IDMP in Brief:
ISO IDMP (Identification of Medicinal Products ISO: 11615) is a complex HL7-compliant standard for the electronic identification and exchange of regulated medical product information. IDMP is supported by five separate but interrelated ISO standards which will provide the basis for the unique identification of medicinal products worldwide. The EMA and the FDA, as well as other regulatory agencies, have worked together on this international standard.
IDMP is an effort to improve the reporting and tracking of patient safety issues on an international level. This will be achieved in part by standardizing how medicinal products are identified by requiring unique international identifiers for products and substances. The product and substance information is encoded using HL7 and ISO-compliant techniques in XML. The most successful implementation of this strategy to date is the FDA's SPL initiative. (i4i is the world's leading manufacturer of software for the authoring and publishing of SPL data.)
The Challenges: Implications for the Pharmaceutical Industry
IDMP compliance will impact the preparation and planning of submissions and maintenance of data on a company-wide scale: from manufacturing data and structured substance information to registration information. A core challenge of an IDMP implementation plan is determining where the authoritative data exists today and where it will exist in the future.
Data in Your Documents: the i4i Application for IDMP
i4i's IDMP tools focus on the data and clinical particulars found in your existing submission documents. Our tools use your medicinal product documents: CMC, labeling, etc., as a golden source for IDMP data. We will help you identify, review, extract, validate, and publish the data and clinical particulars found in your unstructured content. This process creates persistent data, instilling structure so that the data in your documents can be readily found and updated on demand. Managing this data in your documents moving forward will be key to remaining consistent, compliant, and accurate in your submissions - and our IDMP tools are designed to ensure this happens.
Our IDMP offering combines our new analytics document data service and ALiCE, which enhances compliance by delivering intelligent content authoring, reuse, repurposing, and tracking across your organization as products and regulations evolve.
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