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Navigating Pharmaceutical Data Management: ISO IDMP with RIMS and eDMS

Written by Andrea Bartolomei | Jul 2, 2024 8:00:00 AM

One of the major challenges that pharmaceutical companies will face in the coming years is the updating and maintenance of company databases with correct and complete information in accordance with the new ISO IDMP requirements. This is necessary to obtain marketing authorization for their products in various international markets or to comply with the requirements of various regulatory bodies (primarily the EMA) for already authorized products. The goal set by the EMA is to improve the quality and reliability of medicinal product data through the SPOR (Substance, Product, Organization, Referential) project, which involves the adoption of the international IDMP (Identification of Medicinal Products) standards developed by the International Organization for Standardization (ISO). Other regulatory bodies are considering adopting these standards, including Swiss authorities, who are prioritizing the project with potential alignment to some of the EMA requirements, and US and Japanese authorities, who are part of the Global IDMP Working Group and are therefore likely to align with these standards soon.  This translates into the need for various companies to promptly undertake a review of internal processes that allow for the standardized and consistent collection and management of information.