Paolo Tomasi EMA

The therapeutic area is an attribute of the RPI, not the substance. An RPI can contain more than one substance, and two different RPIs containing the same substance may be aimed at different therapeutic area.

The RPI is used to track the product development across separate EMA procedures in the lifecycle, at present ITF, orphan designation and scientific advice, that have the same development product in common. Therefore, the RPI tracks all therapeutic areas in which the product has been, is being, or is likely to be developed. It does not apply to just a single procedure. For this reason, it is not possible to remove a therapeutic area once a request for a new RPI has been submitted, or in the course of a new submission for that RPI. Similar considerations apply for the enabling technologies associated to an RPI.

However, it is possible to add one or more enabling technologies or therapeutic areas, during the creation of a new Scientific Advice submission, if the product development now addresses them, and they need to be discussed in the new procedure. Addition is voluntary. The same feature will also be added, in future, to Orphan submissions. 

The following are answers to questions received from Industry at the Stakeholder Meeting organised by the Evidence Generation Department i November 2020. During the meeting, there was reciprocal feedback on the experience with the go-live of IRIS for Scientific Advice. 

IRIS for scientific advice - EMA R&D Platform Nov 2020
Industry questions and EMA answers

First experience/ feedback
 

1. Scientific advice: What did EMA see post go live? Any improvements/ adjustments planned?
   Continuous improvement is at the core of IRIS development and deployment cycle. New IRIS versions are released frequently, and any improvements or changes in the Industry portal will be communicated via the IRIS Forums. Please submit any suggestion for further improvement either as a EMA ServiceDesk ticket, or in the IRIS Stakeholder Forums.  
2. Marketing Status: go live is Q1/2021.  Is scope for sunset clause monitoring, or also for market withdrawals?
   Details on the new date will be provided as soon as they are available. Specific features that are not present at go-live may be introduced in one of the new releases of the system.
3. Marketing status: this is in IDMP iteration 1, why IRIS?  Is this duplication?
   It is indeed correct that the Marketing Status information are part of the ISO IDMP standard. The regulatory platform (IRIS) will still offer the user interface where to submit the information even when IDMP will go live. So, it is not a duplicate of the initiatives, it anticipates the functionality.
4. Marketing status: Is PSMF data entry still required?
   As it stands PSMF is still required to be filled in and no change is foreseen in the short term.
5. General: NCA assessors have just been granted access to the IRIS system (5 November).  What IRIS processes will they engage in?
   NCA Assessors can visualize and contribute to any procedure managed by IRIS (currently: Orphan designations and allied procedures, ITF, Scientific Advice human and veterinary)
6. Process improvement: could a combined group of users involved in testing form a core user community including designated company super users?
   For the time being EMA plans to continue with ad-hoc industry stakeholder groups to provide feedback and suggestions for separate procedures groups to be onboarded in IRIS. This may change in the future.
7. Process improvement: could we work together to mutually agree a reasonable notice period for new IRIS modules?
   The need for Industry to receive timely information on the expect go-live date of new IRIS modules is acknowledged. A minimum 3 months advance notice seems to be the most practical and appropriate. We intend to do this via the IRIS Forums (potentially a new Forum could be created for this ‘strategic’ information).
8. Process improvement: Would it be possible to develop a dashboard of past & ongoing company activity, regardless of procedure?
   This requirement is addressed by the new role of IRIS Industry General Manager, which is being currently developed.  Persons with this role will be able to see all submissions made on behalf of the organization(s) to which (s)he is affiliated.
9. Process improvement: Multi-site/ development partner access can be challenging, would EMA consider working together to develop a module for management of IRIS access, including different roles and deputies?  
   The current access management system allows individual users to be affiliated to different organizations, with specific roles for each, and should support most of the requirements. EMA is always interested in receiving proposals for improvement of the system.
10. Process improvement: could the IRIS Forum evolve into a more structured support service, to more broadly share helpful discussions with the wider community? With key announcements on EMA and IRIS home pages?
    We see the Forums as an arena where applicants can help each other, and where EMA can provide announces about new development and new features of the existing modules. We plan to publish an update at every IRIS release, geared specifically at applicants. Requests for technical support on specific submissions, or access problems for a specific user should continue to be submitted as ServiceDesk tickets. 

