A day is not far when U.S. Federal Drug Administration (FDA) and other regulatory agencies around the world make IDMP(Identification of Medicinal Products) compliance mandatory. The European Medicines Agency (EMA) has already defined a master data management strategy around substance, product, organization and referential (SPOR) that life sciences organizations must follow to curate and maintain product master data under its IDMP submission mandate.

Most major life sciences organizations have already embarked on their IDMP journey. They are now defining their data collection and preparation strategies and determining the technological ecosystem that will best serve the needs of IDMP submission in 2018 and beyond.

IDMP will not only become standard for regulatory purposes, but will also become the standard model used for systems in Pharmaceutical Information Systems, Drug Dictionaries, Clinical Decision Support, Hospital Information and Patient Information.  IDMP may be perceived just as a compliance or a pharmacovigilance reporting challenge, but it can transform the entire pharmaceutical value chain and improve operational efficiency significantly. The operational benefits of IDMP should have a positive impact on public health and safety.

How will we accomplish IDMP compliance? It really is a product master data hub or a central data repository, that will have structured and unstructured data from various source systems, and store information using an IDMP-compliant data model.  Master data integration approach will help extracting these data from multiple systems such as regulatory, labeling, safety, manufacturing, clinical and quality, integrating and augmenting them by further data in a central repository, preparing them for submission and matching the internally used vocabularies against IDMP´s controlled dictionaries.

As a central data repository, the solution enables the propagation of reliable product data into various downstream applications (e.g., CRM, ERP, etc.), thereby improving organizational efficiency and effectiveness. Understanding a 360 view of product data inside and outside of the enterprise can help optimize the supply chain process and lead to significant ROI to pharmaceutical firms.

The central repository of data should be able to

• Link product and safety information across global regulatory agencies
• Increase the biopharma industry’s signal detection capabilities to quickly identify product risk issues, including recalls
• Connect critical product information within health care systems
• Help facilitate the creation of global drug dictionaries and product dossiers

The European Medicines Agency (EMA) is implementing the ISO IDMP standards in a phased program, based on the four domains of master data in pharmaceutical regulatory processes: Substance, Product, Organization and Referential (SPOR) data.

The aim is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner.  The following set of data management services are required for SPOR framework

• Substance management service (SMS): harmonized data and definitions to uniquely identify the ingredients and materials that constitute a medicinal product;
• Product management service (PMS): harmonized data and definitions to uniquely identify a medicinal product based on regulated information (e.g. marketing authorization, packaging and medicinal information);
• Organizations management service (OMS): data comprising organization name and location address, for organizations such as marketing authorization holders, sponsors, regulatory authorities and manufacturers;
• Referentials management service (RMS): lists of terms (controlled vocabularies) to describe attributes of products, e.g. lists of dosage forms, units of measurement and routes of administration.

While the ISO IDMP standards relate to human medicinal products, SPOR applies to both human and veterinary domains.

SPOR data management services offer a number of key benefits for the regulation of medicines:

• Increased data quality and simplification of data management practices, since data will be reviewed, assessed and approved as part of the new data operating model;
• More efficient regulatory action and decision-making, thanks to improved data integrity and reliability;
• Regulatory requirements can be met more effectively, by reducing data silos and improving interoperability across EU systems;
• Operational savings and efficiencies can be achieved, as pharmaceutical companies need to supply regulatory data only once, which will be re-used across different procedures and regulators.

Expedien has several years of experience and proven methodology in building enterprise wide master data management, data governance, and data analytics solutionsfor pharmaceutical and life science companies having global operations. Expedien has been helping global pharmaceutical companies in building the IDMP compliant data platform based on cloud-based modern data management platform as a service. It not only can meet the compliance needs effectively, but also power their business operations over the long term.