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MedDRA Terminology - a brief overview and update

MedDRA Terminology - a brief overview and update. Andrea Neal, DMD, MPH Office of Post-Marketing Drug Risk Assessment Center for Drug Evaluation and Research. MedDRA Terminology. ICH Harmonized Medical Terminology for Regulatory Purposes An International Medical Terminology (IMT)

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MedDRA Terminology - a brief overview and update

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  1. MedDRA Terminology - a brief overview and update Andrea Neal, DMD, MPH Office of Post-Marketing Drug Risk Assessment Center for Drug Evaluation and Research

  2. MedDRA Terminology • ICH Harmonized Medical Terminology for Regulatory Purposes • An International Medical Terminology (IMT) • Multi-axial terminology built upon 5-level Hierarchical Structure

  3. Current Situation Makes Exchange of Information Difficult • Research Institutions and Practitioners • create multiple submissions in various terminologies • Industry / CROs • receive reports in various terminologies • FDA report evaluators • receive submissions coded in various terminologies

  4. Benefits of the Standard Terminology • Improve regulatory communications between all involved parties • Facilitate consistent coding and decrease information loss, thereby enhancing quality review • Decrease time spent by reviewers on data normalization (cont…)

  5. Benefits of the Standard Terminology • Decrease submission time for INDs/NDAs • Improve product labeling • Facilitate shift to electronic submissions - pre & post • Improve epidemiological study on global scale

  6. ICH guiding principles • Build from existing terminologies to maximize compatibility • Focus on international community needs • Ensure worldwide use through collaboration and participation in development • Ensure mechanisms and structures to enable translation into many languages • Ensure long-term maintenance

  7. Terminologies Included • MCA Medical Terminology • COSTART (5th ed.) • WHO-ART (96:4) • J-ART (1996) • ICD-9 • ICD-9-CM (4th revision) • HARTS (release 2.2)

  8. MedDRA Terminology • Progression from version 1.0 to version 2.0 • Same 5-level hierarchical structure • Thousands of additional terms • Complete re-write of several SOCs

  9. Scope of MedDRA • Diseases • Diagnoses • Signs • Symptoms (cont…..)

  10. Scope of MedDRA (cont.) • Therapeutic indications • Investigation names & qualitative results • Medical & surgical procedures • Medical, social, family history

  11. Scope of possible, future expansion: • drug /product terminology • equipment / device / diagnostic prod. • study design • patient demographic terms • device failure • population qualifiers (i.e. rare, frequent) • descriptors of severity

  12. Use throughout regulatory cycle • Clinical Studies • Adverse Event/Reaction Reporting • Regulatory Submissions • Regulated Product Information

  13. Adverse Event Reporting in CDER - changing environment • Rapidly growing # reports - 200,000 + / yr. • Faster review cycle • More complex pharmaceuticals • Aging population using more pharmaceuticals

  14. MedDRA Implementation: FDA • MedDRA implemented Nov. ‘97 • Launch of AERS (Adverse Event Reporting System) - January ‘98 • All Adverse Event Reports entered to database coded in MedDRA

  15. ANPRM Issued 11/5/98 • For Electronic ADR Reporting • To Implement: • ICH M1 (MedDRA) • ICH M2 (Electronic Transmission Standards) • ICH E2B (Safety Report Data Elements) • Goal of Paperless Environment by 2002

  16. ANPRM (cont.) • Comments specifically solicited regarding: • whether exemptions should be granted • if so, their basis • cost benefits / cost burdens • timeframes for implementing requirement • Comments received and being considered

  17. Next Steps • Continue implementation on post-market side • Prepare NPRM for Electronic ADR Reporting • Lend CDER/CBER experience to the implementation of MedDRA on pre-market processes

  18. Web Sites to Check Out • http://www.fda.gov • http://www.fda.gov/cder • http://www.fda.gov/cder/aers/index.htm • http://www.fda.gov/medwatch • http://www.meddramsso.com

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