By Rune Bergendorff, Managing Consultant NNIT Life Sciences“After the rain, comes the sun” goes the saying, and it couldn’t fit the situation of IDMP better. While EMA postponed the submission of product and substance data in the European Union in June (read more here), the FDA has been working on finalizing their draft standardization on the exact same topic.
On July 11, “Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies; Request for Comments” was issued on
Regulations.gov. In essence, this is the FDA’s request for comments on the structuring of the content of pharmaceutical quality and chemistry, manufacturing, and control (CMC) part of the CTD with the purpose of assisting the review of Module 3.
It may very well be. The FDA has taken a different approach than the EMA. They have isolated Module 3 and defined data elements (fields) as they fit the document. The next step has been to match those fields with IDMP where possible.
This means that the structured content is not 1:1 with the IDMP fields but goes beyond, which shouldn’t be an issue as HL7 and the common product model carries a lot more data fields than those defined in the IDMP standards. It will, therefore, be possible to extend the current SPL submission to include these additional fields while maintaining compliance with HL7. A smart move!
The way that the FDA has set it up seems to be much more integrated with the regulatory processes and seems to be a natural extension of what we do today.
It is still early days, and as it is a draft for commenting everyone must be careful in drawing premature conclusions. The document outlines 215 fields, but these are not unique as a set of fields is reiterated for each of its use cases. E.g. manufacturing details are mentioned both for the API and excipient manufacturer.
The main areas overlapping with IDMP refer to:
Product name, dosage form
Manufacturing information for API, excipients, product
Substance (CAS, INN, USAN, structure etc.)
However, even between the above topics, the specification in many areas goes beyond that of IDMP and, furthermore, it carries a lot of detail around the test and analysis that is not at all described in IDMP.
Until September 11, comments are accepted on the draft standardization. Hereafter, comments need to be incorporated before anything can be issued publically and finally. A best guess could be that we will see something during Q1/Q2 2018 after which we will have 24 months for the implementation.
In the meantime, the logical steps are to read and digest what has been published and figure out the road forward, determining a split between IDMP and non-IDMP by laying out a high-level plan for how and when to move forward.
NNIT has buckled up and is currently reading, digesting, and developing a viable path forward in due time. Hear more about this topic in our coming
webinar on September 6.