This blog is part 1 of a series of reflections post DIA’s 2019 Regulatory Submissions, Information and Document Management Forum.
IDMP (Identification of Medicinal Products) is a suite of standards developed to provide an internationally-accepted framework to consistently identify and describe medicinal products.
I know, I know! We’ve been hearing about this for what seems like a decade now, and the due dates seem like they have been pushed back to infinity.
That’s why, at this point, we are no longer looking at this as an IDMP compliance thing, but rather a critical business as usual function.
IDMP was once again a hot topic at DIA RSIDM this year, and for good reason. Meeting these regulations will be a very large, multi-year undertaking for any pharma company, let alone the companies with hundreds of products to manage.
The FDA and Health Canada are tracking this closely, as they will be looking for similar requirements in the near future, potentially before IDMP goes into full compliance mode.
As a health authority representative said in one of the main sessions (and I am very much paraphrasing):
In regard to IDMP, what are you doing to create, manage and track this data today? IDMP should be an add-on to what you are already doing. If you’re not capable of doing these things right now, there is something fundamentally wrong with your business.
Unfortunately, I’m here to tell you that the vast majority of companies are not capable of providing and using this data today. Many of you are five plus years away from being able to comply with these regulations.
So, my main emphasis on the IDMP regulations is that even if the regulations keep getting pushed back, you are unlikely to meet the goals in time unless you start right now.
Per Kelly Hnat (of K2 Consulting) at the DIA RSIDM forum, here’s the current expected timeline:
Mid 2020: Iteration 1 Implementation Guidelines Released
Mid 2021: Initial Submissions Accepted
Mid 2022: Enforcement by EMA
To reiterate, though, simply meeting the regulations should not even be your goal.
Having access to and being able to act on this data is critical to running your business.
There really isn’t a downside to starting this initiative right now. Today. Because any progress you make towards meeting the IDMP regulations will push your business to the next level with a proactive approach to data management.
Stay tuned for more on IDMP. In upcoming posts, we will discuss some of the high-level tasks that should be on your to-do lists and capabilities that you will need to harness in order to manage data in a way that fuels your business and, as a secondary benefit, complies with the IDMP regulations.