Question

Is there a Role of “IRIS Industry Coordinator” who can see all submissions belonging to an organisation?

Answer

Yes. The role exists and can be requested in IAM. You should request this role only if you want to see and edit ALL submissions for the organization to which you are requesting affiliation, created by any other user in the organization. With this affiliation role, you are able to access those submissions, add other managers and change the portal contact (person receiving emails for the submission). This affiliation role by itself does not allow to create new submission (the Industry Manager affiliation role is necessary for that). Please note that this role is optional and should be granted by the IRIS Industry User Admin only if they are aware of the implications. The role may not be suitable for a consultant, who is acting on behalf of the organization.

Question

Can a user with the “IRIS Industry admin” role grant a role for all locations/ORG-IDs at once?

Answer

Yes, this is how IAM works. An Admin grants affiliation to an organization, which includes all locations that belong to the same parent organization (one legal entity = one organization).

Question

Will the “IRIS Industry User Admin” be responsible for granting affiliation to users, irrespective of the procedures to be managed in IRIS?

Answer

Applications for all "scientific" procedure in IRIS can be created with the same IAM affiliation role. This includes e.g. Orphan drug submissions, Scientific Advice, ITF, PRIME, Inspections, Marketing Status, and future procedures that will be included in IRIS (including Paediatrics, Variations and other Centralised procedures, etc.). However, Parallel Distribution procedures require a different IAM affiliation (see question 4). Of course, the same person can be affiliated to the same organization for both "scientific" procedures and Parallel Distribution procedures, if desired.

Question

Which affiliation role is needed to submit parallel distribution applications?

Answer

You need to request the “IRIS Parallel Distribution manager” in IAM, with affiliation to your Organization. A separate person with an existing “IRIS Parallel Distribution admin” role in your Organization will have to authorize your affiliation. See also question 5.

Question

Is the list of substances publicly available?

Answer

Yes, IRIS includes the all SMS substances that are “approved” and “current”. Only these substances are suitable for inclusion in an RPI. The full, searchable list is available here: https://iris.ema.europa.eu/substances/. Use an asterisk as first character for your text, to improve sensitivity. If you cannot find a substance in IRIS, but you believe it to be present in SMS/EUTCT, it probably means that the substance is marked as a “development” substance in SMS, and thus not imported in IRIS; in such cases, please request registration of the substance in SMS as if it were new.  Please note that substances and RPI are different lists (see question 6).

Question

After affiliation has been granted in IAM, login to IRIS can be confusing: an initial Microsoft login field is then followed by a regular looking EMA login page. Having to type in the “@id.ema.europa.eu” is also a hurdle. Can this be simplified?

Answer

IRIS is based on Microsoft Dynamics and Azure technology, where the two systems interact in the cloud. As such, EMA has limited control over the general interface. The Microsoft login page has been removed, however.

Question

Is there any way to simplify login, by having credentials saved/prefilled?

Answer

Pre-filling the username is not possible directly, but one way to mitigate this is to allow the browser to remember the credentials, so that next time the page is open it is pre-filled with the username. This is equivalent to pre-filling.

This is a general function of all modern browsers (EMA recommends Chromium-based browsers, such as Edge, Chrome or Vivaldi).

The link below can help you to address this issue:

https://pureinfotech.com/add-new-user-profiles-google-chrome/

Question

What is the meaning of “Enabling Technology”? Why is this information needed?

Answer

Possible innovative aspects on the development of the product (RPI) are tracked using this list, to ensure involvement of specific expertise as required and to allow forecasting and planning.

Question

Why is a “mechanism of action” (MoA) field included in some electronic forms? This information may not be fully known, especially for very early advice. Will this information be made publicly available?

Answer

The field is not mandatory, therefore if the applicant does not have information to provide, in addition to that available from public sources (which will be displayed in read-only), it is possible to leave the field empty. It is in the interest of the applicant to provide as much information as available, to allow the SAWP/CHMP to provide targeted advice or a correct Opinion. Any additional information on the mechanism of action, provided by the applicant, will not be made public by EMA.

Question

We may have several scientific advice procedures planned for Q3/Q4 this year. Is it possible to already start preparations for requesting RPIs? i.e. before the IRIS system goes live for Scientific Advice submissions.

Answer

Yes, it is possible.

Question

Can an RPI for a new product be done within 2 working days, to prevent delaying  submissions?

Answer

There is no SLA for RPIs. In almost all cases so far, RPIs has been granted within 2 working days. Of course, this also depends on the reactivity of the applicants to answer any questions in those rare cases where communication is required. The best way to avoid delaying a submission remains to register any new substance and request an RPI well in advance of the submission of an application to EMA; this can be done months in advance.

Question

Is an RPI needed for a Qualification procedure? (Advice or Opinion)

Answer

Yes. See also Question 13.

Question

For a scientific advice or qualification advice/opinion procedure of a novel methodology (such as qualification of a novel endpoint supported by a digital tool) which is not linked to any substance, how can we obtain a new RPI? Should we proceed through the IRIS portal,  or through the former submission process as described in the "Qualification of novel methodologies for drug development: guidance to applicants" (e.g. via qualification@ema.europa.eu)?

Answer

Qualification submissions will be handled through IRIS, but they still require an RPI. For non-medicinal products, however there is a different procedure, as the RPI cannot be requested via IRIS. Please contact the Scientific Advice office directly, at ScientificAdvice@ema.europa.eu. 

Question

Once an RPI is requested for a new active substance(s), will it appear within the substance list accessible to everyone via IRIS homepage?

Answer

RPIs and substances belong to two separate lists. While RPIs are linked to a specific organization or individual, substances are not. Furthermore, an RPI for a product may include more than one active substance and is intended to track a development entity rather than just the concatenation of the active substances. At present, RPIs are not publicly available in IRIS and each organization only sees the RPIs assigned to it; this may change in the future.

Question

When asking for an RPI in IRIS, why is it not possible to simply fill in the active substance(s) details in IRIS during the intended application, and then an RPI is automatically created in the system?

Answer

This is not possible because the two are separate processes, with separate management at EMA. Substances are mastered in SPOR, they are not assigned to an applicant, and are public (except for their restricted synonyms).

As detailed in Question 6, RPIs are permanent and do not change across the lifecycle of a (candidate) medicinal product. Therefore, a new RPI should not be requested if one already exists.