On 22nd February 2021, the long-anticipated moment happened: the European Medicines Agency (EMA) has published the EU IDMP Implementation Guide version 2.
The EU IDMP Implementation is finally here!
This event is very important for the life sciences industry as it starts the clock for the implementation of the product and substance data submission iteration 1 timelines in the EU.
What’s in
IDMP Implementation Guide (IG) version 1 was published back in February 2020; however, it did not include all the information needed to actually implement the product data submission according to the IDMP granularity. Therefore, the EMA has bound the implementation timelines to the release of IG version 2.
Version 2 of the Implementation Guide which has been published today, has the following chapters significantly revised:
- Introduction
- Chapter 1: Registration requirements
- Chapter 2: Data elements for the electronic submission of information on medicinal products for human use
- Chapter 3: Process for the electronic submission of medicinal products information
- Chapter 8: Practical examples
Chapter 1 outlines the SPOR prerequisites and preparation steps prior to the actual submission. Chapter 2 now provides a detailed guidance on which product information fields need to be submitted and which are the applicable business rules while Chapter 3 outlines the process for both, the initial and maintenance product information submissions for different regulatory procedure types. On top of that, Chapter 8 provides numerous examples of products where IDMP implementation is particularly complex.
The following chapters were not changed since IG version 1 as they were already considered to be (more or less) complete:
- Chapter 6: Technical specifications on structure and format
- Chapter 7: Migration guide
What’s out
Although the EMA has put a lot of efforts in amending those chapters, only those review comments with the highest impact were addressed so far. The remaining comments will be addressed in versions 2.1 and 2.2 which are to be published in Q2 and Q3 2021, respectively.
What is particularly missing in IG version 2 are the comprehensive RMS value lists and more clarity on identifier assignments) as well as practical FHIR examples. Although the target operating model (TOM) is finally defined (e.g., when a change requires an eCTD submission, the FHIR messages will have to be submitted as part of the working documents, only containing the relevant data elements), there are for example still no clarifications on how parallel variations will be managed.
There are also chapters which are yet to be finalized as part of IG version 3 and will bring further details on the following implementation aspects:
- Chapter 4: Data Quality assurance
- Chapter 5: Data access/export
- Chapter 9: Process for submitting legacy data on medicinal products authorized for human use.
IG version 3 is expected to be published in Q1 2022.
Despite several gaps remaining, IG version 2 still brings the industry and vendors a solid base to move forward with actual implementation efforts.
What’s next
The release of IG version 2 starts (at least) 12-month transition period before PMS iteration 1 goes live. It is important to understand that TOM implementation in step 1 only covers Centralized Procedure (CP) type. It is obvious, that the EMA and National Competent Authorities (NCAs) need more time to address all the nuances for the remaining procedure types (MRP, DCP, NP) to be incorporated in the TOM. It is anticipated that those will be covered in IG version 3. Until then, PMS data submissions for MRP, DCP and NP procedure types can be done only after the regulatory procedure is complete.
One important transition aspect to mention is also the discontinuation of XEVMPD. This is supposed to follow the enforcement of each respective implementation step. In practice this means that XEVMPD stays in production at least until February 2022 for CP.
The deadline for mandatory use of FHIR format for PMS submission is yet to be announced until IG version 3 is published.
At AMPLEXOR we were closely involved with the review process of both IG versions, so we are very familiar with all the opportunities and challenges of bringing IDMP to life within our solutions. We are excited to move forward with our support for the industry to stay on top of the EU IDMP implementation journey and bring broader business benefits of holistic data-driven regulatory solutions to life.
Agnes Cwienczek
Head of Product Management & Consulting
About the author
Agnes has been in the position of ALSS Head of Product Management and
Consulting since May 2017. Her main responsibilities are the contribution to
the development and enhancement of the Amplexor Life Sciences Suite,
supervision of the Life Sciences Consultants as well as the provision of
business process and data management expertise to Amplexor clients in
Regulatory Information Management, Document Management, and
Submission Management.