Overview of MedDRA

In this post we will learn about the Overview of MedDRA, its history and origin, MedDRA subscriptions, contents and uses of MedDRA.

Introduction to MedDRA

MedDRA is a registered trademark belonging to the International Federation of Pharmaceutical Manufacturers Associations. MeDRA stands for Medical Dictionary for Regulatory Activities.

MedDRA is a structured vocabulary of medical and other terms relevant to the development and use of medicines in man. It was designed for use in the pharmaceutical industry/regulatory environment, ostensibly to support all stages of the regulatory process concerning human medicines.

History and Origin of MedDRA

It began life in the early 1990’s as a refinement of the, then new, dictionary developed for the UK regulatory agency’s ADROIT (Adverse Drug Reaction On-line Information Tracking) post-marketing safety database.

Developed by an international committee of regulators and industry staff, the new terminology had its first incarnation as MedDRA (Medical Dictionary for Drug Regulatory Affairs) in 1993, then being nurtured and transformed by the International Conference on Harmonization (ICH) M1 Expert Working Group into the subtly renamed MedDRA (Medical Dictionary for Regulatory Activities). Its release to an expectant public as an international ICH-approved standard took place in March 1999. By this time, its ownership had been taken over by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), with oversight by a Management Board answerable to ICH.

However, the interface with users, who purchase access rights through a system of licensing, is via the MedDRA Maintenance and Support Services Organisation (MSSO) and the corresponding, but distinct, Japanese Maintenance Organisation (JMO). The work of these bodies is undertaken on a commercial basis – currently by Northrop Grumman Mission Systems (for MSSO) and the Japanese pharmacopoeia (for JMO). The MSSO and JMO release to subscribers updated versions of MedDRA (currently) every 6 months on a CD or by Internet download (MedDRA Maintenance and Support Services, 2005).

Guidance for the use of MedDRA has been developed by the MSSO: this comprises an Introductory Guide that is provided with MedDRA to subscribers, as well as guidance on some specific contentious issues, including version control and use of MedDRA in labelling. In addition, ICH-endorsed guidelines on term selection (MedDRA R Term Selection, 2004) have been issued by a joint industry-regulators working group (‘Points to Consider’ guidelines), and this body has also published draft guidance on database searches and presentation (MedDRA R Data Retrieval and Presentation, 2004).

Another working group, under the aegis of CIOMS, is developing standardized pharmacovigilance search strategies.

MedDRA Subscriptions

MedDRA is available only on payment of a subscription to the MSSO or JMO, although this is free for regulatory authorities. 

The usual type of subscription involves the ‘core service’ which provides for use throughout a company and its wholly owned subsidiaries. The core service supplies the subscribing company with two updated versions of MedDRA each year, together with the facility to request up to 100 changes per month to MedDRA. 

Changes that are accepted by the MSSO are posted on their website and are available in the next version of the terminology. The Core Service subscriptions are based on the annual revenue of the company, as published in the annual report. The annual subscription charges in 2005 range from $3825 for a company with revenue under $1 million to $92 292 for a company with more than $5 billion annual revenue. It does not take a mathematical expert to appreciate that there is some significant disproportion at play here!

This completes our discussion on Overview of MedDRA. We hope this gives you flavour of the Overview of MedDRA and how it is used in pharmacovigilance.

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