The EDQM standard terms will be mandatory starting from 30 June 2022 for the indication of dosage forms and routes of administration in pharmacovigilance reports. Here’s the news.
EDQM standard terms: what they are
The EDMQ standard terms are identifying terminology established by the European Directorate for the Quality of Medicines & Healthcare at the request of the European Commission.
These terms identify the routes of administration and dosage forms, but also units of presentation and containers, closures and delivery devices for products intended for both human and veterinary use.
They are used in adverse reaction reports, but also in marketing authorisations, electronic communications, drug labels and Summaries of Product Characteristics (SmPCs), the document in which information about the medicinal product is collected such as pharmaceutical form, parameters clinical and pharmacological properties.
The terms are more than 900 in 35 languages. They are collected in the Standard Terms Database. Here it is also possible to view the changes made to the terms, an explanation of the different possible states of a standard term, technical information such as object identifiers (OIDs) for the different lists of deadlines, ongoing requests and the latest decisions of the Commission for the European Pharmacopoeia.
Access to the database is available free of charge for users registered on the EDQM Publications registration site.
EDQM standard terms: what changes
From 30 June 2022 it will be mandatory to use the EDQM standard terms for the indication of Dosage Forms (DF) and Route of Administration (RoA) of drugs in the ICSR(s).
The European Directorate for the Quality of Medicines & Healthcare (EDQM) will periodically issue updates to the terms. As soon as these are approved, they will be uploaded to the SPOR RMS portal.
Every Sunday, EudraVigilance, the European database for pharmacovigilance reporting, will synchronize with SPOR RMS to update its terms.
For companies that carry out pharmacovigilance activities, it is therefore necessary to keep the EDQM terms constantly updated in their safety database. The risk is to run into submission failures.
What changed in SafetyDrugs
Max Application, the software house developer of SafetyDrugs, has promptly worked to implement the EDMQ standard terms in the safety database and to make some improvements that are useful for the user.
First of all, the fields dedicated to the Route of Administration and Dosage forms have been converted from free text fields to list of values. The user can now simply choose the right option without worrying about entering it correctly. However, the possibility of manually entering the values remained.
Alerts have also been added, both in the import phase and in the case management phase, to signal the presence of any old TERMID codes that are no longer in use or EDQM codes that are invalid or out of date.
Finally, a new table has been inserted which lists all the EDQM codes, both valid and not, with an indication of the relative class they belong to. Furthermore, after adjusting the tables relating to the Route of Administration and the Formulation, a mapping was created between the old TERMIDs and the new EDQM codes. In this way the user can update the codes based on the periodic updates released by the institution.