EudraVigilance system overview
The medical dictionary for regulatory activities (MedDRA) is designed to be used in the registration, documentation and safety monitoring of products during the marketing authorisation process. Developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) (multidisciplinary topic M1), MedDRA contains highly specific, standardised medical terminology.
The dictionary is vital to ensure consistency. Its use is a regulatory requirement. MedDRA is maintained by a maintenance and support service organisation (MSSO), which keeps supporting documentation up to date with each release of MedDRA, including MedDRA training materials.
This standardisation eliminates the need for conversion from one terminology to another, thus preventing distortion of data. It guarantees consistency through the different stages of development, which facilitates effective cross-referencing.
MedDRA is used by regulatory authorities, pharmaceutical companies and clinical research organisations worldwide, and its use is a regulatory requirement of marketing-authorisation holders and applicants in the EU.
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Update: The MSSO provides updates on the inclusion of COVID-19-related terms and revisions in MedDRA for marketing authorisation holders and national competent authorities on its website: |
Subscriptions
Full details of subscription types, rates and processes can be found on the MedDRA website. Micro- and small-sized enterprises are eligible for a MedDRA fee waiver provided they:
The MedDRA fee exemption is applied at the time of EudraVigilance registration.
Sponsors of non-commercial clinical trials may also apply for a fee waiver. The conditions to qualify as non-commercial sponsor are listed in the section 'Electronic data interchange partners' under 'EudraVigilance': how to register.
Points to consider documents
The MedDRA website features ICH-endorsed guides known as points to consider documents. These are companions to the terminology and are updated in line with MedDRA changes.
They are developed and maintained by a working group consisting of regulatory and industry representatives of the EU, Japan and the United States, as well as representatives from Canada, the MSSO and Japanese Maintenance Organisation.
Version control
A newly released version of MedDRA should become the reporting version on the first Monday of the second month after it is released. To synchronise this event over the three ICH regions, the MSSO recommends midnight GMT Sunday to Monday for the switchover. All stakeholders need to adhere to this consistently, to avoid disruption to the electronic exchange of ICSRs.
MedDRA subscribers who are able to quickly update and validate their systems with each release of MedDRA should recognise that, if they submit ICSRs using the updated MedDRA version to a receiving party that has not yet switched, the transmitted ICSRs may be rejected.
Related documents
Related EU legislation
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