Regulatory Harmonization

Cross-regional alignment, IDMP, ICSR standards, and global PV reporting.

12 terms

Identification of Medicinal Products; ISO standards (IDMP) for unique identification of substances, products, and packages. Supports global exchange and regulatory reporting.

ICSR Exchange Standards

Standards for electronic exchange of ICSRs (e.g., ICH E2B(R3), HL7); ensure interoperability between MAHs and authorities.

MedDRA Versioning

MedDRA is released twice yearly (March, September). MAHs must plan upgrades and map legacy data; coding consistency affects signal detection.

VigiFlow

WHO-supported web-based system for managing and reporting ICSRs; used by many national centres and PvPI.

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Regulatory Harmonization

Cross-regional alignment, IDMP, ICSR standards, and global PV reporting.

12 terms

IDMP(IDMP)

Identification of Medicinal Products; ISO standards (IDMP) for unique identification of substances, products, and packages. Supports global exchange and regulatory reporting.

ICSR Exchange Standards

Standards for electronic exchange of ICSRs (e.g., ICH E2B(R3), HL7); ensure interoperability between MAHs and authorities.

MedDRA Versioning

MedDRA is released twice yearly (March, September). MAHs must plan upgrades and map legacy data; coding consistency affects signal detection.

VigiFlow

WHO-supported web-based system for managing and reporting ICSRs; used by many national centres and PvPI.

Safety Data Exchange Agreement(SDEA)

Agreement between partners (e.g., co-marketing) on exchange of safety data and reporting responsibilities.

Active Substance

Therapeutically active ingredient; identified in E2B and labeling. IDMP includes substance identifiers.

MedDRA Version Upgrade

Process of upgrading database and reports to new MedDRA version; impact on coding and analyses.

Legacy Data Mapping

Mapping historical data to new standard (e.g., MedDRA, E2B(R3)); ensures consistency.

SPOR(SPOR)

Substance, Product, Organisation, Referential (EU); master data for IDMP and regulatory submissions.

XEVMPD(XEVMPD)

Extended EudraVigilance Medicinal Product Dictionary; product data for EV (being replaced by SPOR).

Worldwide Unique Case ID

Identifier that can be used to link same case across submissions (e.g., to avoid duplicate at authority).

Safety Data Exchange

Exchange of safety data between partners (e.g., licensees) per SDEA.