Module 12 Presentations

Current status of SPOR

EMA is implementing the ISO IDMP standards in a phased program called SPOR. It is based on the four domains of master data in pharmaceutical regulatory processes. Below is an overview of the current status of the SPOR program.

SMS

PMS

OMS

RMS

Referential / Controlled Vocabularies

Goal

Substance Management

Product Management

Organization Management

Single source of validated organization data to be used as a reference in EU Regulatory Activities and business processes. Used in eAF for example.

Referential master data, i.e., controlled vocabularies, to describe attributes of medicinal products. Examples: dosage forms, units of measurements, Route of Administration, etc.

EU Implementation Guides (EU IG v1.0 – v2.1.1 have been released) to support MAHs with implementation and compliance to PMS

Every substance (active ingredient or excipient) has a unique ID in contrast to free-text Live – within EMA (cleansing ongoing for some substances) Partially – list of validated substances available on SPOR Portal

Description

Live – while some lists are still under review/revisions

Status

Implementation Ongoing

Live

IG v1 – Q1 2020 IG v2.1.1 – Q2 2022 Live through PLM eAF!*

Functional

Q2 2017

Q2 2017

*Live for CP products: selection of PMS data used in PLM eAF, currently not live yet for non-CPs (data in back-end available at EMA)

The Organisation for Professionals in Regulatory Affairs

Feb 1st, 2024 – TOPRA Module 12