SPOR is an acronym that stands for "Substance, Product, Organization, and Referential." It refers to a regulatory framework initiated by the European Medicines Agency (EMA) to establish a comprehensive database system, improve the transparency and efficiency of regulatory processes, and streamline the submission and management of information related to drugs. SPOR aims to enhance the collaboration and exchange of data between various stakeholders, including pharmaceutical companies, regulatory authorities, healthcare professionals, and patients.
The Substance aspect of SPOR focuses on creating a centralized database that contains accurate and up-to-date information about active substances used in medicinal products. This facilitates the identification, classification, and understanding of substances in different pharmaceutical products.
The Product dimension of SPOR involves the development of a unified platform that contains detailed and consistent information about authorized medicinal products, including their composition, strength, route of administration, and presentation. It aims to promote greater harmonization and standardization of product data across the European Union (EU).
The Organization aspect of SPOR entails setting up a robust data management infrastructure to ensure the quality, traceability, and integrity of data collected from different sources. This involves the establishment of data governance processes, data standards, and data exchange mechanisms.
Lastly, the Referential component of SPOR relates to the creation of a unique identification system for substances and products, known as the Substance/Product Management Services (SPMS). This system assigns and maintains unique identifiers for all substances and products, enabling accurate identification and tracking throughout the regulatory lifecycle.
Overall, SPOR represents a comprehensive regulatory framework that aims to harmonize and centralize the management of data related to substances, products, organizations, and referential information, with the ultimate goal of improving patient safety and public health within the EU.
