As the pharmaceutical industry has become increasingly global and complex, policy makers worldwide have proposed new regulations designed to improve patient safety, enable greater transparency as well as to better secure the supply chain.
Identification of Medicinal Products (IDMP) is an international pharmacovigilance and patient safety initiative addressing this need for global identification of regulated pharmaceutical products during their lifecycle. The objective is to harmonize the definition of products and to facilitate the exchange of medicinal product data globally between regulators and manufacturers, as well as suppliers and distributors.
IDMP compliance requires that the information sent to regulatory agencies be in a specific format for each language and country, and tagged with an International Organization for Standardization (ISO) code.
Dassault Systèmes believes that IDMP is more than just a pharmacovigilance mandatory requirement, but also a significant opportunity for digital continuity for pharmaceutical companies which would provide competitive advantage.
To achieve this, digital continuity requires a platform capable of providing the following:
- Medicinal Product Structure Management (MPSM), based on IDMP requirements
- Full specification management
- End-to-End change control (including impact analysis and involvement of appropriate subject matter experts)
- Regulatory intelligence capabilities