Markus Pfahlert, Product Manager of LORENZ drugTrack, participated in the ISO IDMP Task Force Meeting in September and compiled this summary of the outcome.
The European Commission agrees to the Phased Approach
The transition phase will consist of two parts; the Pre-Submission Phase and the Submission Phase itself. Directly following that, the Maintenance Phase will begin.
The Pre-Submission Phase is planned to begin in July 2016 and to continue through the beginning of 2017, with three primary goals:
- Migration of EVMPD data to IDMP on the EMA site
- Pilot with demo products, to be developed by the S&P Group
- Compliance with EC Legislation (IDMP begins July 2016)
This will be followed by a Submission Phase (Q1 2017 – Q3 2017) during which the option to submit in the IDMP format will be offered.
Starting in Q4 2017 the Maintenance Phase (IDMP only) will commence.
Since the current proposed ISO IDMP Guideline has attracted some 800 comments, and will need to be completely re-worked in some parts, there is the danger that a second approval may become necessary. This could lead to a 6-month delay in its implementation, which could also lead to a further delay of the related EU IDMP Implementation Guideline. It’s currently not possible to predict whether this delay will actually happen or not.
SCOPE OF IDMP PHASE 1
Compared to the EVMPD with 59 elements, the S&P Group for Iteration 1 of IDMP will focus on approx. 92 elements.
These elements have not entirely been confirmed yet, and the discussion in the plenary showed that some may have been overlooked so far (for example once again „use in children“), and others are still not sufficiently clear. But the overall list will look roughly as follows:
- XEVMPD direct equivalent elements
- Additional name parts
- Regulated document: Doc types, Doc ID, Regulated document, Doc effective date, Country/Language
- Legal status of supply
- Date of first authorisation
- Marketing status (clarification is needed on whether this is the MPID or individual PCIDs)
- Indication: in addition to the MedDRA coding – Indication text, Comorbidity, Intended effect
- Pharmaceutical Product: Unit of presentation
- Pharmaceutical Product: Device: Device type – clarification that this is Advanced Therapy products only, Device trade name
- Ingredient role (clarification is needed on how detailed this must be)
- Specified substance (EMA wants SSG 1, 2 and 3)
- Strength presentation/ strength concentration
- Reference substance/ reference strength
- PhPID set (to be assigned)
- PCID (to be assigned)
- Pack description (required in IDMP)
- Package item – Container type (clarification needed as to what levels – outer, intermediate, immediate?), Quantity, Material/Alternate material
- Pack Component: Component type, Material/Alternate material
- Manufactured item, Unit of presentation, Quantity
- Package Medicinal Product: Device: Device type, Trade name, Device listing number, Model number