Welcome to the ICH MedDRA website
In the late 1990s, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) developed MedDRA, a rich and highly specific standardised medical terminology to facilitate sharing of regulatory information internationally for medical products used by humans. ICH’s powerful tool, MedDRA is available to all for use in the registration, documentation and safety monitoring of medical products both before and after a product has been authorised for sale. Products covered by the scope of MedDRA include pharmaceuticals, biologics, vaccines and drug-device combination products. Today, its growing use worldwide by regulatory authorities, pharmaceutical companies, clinical research organisations and health care professionals allows better global protection of patient health.
Governance ensures the integrity of MedDRA
ICH has created a governance structure to nurture and protect the integrity of MedDRA. The ICH MedDRA Management Board, appointed by the ICH Steering Committee, has overall responsibility for the direction of MedDRA, and oversees all the activities of the ICH MedDRA Maintenance and Support Services Organization (MSSO) which is tasked to maintain, develop and distribute MedDRA. ICH has also established a Japanese Maintenance Organization (JMO), which works in close collaboration with MSSO, to support users in Japan.
In addition to the original English master and Japanese translation, MedDRA has been translated and is maintained in the following languages: Chinese, Czech, Dutch, French, German, Hungarian, Italian, Portuguese and Spanish. Each MedDRA term has an associated 8-digit numerical code which remains the same irrespective of the language. Multiple languages allow a wide number of users to operate in their native language which promotes accuracy and precision in assigning codes. This interoperability is very powerful and allows easy sharing of data internationally.
Affordable and free for government regulators
A MedDRA subscription is available without charge to all regulators worldwide, while paid subscriptions are on a sliding scale linked to annual turnover of companies. Academics and health care providers can also access MedDRA from MSSO at no cost and from JMO at a nominal cost.
Free training for Users
To further facilitate MedDRA implementation and correct use, free training is offered to all subscribers on a wide range of topics and in different formats (face-to-face training, online sessions - webinars, and recorded videocasts). The MSSO staff also offers training in a variety of languages: English, French, Spanish, German and Chinese. The JMO staff offers training in Japanese.
Free support tools
Under the governance of the ICH MedDRA Management Board, MedDRA is continuously enhanced to meet the evolving needs of its users worldwide. After use for more than a decade, MedDRA has a wealth of experience around it with a strong development and maintenance programme to keep it current and numerous tools to support its users.
The current ICH M1 Points to Consider Working Group develops and maintains two documents on the use of MedDRA for data entry (coding) and data retrieval/analysis. The latter includes guide on the use of Standardised MedDRA Queries (SMQs), as powerful tools for assisting with safety signal detection. Both documents are updated twice a year, with every MedDRA release, and are available in English and Japanese.
Additional essential supporting documentation is also provided by the ICH to all MedDRA subscribers as part of their subscription. Included are Introductory Guides on MedDRA and SMQs, and guide on the use of the MedDRA electronic files with explanations of the file structure. These documents are updated by the MSSO with every MedDRA release and are available in all MedDRA languages.
The ICH tasked the MSSO to develop a variety of computer tools to help users navigate MedDRA (browser tools) and assess the impact of any changes in users’ data due to version changes of MedDRA (MVAT tool). MSSO has also developed a Change Request tool (WebCR tool) to facilitate user submission of proposed changes to MedDRA.
Direct support for Users
Subscribers can have direct support through Help Desk services. Annual MedDRA User Group meetings are also organised in Europe, USA and China by the MSSO and in Japan by the JMO. This forum provides an opportunity for users to network and exchange best practices, lessons learnt, challenges in implementation and potential MedDRA developments.
We hope that this summary provides you with a general understanding of how ICH ensures that this ICH terminology is developed to meet users’ needs and that appropriate guidance, training and support tools are available to facilitate its access and proper implementation.