Medical Dictionary for Regulatory Activities

Medical Dictionary for Regulatory Activities
Name	Medical Dictionary for Regulatory Activities
Acronym	MedDRA
Launched	1999
Owner	International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Status	Active

Contents

Medical Dictionary for Regulatory Activities

The Medical Dictionary for Regulatory Activities is a standardized clinical terminology used in pharmacovigilance, clinical trials, drug safety, adverse event reporting, and regulatory affairs. It provides a common language enabling interoperability among stakeholders such as the European Medicines Agency, Food and Drug Administration, Pharmaceutical Research and Manufacturers of America, World Health Organization, and national competent authorities. The terminology supports data aggregation, signal detection, and regulatory decision-making across regions including United States, European Union, Japan, China, and India.

Introduction

MedDRA is a multiaxial, hierarchical medical terminology designed for coding adverse events, indications, and medical history in submissions to authorities like the European Medicines Agency, Food and Drug Administration, Health Canada, Pharmaceuticals and Medical Devices Agency of Japan, and the Therapeutic Goods Administration of Australia. It facilitates harmonization among stakeholders such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, World Health Organization, Council of Europe, United Kingdom Medicines and Healthcare products Regulatory Agency, and industry consortia like the International Generic and Biosimilar Medicines Association. MedDRA is used alongside classification systems such as the International Classification of Diseases and terminologies like the Systematized Nomenclature of Medicine.

Development began in the late 1990s through collaborative efforts among organizations including the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, the World Health Organization, the European Federation of Pharmaceutical Industries and Associations, and national regulators such as the Food and Drug Administration and Pharmaceuticals and Medical Devices Agency. The first release coordinated inputs from stakeholders like GlaxoSmithKline, Pfizer, AstraZeneca, Novartis, Roche, and academic partners at institutions such as Harvard University and University of Oxford. Iterative updates responded to feedback from meetings at venues including the International Conference on Harmonisation and workshops hosted by the World Health Organization Collaborating Centre. Subsequent versioning reflects changes driven by pharmacovigilance incidents involving products regulated by entities like the European Medicines Agency and Health Canada.

MedDRA is organized into a five-level hierarchical structure comprising System Organ Class, High Level Group Term, High Level Term, Preferred Term, and Lowest Level Term. Its content covers adverse reactions, procedural events, laboratory observations, and product complaints relevant to submissions to authorities such as the Food and Drug Administration and European Medicines Agency. The dictionary contains thousands of preferred terms that map to standardized regulatory concepts used by sponsors like Johnson & Johnson, Merck, Bayer, and Sanofi. Cross-mapping is often performed between MedDRA and taxonomies such as the International Classification of Diseases, SNOMED CT, and the Unified Medical Language System to support data exchange in systems employed by hospitals like Mayo Clinic, Cleveland Clinic, and research centers such as Johns Hopkins University.

Governance is overseen by an organization that coordinates maintenance, release schedules, and change requests from stakeholders including regulators like the Food and Drug Administration and industry groups such as the Pharmaceutical Research and Manufacturers of America. The rules for term creation, modification, and obsolescence are informed by panels with representatives from companies like GlaxoSmithKline, Pfizer, Novartis, regulatory authorities such as the European Medicines Agency, and global health agencies including the World Health Organization. Biennial release processes align with pharmacovigilance requirements set by entities like the Council of Europe and national agencies such as Health Canada. Change management involves expert committees and public consultation similar to procedures used by bodies such as the International Organization for Standardization.

Regulatory submissions to authorities such as the Food and Drug Administration, European Medicines Agency, Health Canada, and Therapeutic Goods Administration use MedDRA-coded datasets for adverse event listings, periodic safety update reports, and signal detection. Signal management workflows at organizations like the World Health Organization's Uppsala Monitoring Centre, the European Medicines Agency, and national pharmacovigilance centers rely on MedDRA for aggregation and mining alongside statistical tools developed by academic centers including Imperial College London and Stanford University. Clinical trial data management systems from vendors such as Oracle Corporation, Veeva Systems, and Medidata Solutions integrate MedDRA to ensure consistency in submissions to regulatory agencies like the Food and Drug Administration.

MedDRA adoption has expanded across regions including North America, Europe, Asia, Africa, and South America with licensing and translation efforts involving institutions such as the World Health Organization and national authorities like Health Canada and the Pharmaceuticals and Medical Devices Agency. Its use has influenced post-marketing surveillance practices at multinational companies such as Roche and Sanofi, and harmonized adverse event reporting templates employed by consortia like the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. The terminology supports multinational pharmacovigilance studies conducted by collaborations among universities and regulators, echoing standardization initiatives seen in projects like the Clinical Data Interchange Standards Consortium.

Critics point to licensing costs, maintenance overhead, and complexity that affect smaller organizations, academic researchers at institutions such as University of California, San Francisco and public health agencies in countries like Kenya and Brazil. Interoperability challenges arise when mapping to International Classification of Diseases or SNOMED CT, leading to potential inconsistencies noted by regulatory reviewers at agencies including the European Medicines Agency and Food and Drug Administration. Language translation and context-specific term usage have been raised in stakeholder meetings involving the World Health Organization and regional regulators, prompting calls for enhanced governance models similar to reforms at institutions like the International Organization for Standardization.

Category:Medical terminology