Last week,
Remco Munnik, our Regulatory Information Director, attended the ISO IDMP S(ubstance)&P(roduct)
meeting at EMA.
Based on
the experience of xEVMPD, it is recommended to start preparing your company now
in order to have the required data available once required.
Please find
below a summary of last week’s ISO IDMP meeting:
ISO standards
It is expected that the latest standard will be ready around Q1 2017 (could be
further delayed in case of need for additional ballot).
The EU ISO IDMP implementation guides can only be published, once the ISO
standards are final.
The EU guideline will be developed in parallel in order to be able to publish
the guidance as soon as the ISO standard is final.
Key topics in EU guideline:
Data requirements iteration 1 scope has to be determined as soon as
possible
- EUDNB (NCAs and EMA) will review the business case and data requirements
for Iteration 1 - Detailed guidance on the assignment of MPID, PhPID and PCID to be
provided - Implementation of SPL model in EU
- Migration options of xEVMPD into ISO IDMP
SPL
FDA provided a demo of the SPL implementation in US and implementation of ISO
IDMP in US.
FDA will collect all data for ISO IDMP from the SPL..
General agreement in workgroup that the FDA solution should be further analysed
for EU needs.
Referentials & Organisations is
key
EMAs focus in 2016 is on getting the information of the referentials and registration
of organisations
This is key for the success of the project.
Agreement was reached for alignment with US for data sharing.Databases
for Organisations and Substances should be global database.
