E2B (R3) and ISO IDMP standards unification – a new era of ICSR reporting

Growing demands for internationally harmonised standards have sparked a new wave of changes and resulted in the unification of ICH E2B (R3) and ISO IDMP (International Organization for Standardization for the Identification of Medicinal Products) standards. In addition to the improvements in data elements in E2B (R3) format, the forthcoming obligatory use of controlled vocabulary and strictly defined terminology for identifying and describing pharmaceuticals has been announced.

EMA is responsible for the ongoing implementation of ISO IDMP in the European Union (SPOR). The implementation is a four-part project based on the utilisation of specificmaster data domains:

• SMS (Substance Management Services)– data and definitions regarding unique substance identification;
• PMS (Product Management Services)–data and definitions regarding unique product identification (e.g. packaging);
• OMS (Organisations Management Services)– data regarding organisation names and locations;
• RMS (Referentials Management Services) – controlled vocabularies for describing product characteristics (e.g. route of administration).

Due to its complexity, a phased approach is considered for the implementation of SPOR, with OMS and RMS enforcement as the first step.

With everything announced in consideration, it is necessary to have a comprehensive IT system that is fully up-to-date with regard to the implementation of ICH E2B (R3) and ISO IDMP standards. Major changes in standards must be followed by adequate software development.

It is expected that,once the implementation of SPOR and the integration of ISO IDMP with E2B (R3) format is completed, data quality will improve and the planned goal of harmonisation in electronic ICSR transmission will be achieved.