News and updates from the SPOR Task Force Meeting held on 10 March 2017. As previously communicated, OMS and RMS UAT has been kicked off this week and is still expected to go live for the end of May 2017 and the PMS and SMS go-live is still targeted for mid-2019. The good news is this: new efforts are now in place to build out timelines related to the various approval/project steps and the development and finalization of the EU guidance. The intended benefit of this more formalized project management approach is to ensure that the guidances are developed in a way that meets the requirements in terms of technical components and support for overall processes.
In all likelihood, there will be interim releases of PMS and SMS data for mapping purposes, yet it still appears that actually being able to submit a new or updated record in those systems will be in mid-2019. Nearer term impacts are on the eApplication Form (eAF), xEVMPD and the new portal CESSP.
Also in play are the Iteration 1 fields. Some progress has been made but discussions continue. By some estimates, there may be as many as 120 data elements for Iteration 1 as compared to the current working estimate of 79. However, some key agreements are:
- Marketing Status and Risk of Shortage of Supply will not be included
- Manufacturer/Establishment information will be included (subject to ROG agreement on support for the Variations business case)
- Indication data will be limited to the Indication Text and Indication coding (as per xEVMPD)
What should you be doing now?
- Stay on top of the evolving iteration 1 fields as they may impact your current assessments related to data source analyses and strategies for collecting this data. “Over-collecting” would be a smart move to ensure you are not scrambling at the last minute.
- Keep watching the implementation guide development project. A draft of some technical aspects has been provided to CEN to determine if copyright issues will exist. This is to be followed up by a formal request from the EMA’s legal team for assessment as to whether it falls within the ‘fair use policy’ or whether a charge would apply. Also, the draft EU guide has been reviewed within the P-subgroup and is a good start, at least on the technical side but there will need to be a lot of effort put into developing the process parts of the guide and linking that to the technical description of fields.