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.
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.
CDISC updates this page with announcements from regulatory authorities. We encourage readers to check for new announcements directly with the appropriate agency.
- Data Standards Strategy FY2018 - FY2022 (January 2018)
- Watch the video: FDA CDER Regulatory Science: Improving Drug Review with Data Standards (November 2017)
- LOINC Update (November 2017)
- Study Data Technical Conformance Guide (March 2018) specifies rules for using CDISC standards on submissions to FDA CDER and CBER.
- Watch the video: About FDA's Data Standards Program (May 2017)
- Data Standards in the Drug Lifecycle (December 2016)
- Data Standards Catalog (April 2018) specifies using CDISC Controlled Terminology, SEND, SDTM, ADaM, and Define-XML standards.
- Study Data Standards: What You Need to Know (June 2016)
- 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.”
- Electronic Submissions: The Requirement for Standardized Study Data (February 2015) - webinar presentation from Mary Ann Slack, Deputy Director, and Dr. Ron Fitzmartin, Sr. Advisor, Office of Strategic Programs, CDER, FDA.
- 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.
- FAQs in English on Electronic Study Data Submission (February 2017)
- Advanced Review with Electronic Data Promotion Group
- Notification on Practical Operations of Electronic Study Data (April 2015)
- Question and Answer Guide Regarding Notification on Practical Operations of Electronic Study Data Submissions (April 2015)
- Technical Conformance Guide on Electronic Study Data Submissions (April 2015)
- PMDA Data Standards Catalog (March 2017)
From China FDA (CFDA):
- CFDA has endorsed CDISC standards in their Clinical Trial Data Management Technology Guide (July 2016)