Pharmaceutical companies are required to maintain a wealth of data, particularly as it pertains to substance information for drugs and drug products. Until very recently, this data has been stored in a sub-optimal manner, making it difficult to search and track adverse events.
By end of 2018, all drugmakers who market their products in Europe will need to report their Chemistry, Manufacturing and Controls (CMC) data in a structured format, compliant with Identification of Medicinal Products (IDMP) standards. I spoke with Jacob Ekstrøm, Advanced Business Consultant, Life Sciences Industry, NNIT, to learn about the steps pharmaceutical companies must take to ensure they’re ready for these changing regulations.
For more on IDMP requirements for substance information and ensuring compliance with impending EMA regulations, watch NNIT’s on-demand webinar.
Can you give me some background as to why the EMA will start requiring data to be formatted in compliance with ISO 11238, beginning in 2018?
Well it all originates from the Extended EudraVigilance Medicinal Product (xEVMPD) initiative back in 2012, when there was an initiative to report a subset of structured data for the European Medicines Agency (EMA), and then the International Organization for Standardization (ISO).
These standards were also formed for the IDMP in that same year, so we knew at that point in time that there would be extended requirements for reporting data. Back in the xEVMPD reporting, we only had to touch very briefly on substance information. This was mainly concerning the registration of products and the composition of the products for administrative purposes.
Now they require much more information about the substances in individual products and also on the packaging. And what they’re actually aiming for, as I see it, is that they eventually want all information for drug registration to be structured.
How is this data currently formatted, and how does that differ from the new format?
Currently, and historically, it was just submitted to the authorities in a paper format. Of course, this had to be structured in a certain way but is was still just a document. Now they want actual pieces of structured data reported, so that they can search across a lot of different substances.
As of right now that’s virtually impossible for the authorities to do because all of the information is in documents. While that data could be in the form of electronic documents, searching across so many different substances and products is nearly impossible. That searchability is what they’re trying to achieve by getting all of this information in a database going forward.
I see, so it’ll be more easily searchable then?
It will be more searchable, and it will be more treatable because what it all comes down to is patient safety. If the authorities get a single report or multiple reports on one particular substance, they want to be able to trace this substance back to where it originated. They want to know where this particular substance was produced, who manufactures it, what its grade is, where it is used, and in which products globally.
Will organizations be required to establish a dedicated substance repository in order to be compliant with new regulations?
They will be required to report to the EMA repository, but how they will want to do this reporting is all up to the organizations. They do need to do it prior to registrations of products, and to be more efficient we strongly recommend that they actually build their own internal repository to report this data.
This type of substance information represents a huge amount of data, and if companies choose to handle this requirement by hand through an EMA-developed web portal, it will be very expensive and time-consuming. This is why we strongly recommend that companies build their own internal repository so that they actually have control of their own data.
So this would allow companies to have their own traceability on their end as well?
Exactly, and then you use a gateway to transfer the required data to the EMA. In the future, you would also be able to transfer the same sort of data to the FDA, or other regulatory agencies across the world.How do these regulations differ from the data formatting required by the FDA?
We don’t know the exact requirements from the FDA, or any other regulatory agencies besides the EMA yet, but we expect it to be very similar to what the EMA is requiring. You will likely be required to record almost the same subset and amount of data structured in a similar way, but there could be regional differences. Maybe one region will require additional information, but we expect the majority of the data to be consistent across the other regions.
Can you tell me how NNIT fits into all of this? How can you help companies actually build these repositories?
Well, we help them do the analysis of their internal IT systems to actually dig out where the data is stored within their own particular company. Our experience tells us that the majority of this information is not found in IT systems. Substance information is usually found in documents, so we advise pharmaceutical companies on how they can get this information structured.
This service helps pharmaceutical companies prepare for IDMP reporting. We can help them implement a system for reporting this data, with the structured substance information (SSI) data being just one part of this entire set of data that needs to be reported to the EMA with the IDMP requirements.
Still have questions about the EMA requirements? Watch NNIT’s webinar on preparing your CMC data for IDMP e-submission.