Posted Mon, 01 Jul 2024 15:33:32 GMT by Johanna Bracken
When using IRIS, it appears that the section on Scientific information – drop down menus do not accommodate sufficiently for sPIP application as certain information remains unknown based on the nature of stepwise PIP process e.g. potential controls are unknown at this time but drop down menu only allows for set selection of controls to be chosen and does not have category for ‘unknown’
Planned submission date is also undetermined as per nature of sPIP but calendar date needs to be entered.
It seems that for an sPIP application,  there are challenges posed by the requirement to 'Please provide all details on each proposed study/measure to be included in the new PIP Decision. Please provide advice on how to progress with an sPIP application when data may be deficient at time of submission. Thank you.
 
Posted Tue, 02 Jul 2024 06:29:11 GMT by Paolo Tomasi EMA
Information on the planned date of submission of the MAA will be recorded in the RPI, so that it can be kept up to date for all submissions based on RPIs or Regulatory entitlements. EMA intends to track submission pipeline information for pre-submission products in early development via the RPI record. The information is about the forecasted date of submission of the next Marketing Authorization Application, eligibility basis and legal basis of the application. 

The functionalities are currently in development, and are expected to be available later in the year. Industry owners of RPIs will be able to update the information at any time in the RPI, using the Industry portal; in addition, at every new submission based on an existing RPI or regulatory entitlement (e.g., Paediatric, Orphan, Scientific Advice and PRIME submissions) applicants will be offered the possibility to update this information in the RPI, or confirm its validity.

The information provided in the RPI is not binding and can be changed at any time by the RPI owner. The same functionality will also be available to update the Product Contact for the RPI. 

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