During the Task Force Meeting on the 13th of December, new SPOR (Substance, Product, Organization and Referential Management Services) timelines have been shared. The timelines include:
- Organisational and Referential Management Services (OMS and RMS): due to technical challenges and disaster recovery testing, the User Acceptance Testing and implementation have been delayed until April 2017. The systems will Go Live in June 2017.
- Substance Management Services (SMS): a Go Live is expected at the end of 2017.
- Implementation guidelines: the guidelines are expected to be published late 2017, early 2018.
- Product Management Services (PMS): a Go Live is expected in 2019 with enforcement late 2019.
Due to technical challenges and disaster recovery testing, the User Acceptance Testing and implementation of OMS and RMS have been delayed until April 2017. More interestingly, EMA has shared documentation on key changes, features and benefits of OMS and RMS. This information can help your company with the optimal implementation of the first parts of the EMA SPOR program that will not only be a prerequisite for IDMP, but will change a much wider scope of regulatory submissions and data management.
The updated timelines of the EMA may easily be read as a general delay, but in our view the changes that IDMP is introducing into Pharmaceutical Product Lifecycle Management are so structural that many of the issues that are being found are very understandable. Key changes include: introduction of cross-silo and cross-compliance management of master data (like organization, references and even substances). But also the depth of the IDMP data model introduces a harmonization on global scale of unprecedented scale. We feel that aligning the phasing of your IDMP objectives to the expected progress at the regulators (EMA, FDA, but also NCAs) can help you in making your regulatory way of working future proof. Please contact us for a more in-depth discussion.