1. Release Notes—What's New
  2. What's New
  3. Enhancements to Oracle Argus Safety
  4. Regulation updates
  5. EMA Regulation updates

EMA Regulation updates

Summary

International transfer of personal (health) data in ICSRs originating from EudraVigilance (EV) to third countries (Enhancement 34909010)

Description

ICSRs originating from the EEA countries that are transferred in paper or E2B format to third countries (except for the countries listed by European Commission Data Protection Adequacy decisions) need to handle data as per the EMA special instructions.

This is applicable to all ICSRs originating from EEA countries that includes clinical trials and post-marketed and not restricted to ICSRs downloaded from EVWEB.

In the early months of 2022, EMA was notified that certain marketing authorization holders, while accessing EudraVigilance, had transferred personal health data from EV to third countries without appropriately redacting the personal information.

As per the European Data Protection Supervisor (EDPS) clarification, MAHs act as the controllers for personal data processing, and must follow the EMA regulation, while transferring personal data to non-EU countries.

When reporting ICSRs originating from EV to foreign governments and U.S. authorities, MAHs are required to follow the redacting guidelines to ensure compliance that personal health data cannot be re-identified through location data (such as country, city, postcode, hospital names, etc.) combined with medical details (such as ADRs, laboratory data and medical history).

As per the EMA special instructions, EU can be utilized in place of ISO country codes. Case narratives and comments element must undergo risk assessment to ensure adherence to the GDPR data minimization principles.

Modifications are made in Argus Safety to update the report mappings in accordance with EMA special instructions for EEA ICSRs transmitted to third countries.

Console changes
  • As per EMA, there are few countries that provide adequate protection for EU data. Such countries are identified in Argus by providing a new attribute EU Data Protection in the Countries flexible code list. This attribute is set to 1 for these countries.

    For details on the countries that provide adequate protection for EU data, refer to the ArgusSafety843_CaseForm_Console_Updates_Summary.xls.

  • In the Reporting Destination > Report tab, a new check box Apply EMA Special Rules is introduced to enable the EMA special instruction rules at the reporting destination level.
    • By default, Apply EMA Special Rules is unchecked. When unchecked, the existing logic remains in effect and special rules are not executed.
    • The Apply EMA Special Rule option is a hyperlink. When clicked, it opens a help window that displays the impacted profiles, elements, and rule descriptions.

    When the reporting destination is copied to create a new reporting destination, the settings pertaining to the special rule check box are copied.

    Note:

    After you upgrade to the Argus 8.4.3 release, you must update the special rule check box for the impacted profiles.
Interchange mapping updates
When the EMA Special Rules check box is checked for a reporting destination, the system executes additional mapping logic on data elements that are listed below, when the following criteria is met.
  • The reports are scheduled with Protect Confidentiality set at report level.
  • One of the Reporter Country belongs to EU country.
  • Reporting destination receiver country does not belong to EU countries or EEA Approved Country.

E2B(R2) elements

The ISO 3166 country code is replaced with EU for the following elements:
  • Safety Report Unique Identifier [A.1.0.1]
  • Reporter country [A.2.1.3]
  • Primary source country [A.1.1]
  • Occur country [A.1.2]
  • Obtain Drug Country [B.4.k.2.3]
  • Drug authorization country [B.4.k.4.2]
The following elements are not transmitted:
  • Patient medical Comments [B.1.10.7.1g]
  • Parent medical comments [B.1.7.1g]
  • Relevant Medical History and Concurrent Conditions [B.1.7.2]
  • Additional Information on Drug [B.4.k.19]
  • Reporter's Comments [B.5.2]
  • Sender's Comments [B.5.4]

E2B(R3) elements:

The ISO 3166 country code is replaced with EU for the following elements:
  • Message Identifier [N.2. r.1]
  • Safety Report Unique Identifier [C.1.1]
  • Reporter country [C.2. r.3]
  • Drug Authorization Country [G.k.3.2]
  • Event Occurred [E.i.9]
  • Obtain Drug Country [G.k.2.4]
The following elements are not transmitted:
  • Patient medical Comments [D.7.1.r.5]
  • Parent medical Comments [D.10.7.1.r.5]
  • Relevant Medical History and Concurrent Conditions [D.7.2]
  • Additional Information on Drug [G.k.11]
  • Reporter's Comments [H.2]
  • Sender's Comments [H.4]
  • Lab Comments [F.r.6]

Mapping changes are made for the following profiles:

  • ICH-ICSR V2.1 MESSAGE TEMPLATE
  • ICH-ICSR V2.1 MESSAGE TEMPLATE - EMA
  • ICH-ICSR V2.1 MESSAGE TEMPLATE - FDA
  • ICH-ICSR V2.2 MESSAGE TEMPLATE - FDA
  • ICH-ICSR V3.0 MESSAGE TEMPLATE
  • ICH-ICSR V3.0 MESSAGE TEMPLATE - FAERS
  • ICH-ICSR V3.0 MESSAGE TEMPLATE - EMA
  • ICH-ICSR V3.0 MESSAGE TEMPLATE – NMPA
  • ICH-ICSR V3.0 MESSAGE TEMPLATE – EVAERS
For more details on mapping changes, refer to the following mapping documents:
  • ArgusInterchange843_E2B (R2) 2.1 Export Mappings.xlsx
  • ArgusInterchange843_E2B (R2) 2.2 Export Mappings.xlsx
  • ArgusInterchange843_E2B (R3) Export Mappings.xlsx.

Note:

Apply EMA Special Rules does not impact the following reports:
  • CDRH EMDR V1.0 MESSAGE TEMPLATE
  • EC-MIR MESSAGE TEMPLATE
  • PMDA-DEVICE MESSAGE TEMPLATE
  • ICH-ICSR V3.0 MESSAGE TEMPLATE – MFDS
  • Paper reports other than CIOMS
Mapping updates to CIOMS report
Fields Name Description
25b. NAME AND ADDRESS OF REPORTER No change is made to print country information as Name and Address withheld is displayed when Protect Confidentiality is set for the reporter at report level.
23. OTHER RELEVANT HISTORY

Notes: Information Withheld is printed instead of Notes.

Notes In Other Relevant History From/To Dates, Type of History, Description are printed as per the existing functionality.
7 + 13 DESCRIBE REACTION(S) (including relevant tests/lab data)

Based on the selection in the Reporting Destination > Reports tab, case comments and company comments are printed as: Case Comment: Information Withheld and Company Comment: Information Withheld respectively.

Note: In Event Verbatim > case narratives, lab date, results and normal high/low is printed as per the existing functionality.

Analysis of Similar Events is printed as is.
1a. Country When the Country of Incidence is associated with EEA=1 in the Country code list, then European Union is printed.
26 Remarks

Medically Confirmed: information is printed as per the existing logic.

Patient ID: Information Withheld is printed.

Study ID: Information is printed as per the existing logic.

Center ID: Information is printed as per the existing logic.

WWI: Information Withheld is printed.

Report Comments information is printed as per the existing logic.

Case References: Information Withheld is printed.

For more details about the mapping changes, refer to the CIOMS mapping documents.

Parent topic: Regulation updates