To operate within a highly regulated space, the global pharma industry has been adopting various standards, such as CDISC, HL7, ISO, eCTD, ICD-9, and SNOMED to streamline the drug regulatory approval process. The more recent among these is the Identification of Medicinal Products (ISO-IDMP) – aimed at globally harmonizing formulation data to create a single unique identity for drugs sold under various brand names in different countries. In effect, this will enable drug safety tracking, accurate cross-border prescription fulfillment, and traceability while facilitating information exchange between regulatory authorities to simplify the approval process.
ISO-IDMP aims at enhancing data transparency by leveraging a common product master data model to centralize drug information across the industry. As such, it is more than likely that this new standard will become a key component of several downstream processes including clinical trials, pharmacovigilance adverse event reporting, product variations, e-prescriptions, regulatory inspections, labelling, and batch recalls.
While adopting ISO-IDMP, the first hurdle that pharma companies face is poor medicinal product data quality. Before product lifecycle information across manufacturers can be centralized, companies will need to heavily invest in structuring and reconciling data per global and local controlled vocabularies and dictionaries. This will require reengineering and revamping existing data management processes and associated IT systems to ensure integrity, quality, consistency, and reliability of the captured information—followed by extensive change management to bring it into effect.
Identifying the Right Data Management Approach
In doing so, pharma companies are taking divergent approaches with some architecting entirely new systems to support this mode of operation. Others are choosing between adopting a virtual data layer to gather and integrate information from various sources, upgrading their existing regulatory information management system (RIMS) with extended functionalities, and using a product lifecycle management (PLM) approach to collate design, production, and maintenance information.
The most favored among these is the master data management (MDM) approach that links identity and reference product data across multiple IT systems. It is flexible, easy to deploy, and provides robust data governance by establishing a centralized single source of truth (SSOT). While MDM can help businesses to achieve IDMP compliance quickly, pharma companies will also have to factor in their overall IT infrastructure, integration feasibility, product family size, data sources, and more before adopting it.
An Alternative Foundation for Unifying Drug Data
To meet IDMP standards, data from multiple sources must be collated, and significant amount of data comes from chemical, manufacturing, and control (CMC) processes. Another large chunk of highly complex information is sourced from medicinal packaged products, stored in documents and myriad systems maintained by a gamut of active pharmaceutical ingredient (API) and excipient suppliers.
For pharma companies, a viable alternative to Product Lifecycle Management (PLM) Regulatory Information Management Systems (RIMS), and Master Data Management (MDM) would be to implement an integrated CMC layer that can be used to manage all CMC related data. Considering the increasing variability of CMC data, it is imperative to focus on substance data and its governance This will grant visibility into the entire life cycle of a medicinal product, from who owns it to how it is managed and validated. As an independent function, a dedicated CMC layer can become the SSOT for substance and manufacturing related data. With this, pharma companies can hope to meet IDMP-related requirements and reduce the overall burden of identifying and managing data from numerous sources. More importantly, it can become a powerful source of transformation by setting down a semantic data foundational layer for integration of process development, commercial manufacturing, and contract manufacturing organizations (CMO) as well as cross enterprise reporting.
While most of the pharma companies are still hesitant to adopt MDM and other technologies, the alternative integrated CMC layer can be explored further to test its efficiency and viability for achieving a long term ISO-IDMP compliance strategy.
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