• RE: IRIS for Industry Companies working in Partnership

    In this answer I assume that by "combination product" you are not referring to a "fixed dose combination product", since this last one would have a single RPI rather than two (RPIs are assigned for development products, substances are mastered in SMS). 
    In IRIS, it is not possible to add an RPI assigned to another Organization (legal entity) to the submission data, even if the other Organization belongs to the same multinational group. This is to ensure the necessary confidentiality of the RPI data that are used and displayed in the submission.
    • In Orphan designations, only one product can be the subject of a procedure.
    • In a Scientific Advice submission, additional RPIs can be chosen but they must belong to the same Organization; additional products for a combination treatment, but belonging to a different Organization, can be mentioned and discussed in the Scientific Document that will be uploaded with the submission.
  • RE: Impact of Organization and Location selected when creating a Submission

    In answer to your question, indeed the location chosen at the start of a submission does limit the RPI or the Regulatory Entitlement (e,g. Orphan designation, previous Letter of Advice): only an RPI or a Regulatory Entitlement which is owned by that location can then be chosen for the submission. However, an user affiliated to an Organization can choose any location for a submission. 
    It is therefore recommended to have all RPIs and all Regulatory entitlements of an Organization assigned to a single location (normally the legal seat/address of the Organization) to simplify the management of submissions. Both transfers can be done in the IRIS portal, and for RPI transfers the procedure is automatic (it does not require EMA approval). 
  • RE: Orphan designation Annual reporting

    Mandatory fields are highlighted with a red asterisk to the right of the field. That said, applicants are encouraged to fill in all the fields in the form. 
  • Presentation on access to IRIS and Research Product Identifiers (RPI)

    For the recording of the training given on 24/09/2020 please click here.

    For the presentation click on attachment below.

  • RE: Q&As on IRIS registration, login and RPI requests

    Please also find here the presentation given at the web training on 24 September 2020
  • Q&A on Scientific Advice submissions in IRIS

    This list of Q&A originates from the Industry consultation group that has been set up to provide feedback on the implementation of IRIS for Scientific Advice. EMA expects to make IRIS available for Scientific Advice applications in October 2020.
    The list now includes additional questions received (previously in a separate thread). 
  • RE: Marketing Status reporting - Marketing Status values

    The video showed the original values for the marketing status, however the current implementation shows the latest RMS list, which contains the values expected.
  • New requirements for RPIs (domain, nature of the active substance)

    In the latest version of the IRIS portal, a modified screen for the request of research product identifier (RPI) has been introduced, with additional automated validation rules that will ensure data quality:

    • a domain has to be specified for each new RPI as either "human use" or "veterinary use" (if both are foreseen, two RPIs should be requested). For "human use" RPIs, it is not possible to include substances that have "veterinary use" as their domain. For "veterinary use" RPIs, it is possible to include substances of any domain ("human use" and/or "veterinary use"). 
    • it is now mandatory to specify the "nature of the active substance" for each substance included in the RPI.
    • it is now mandatory to specify at least one therapeutic area for which the product is being developed. 

    It is now also possible to add information on the mechanism of action (this is not mandatory). 

    Please note that the substances with "veterinary use" domain come from a list that is being updated and cleaned, so it is possible to encounter a few duplicates or language variants of the same substance. Thus, for veterinary RPIs please select the most appropriate substance (the substance may be changed later if necessary and appropriate). 

  • New Q&As on IRIS registration, login and RPI requests

    Please read the IRIS guide to registration before this Q&A document!

    Registration in non-IRIS EMA systems (Account Management, OMS, SMS)

    1. General Manager Role in IAM

    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.

    2. Granting access for all Locations in IAM

    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).

    3. Granting access to IRIS for scientific procedures

    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.

    4. IAM Role needed for submitting Parallel distribution applications in IRIS

    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.

    5. Substances availability in public domain

    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).

    IRIS login

    6. Login Process to IRIS – home page

    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.

    7. Login Process to IRIS – prefilled fields

    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/

    Research Product Identifiers (RPI)

     

    8. Enabling Technologies

    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.

    9. Mechanism of Action - additional information

    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.

    10.Requesting RPI’s in advance

    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.

    11.No SLA for generation of RPI of new Active substance but can be requested in advance

    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.

    12.Need of an RPI in a Qualification procedure

    Question

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

    Answer

    Yes. See also Question 13.

    13.RPIs for non-medicinal products

    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

    14.Availability of RPI list to everyone

    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.

    15.Automatic RPI creation

    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. 

    ADDITIONAL QUESTIONS ON RPI

    • An RPI has been assigned for one active substance to a company ("Company A"). This organisation does now reassign this RPI to another company ("Company B"). What is the consequence of this reassignment for Company A? I assume that both companies can use this RPI in parallel. Is this correct?
      No, only company B can now use the RPI. 
       
    • Or does this mean that this RPI can be thereafter only be used by Company B and no longer by Company A? 
      Indeed,  but company B can reassign back to company A at any time (including during a submission done by company B using the RPI, after it has been chosen and associated to the submission)
       
    • In consequence, that this "reassignment" is essentially a transfer.
      Indeed, that's why the process is called "transfer of RPI". 
       
    • Would is be possible that for an "old" and well-known active substance two companies assign RPI individually, i.e. that different RPI exist thereafter for the same active?
      Yes, this is in fact the rule for off-patent products: separate RPIs for generic products. An RPI tracks a development programme, essentially, rather than a specific substance or fixed-dose combination. As a consequence, if the same (off-patent) substance is developed independently, this is reflected in different RPIs. At the same time, the same development programme for a (normally patented) product would maintain the same RPI, regardless of transfers of the product to a different developer, mergers, use of consultants, etc.
  • Deadlines for resubmission implemented in IRIS

    Applicants should be aware that deadlines for resubmission have been implemented in IRIS. Whenever a submission is reopened, a date is set by the case manager for automatic re-lock of the submission. After that date, it will not be possible to edit the submission. You will be informed of the deadline via email. 
    Please remember to complete any resubmission by re-closing it using the "Declare and submit" button. 
     

    Resubmission modalities

    • Before validation: for cases (procedures) before validation, it is possible to edit the data in the portal and to upload new or revised documents (these last will overwrite any existing document with the same name).
      It is not possible to delete previously submitted documents. 
    • After validation: for cases after the start date, e.g. at the time of the list of questions, it will be possible to upload new or revised documents (these last will overwrite any existing document with the same name).
      It is not possible to delete previously submitted documents, and it is not possible to edit the data in the portal.