance.
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.