There will be updated regulations by the end of the year for the Global Ingredient Archival System (GInAS). Compliant with ISO 11238, this update is expected to be at the Specified Substance level. The GInAS project will eventually supplant the current FDA Substance Registration System. G-SRS will provide a common identifier for all substances, a “global information system for pharmaceutical ingredients,” including active substances under clinical investigation.
So the time is now to prepare. Starting an internal mapping exercise of the data element for each MP on the market will serve two goals. First, it will exhibit data gaps within your organization. Second, it will serve as a crosscheck should GInAS be used in Europe.
Levels of Complexity
When looking at Substance Names, we can submit as many as available. However, it might be wise to set a strict, internal mandatory minimum for maintenance purposes, even for Laboratory/Company Codes. In addition, establish business rules about the most relevant or significant qualifiers to identify a substance. Substance Names/Laboratory Codes, which reference source(s) and version(s), and how many and which ‘Properties’ should be submitted for a given substance, are some of the questions you will be asking yourself during this process. Remember, some data elements will be easier to extract than others. Since IDMP sets its own data definitions, qualified people within your organisation must familiarize themselves with the latest ISO standards, draft technical specifications, and standardized definitions.
IDMP Substance Data
Depending on the complexity of your product/molecule portfolio, generally the effort to collect IDMP Substance Data can be divided into three major categories:
- third parties
The first category, in-licensed, is the simplest of the three, but it still poses some complexities. Here are some questions we recommend asking yourself and your team:
-Do you think the quantity of available data will be the same for any ‘active substances’ with a pharmacopeial monograph and for those without one?
-If you decide to refer to a monograph, would that information be sufficient?
-What should be the most appropriate pharmacopeia version to cite: The edition at the time of IDMP data submission or the one used when submitting the marketing authorisation application for a medicinal product?
The second category, third parties, might require more effort. It will involve obtaining very specific, complex data from a third party. Here’s one scenario to consider: Would your current contractual agreements ensure compensation for identifying and providing up to 400-500 data elements per substance with variations across up to eight different substance types? The third category, out-licensed portfolio, will likely require more effort than category 1, though probably less than the second category.
Excipients and Pandora’s Box
Considering recent Task Force conversations, it appears the European Medicines Agency expects to receive the same level of detailed data for excipients as they do for active ingredients. This is in spite of industry pushback — knowing that very little of this data will be available within organizations, particularly with suppliers, flavours, colourants.
That said, here are some questions and concerns to consider:
-Does your organisation currently have the same amount of data expected by IDMP for a flavour as any of your actives?
-While a small subset of data might be available from your product dossier, will it be fully compliant with ISO 11238?
-Does your substance data reside in your systems or in your documents?
-Would it be the same group that owns it for different types of substances (chemicals, proteins, nucleic acids) and for different types of ingredients (active substances, excipients)?
Conducting an IDMP Substance Gap Analysis will help you answer these questions and many others that you will likely face as we navigate these new waters. Remember, one of our aims is to create awareness and build momentum in order to deliver IDMP substance information rapidly across your organization. Following the gap analysis, you should also examine your communication and data collection and exchange processes, especially where it involves third parties:
-Are they aware of ISO IDMP definitions and requirements for substances?
-Have you reached out to your ingredient suppliers about IDMP? Are they ready to provide you with the level of detail you need? At what cost?
These questions must be answered and the answers must be scrutinized. Gaps or shortfalls must be identified and rectified as soon as possible to checkoff the major and minor points addressed in this piece so that your organisation is ready for IDMP substance models, regulations, guidelines, and submittals as well as any iterations or changes in approach.