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). 

Dear Paolo
in addition to the above mentioned requirements for RPIs the therapeutic area (TA) must be selected.
What is the purpose of this attribute on substance level?
One substance can be developed for different therapeutic areas;
The TA selected during RPI request can not be changed during a specific procedure, only additions are possible.
A SA procedure could be for an indication in a therpaeutic area, different from that displayed on RPI.
Why is the system designed to add a TA already on RPI request?
Why is it not possible to delete this TA if not applicable in a specific procedure?
Looking forward for your reply,
kind regards, Susanne

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.