PIP submission in EMA IRIS Portal, includes questions on submission pipeline ?

Isha Arora
Posted Tue, 25 Jun 2024 08:06:20 GMT by Isha Arora Dr.

For an upcoming PIP submission in IRIS, the second category is 'Updated Information on RPI' and there are a series of questions on the submission pipeline - please attached screenshot.
Can you please explain how those questions are even related to RPI scientific data in IRIS, and why those questions are displayed as part of a PIP submission ? 
We believe that this a total separate topic (submission predictability information) which should not be part of a PIP submission.
If you can please also clarify how this data is collected, tracked, used and communicated further within different stakeholders?


 

Screenshot 2024-06-25 100600.png (128.1 KB)
Answer
Paolo Tomasi
Posted Wed, 26 Jun 2024 11:14:52 GMT by Paolo Tomasi EMA
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. 

You must be signed in to post in this forum.