Last Updated: July 31, 2023
What’s Changing
On EMA E2B(R3) Submissions, Dose Form and Routes of Administration (RoA) data elements will follow the standard terminology maintained by the European Directorate for the Quality of Medicines & HealthCare (EDQM). This affects the following fields:
- G.k.4.r.9.1 Pharmaceutical Dose Form
- G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number
- G.k.4.r.9.2b Pharmaceutical Dose Form TermID
- G.k.4.r.10.1 Route of Administration
- G.k.4.r.10.2a Route of Administration TermID Version Date / Number
- G.k.4.r.10.2b Route of Administration TermID
- G.k.4.r.11.1 Parent Route of Administration
- G.k.4.r.11.2a Parent Route of Administration TermID Version Date / Number
- G.k.4.r.11.2b Parent Route of Administration TermID
To support this change, Vault Safety is launching a new feature to map Dose Forms and Routes of Administration records to the latest EDQM terminology. When creating EMA E2B(R3) Submissions, the data will be used to generate compliant files. When importing E2B files, EDQM terms will be mapped to your Dose Forms and Routes of Administration records.
Why is this Changing?
As of June 30, 2022, EDQM standard terminology for pharmaceutical dose forms and routes of administration will be mandatory when reporting to EudraVigilance. For more information from the EMA, refer to Mandatory use of ISO ICSR/ICH E2B(R3) and EDQM terminology for Dosage Forms (DF) and Routes of Administration (RoA).
What is the Impact?
Note: For all Vaults, mapping EDQM standard terminology to Dose Forms and Routes of Administration records during the import and export of E2B files is available automatically.
In the June 9, 2022 release of Vault Safety, the current EDQM dose forms and routes of administration terms will be loaded with standard mapping, as follows:
- Dose Form: R2_DOSAGEFORMCODE is mapped to EDQMTermID
- See Section 3 of the EMA guidance referenced in the previous section for a downloadable code-list that maps the EU ICH-E2B(R2) Dosage forms to EDQM terms.
- Routes of Administration: Terms will be mapped through text matching, for example EDQM term “Oral Use” will be mapped to “Oral”.
As EDQM terms are regularly updated, reviewing the mapping is recommended. You will be able to view and manage your company EDQM terms from Business Admin > Objects > EDQM Mappings.
Import EMA E2B(R3) Mapping
When importing an E2B file, Vault attempts to map E2B codes to EDQM codes.
Export EMA E2B(R3) Mapping Rules
When generating an E2B(R3) Submission, Vault checks if the Dose Forms and Routes of Administration on the Case are mapped to EDQM terms. Depending on whether a mapped value is found, the Vault E2B data elements are exported to the E2B(R3) file as described in the following table:
| Vault E2B Data Element | If field value maps to EDQM term, E2B exported as… | If field value does not map to EDQM term, E2B exported as… |
|---|---|---|
| G.k.4.r.9.1 Pharmaceutical Dose Form | The EDQM Name field is exported. ( dose_form__v.edqm__v.edqmname__v) |
The Name field is exported. ( dose_form__v.name__v) |
| G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number | The EDQM Version field is exported. ( dose_form__v.edqm__v.edqmversion__v) |
Not populated |
| G.k.4.r.9.2b Pharmaceutical Dose Form TermID | The EDQM Code field is exported. ( dose_form__v.edqm__v.edqmcode__v) |
Not populated |
| G.k.4.r.10.1 Route of Administration | The EDQM Name field is exported. ( patient_route_of_admin__v.edqm__v.edqmname__v) |
The Name field is exported. ( patient_route_of_admin__v.name__v) |
| G.k.4.r.10.2a Route of Administration TermID Version Date / Number | The EDQM Version field is exported. ( patient_route_of_admin__v.edqm__v.edqmversion__v) |
Not populated |
| G.k.4.r.10.2b Route of Administration TermID | The EDQM Code field is exported. ( patient_route_of_admin__v.edqm__v.edqmcode__v) |
Not populated |
| G.k.4.r.11.1 Parent Route of Administration | The EDQM Name field is exported. ( parent_route_of_admin__v.edqm__v.edqmname__v) |
The Name field is exported. ( parent_route_of_admin__v.name__v) |
| G.k.4.r.11.2a Parent Route of Administration TermID Version Date / Number | The EDQM Version field is exported. ( parent_route_of_admin__v.edqm__v.edqmversion__v) |
Not populated |
| G.k.4.r.11.2b Parent Route of Administration TermID | The EDQM Code field is exported. ( parent_route_of_admin__v.edqm__v.edqmcode__v) |
Not populated |
Was this Change Validated?
Yes, this change is validated by Veeva and follows the standard change control process, including PCR and approvals.
Does this Impact All Safety Vaults?
This update will roll out to existing Limited Release and General Release Vaults starting June 9, 2022.