Outlook for business use of IRIS
 

11. We are keen to have visibility of the IRIS roadmap, when will it be ready to share with us?
    The draft roadmap is being finalized internally at EMA. More information on the highlights will be shared with the EU Regulatory Network at a later stage, and subsequently with Industry. However legislative changes and resource availability may have a significant impact even on the high-level objectives.
12. Will the IRIS roadmap connect to the EU Network and Telematics Strategy?  
    IRIS is not an EU Network and Telematics Strategy project. There is however a link, as IRIS is a component project within a broader framework, which connects to other projects (such as SPOR) in the realm of the EU Network and telematics strategy. 
13. Is the IRIS roadmap part of a wider EMA data strategy, with an aim of ensuring business process outputs are just entered once and reused as many times as needed?
    Yes, this is indeed one of the main drivers of IRIS: increased efficiency, increased security, improved knowledge management.
14. Will DADI (Digital Application Dataset Integration) be built as an IRIS extension?
    DADI is about building the necessary standards and tools to exchange information across the stakeholders involved in the regulatory process (EMA, NCAs, Industry). IRIS is the platform designed to manage submissions and regulatory process management.  
15. Could we have a list of all the source IRIS uses, in addition to e.g., SPOR Organisations, Referentials and SMS list? How is maintenance synchronisation performed?
    At the moment, IRIS integrates with: SPOR (SMS, OMS, RMS), SAP-FIN (to generate invoices), SIAMED2 (for centralised procedures and regulatory entitlements), PedRA (for PIP/waiver decisions). The frequency of synchronisation is fortnightly for data coming from SIAMED2 (CAPs, regulatory procedures available in SIAMED2 and Regulatory entitlements) and daily for SPOR (SMS, OMS, RMS).

 

For communication regarding a specific submission, please contact directly the relevant office, by replying to an email sent via the IRIS system for the specific submission. Please do not change the subject of the email when doing so. 
 

The last column of the "Ongoing submissions" table, "Case status" shows the progress of the Case (procedure) associated with the applicant's submission. Please note that the "Case status" names are being consolidated for the various procedures, and may not correspond to previous definitions for a specific procedure. Email communication is only made when an active reply or intervention from an applicant is required. 

The list of centralised procedures in the dropbox is filtered by company, not by RPI. Please note that the update of this list is still manual, and there may be several days of delay (up to 3 weeks) before the IRIS list is updated. We plan to do the import every two weeks very soon. If there is an urgent need to make a procedure visible, please contact EMA service desk. 

Industry Portal Changes

1. New features added: auto-assignment of submission manager and possibility to add more managers during the submission process. The system will now auto-assign the current user as Manager and Portal Contact of the submission, while creating any submission request. The user does not need anymore to select him/herself as manager. In addition, the user will be able to add other managers or contributors for the submission at this early stage. 
 
2. In all relevant submission process types where a user selects an RPI for transfer or submitting request for an RPI, the guidance text has been updated to clarify that RPI transfers to a different sponsor/applicant can now be done directly in IRIS via an automated process. There is no need to raise a Service Desk ticket anymore.
 
3. A description text for the parallel distribution process has been added to the IRIS portal

4. UK has been replaced with UK(NI) in the Parallel Distribution selection screens and also in a subset of PD regulatory entitlements. 
 

The function is at present intended to support Orphan Designations only. The process will be expanded to allow self-management by Industry of the contact points for public enquiries regarding orphan designations, currently managed via the standard EMA website. While the process is being improved, sponsors of Orphan-designated medicinal products are welcome to update the data in the Industry portal. 

Name review requests are not processed in IRIS at present. Currently we are not planning to move this feature to IRIS in 2021. 

Your request for RPI has been approved yesterday. When a withdrawal is requested, the system automatically sends an acknowledgment, asking the applicant to inform us if this has been a mistake. In such cases, the procedure will not be closed but will be progressed normally in the system. 
 

Dear Ms Bettendorf, I have checked the ServiceDesk ticket and you were contacted 3 days ago with additional information, which I have now supplemented.