To know what is SPOR, we need to understand what is IDMP at the outset. Identification of Medicinal Products (IDMP) is a set of five ISO standards introduced to identify and describe medicinal products. The aim of IDMP is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner. The use of these standards is a regulatory requirement as they are mandated by the EU legislation (Commission Implementing Regulation (EU) No 520/2012 [articles 25 and 26])
While the most important need for IDMP is to enhance Pharmacovigilance, speed of response, electronic prescription of medicines in the EU, controlling the authenticity of medicines, identifying substances across regions, and addressing shortages stand as other essential objectives. IDMP enables faster identification and recalls, improves the communication between supply chain and Regulatory affairs, and facilitates process efficiencies in Regulatory activities.
What is SPOR?
The European Medicines Agency (EMA) is implementing the ISO IDMP standards for the identification of medicinal products in a phased programme, based on the four domains of master data in pharmaceutical regulatory processes: Substance, Product, Organisation and Referential (SPOR) data.
EMA is delivering four SPOR data management services for the centralised management of master data that comply with the ISO IDMP standards. SPOR's objective is to deliver high-quality data management services for Substances, Products, Organizations, and Referentials.
The SPOR Data Management Services Include
- Substance Management Services (SMS)
- Product Management Services (PMS)
- Organizations Management Services (OMS)
- Referential Management Services (RMS)
Need for SPOR
| Need for IDMP SPOR Emerged Due To… | Results of Missing Data Standardization… |
| Scattered data across organizations, applications, databases and the industry | Inconsistent data, reduced data quality and data duplication |
| Names used for organizations differ in various departments | Inefficiencies relating to correcting data and investigating data discrepancies |
| Different names for substances used across different regions in the Europe and globally | Manual intervention required to resolve data issues |
| Data often entered manually | Slower decision-making based on inaccurate information |
SPOR Implementation
The European Medicines Agency (EMA) is aiming at implementing ISO IDMP standards in phases through four projects, i.e., SPOR Data Services. In addition, the European Commission, European Union Network Data Board (EUNDB) and the EU ISO IDMP Task Force (a.k.a. SPOR Task Force) recommended the phased approach of implementing ISO IDMP. The first phase includes the implementation of RMS and OMS, which lay foundation for the subsequent implementation of SMS and PMS.
EMA will set up ISO IDMP compliant business services for the central management of data in all SPOR areas. These comprises data management services for:
- Substance data: Consistent data and definitions to distinctively identify the ingredients and materials that form a medicinal product
- Product data: Standardized data and descriptions to exclusively identify a medicinal product based on regulations available (e.g., marketing authorization, packaging, and medicinal product information, etc.)
- Organization data: It comprises data of name, location, address, etc. for MAH, sponsors, Regulatory authority, manufacturers, and more.
- Referential data: Lists of terms (controlled vocabularies) used to describe attributes of products, e.g., units of measurement, lists of dosage forms, route of administration, etc.
SPOR applies to both Human and Veterinary domains and aims to implement the Identification of Medicinal Products (IDMP) standards developed by the International Organization for Standardization (ISO). Once EMA implements the SPOR programme phases and exploits opportunities for integrating the SPOR services with other systems, SPOR's advantage will increase predominantly.
SPOR is incepted to prove beneficiary to organizations and public. The key benefits include
- Easier decision making with improved data integrity and reliability
- Enhanced data quality and clarity in data management procedure with data examined, assessed, and approved, as part of a new data operating model
- Effective data standardization with reduced data silos and enhanced interoperability across EU systems
- Operational efficiency and cost-savings with decreased data redundancy
The submission and maintenance of data on authorised human medicines is already mandatory since July 2012. This is based on a format called Extended EudraVigilance Product Report Message (xEVPRM), which will be replaced by the ISO IDMP compatible format. For implementing IDMP, the EMA has already published a roadmap to master data management in April 2015. The incorporation of SPOR data stored around multiple systems into a specific MDM solution will enable the establishment of high-quality, coherent, and consistent data for stakeholders. SPOR master data solution increases decision making of enterprises offering a crystal-clear recognition of the benefits linked to businesses.
SPOR’s full benefits will get more visibility once implemented by EMA in phases and in ISO IDMP compatible formats.
To know more about SPOR and how it help for IDMP preparation, reach out to Freyr at sales@freyrsolutions.com.