E2B (R3) and ISO IDMP standards unification – a new era of ICSR reporting
The global nature of the safety information exchange process requires improvements to the system for managing, collecting and transmitting Individual Case Safety Reports (ICSRs). Due to the importance of meeting the requirements set by regulatory agencies such as the European Medicines Agency (EMA) and the Food and Drug Administration (FDA), over the past two decades paper forms have shifted to electronic ICSR E2B forms whose specifications are being regularly updated by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH).
The final goal is uniformity, i.e.harmonisation and standardisation of electronic reporting and global exchange of safety information, regardless of its source or destination.
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.
Ena Bulović, MPharm / PV software validation and implementation Associate
Lašćinska cesta 40
Planinska ulica 13/2
Office: +385 1 5588 297
Pharmacovigilance: +385 1 5588 297
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Full company name
Short company name
Marti Farm Ltd. Trade and Services
Marti Farm Ltd.
Lašćinska cesta 40, HR-10000 Zagreb
Planinska ulica 13/2, HR-10000 Zagreb
a limited liability company
Commercial Court of Zagreb
HRK 20,000.00 (paid in its entirety)
Martina Diminić Smetiško, director of the
company (Representing the company
individually and independently, Responsible
person for data protection)
HR3623600001102197724 (Zagrebačka banka)
HR4324020061100628669 (Erste banka)
Full company name: Marti Farm Ltd. Trade and Services
Short company name: Marti Farm Ltd.
Headquarters: Lašćinska cesta 40, HR-10000 Zagreb
Office: Planinska ulica 13/2, HR-10000 Zagreb
Legal form: a limited liability company
Court register: Commercial Court of Zagreb
Registration number: 080751121
Share capital: HRK 20,000.00 (paid in its entirety)
Authorized representative: Martina Diminić Smetiško, director of the company (Representing the company individually and independently, Responsible person for data protection)
Bank account: HR3623600001102197724 (Zagrebačka banka), HR4324020061100628669 (Erste banka)