Database on pharmacovigilance and safety of medicinal products DSBase has received new functionality
The Computerized system “Database on pharmacovigilance and safety of medicinal products DSBase” has received new functionality – the ability to import and export reports on adverse reactions or lack of efficacy of drugs in electronic form in the ICH E2B (R3) format, a format that is currently a standard in the EU.
The International Conference on Harmonization (ICH) has defined E2B as the international standard for electronic transmission of adverse event reports. Since 2001, when ICH E2B (R2) was introduced, there have been several changes to the reporting requirements, which ultimately led to ICH E2B (R3). In 2019, EMA established that the use of the ISO ICSR standard, appropriately based on ICH E2B (R3), is mandatory for adverse reaction reporting.
The standard will come into effect on June 30, 2022, for all safety reports submitted to EudraVigilance, the European database for collecting adverse reactions to medicines authorised in the European Economic Area.
Until that date, the two versions, R2 and R3, will continue to coexist. After that, you will need to be prepared for the final migration, which will bring many improvements, such as:
- changes to the message format: data structure, data elements, comments and sender diagnostics, free text available for additional information, event severity criteria and assessment of correlation between drug and reactions/events;
- introduction of standard terminology: ISO (country codes, gender codes and language codes), MedDRA (used, for example, for indication and reaction/event), UCUM (unit of measurement) and ISO IDMP (drug identification);
- more effective protection of patient and consumer data thanks to the new HL7 format;
- greater respect for privacy through the introduction of zero taste;
- improved clarity of interpretation through the introduction of severity criteria at the event level.
DSBase system now allows you to use both R2 and R3 versions of the ADR exchange.
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