EMA has published the EU IDMP Implementation Guide version 2.0. This version provides the basis for medicinal product data exchange in the EU and focuses on supporting the European medicines regulatory network to prepare for the implementation of the Product Management Service (PMS) Step 1.
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The Agency plans to deliver a PMS and a Substance Management Service (SMS) to support regulatory activities in the EU. The PMS and SMS will manage two of the four domains of substance, product, organisation and referentials (SPOR) master data in pharmaceutical regulatory processes. The SPOR services support the implementation of ISO IDMP standards in the EU.