SPOR, IDMP & ROG updates from the meeting with EMA

SPOR, IDMP & ROG updates from the meeting with EMA

EMA
presented an updated plan for the ISO IDMP implementation.

The summary
of the updated plan implies:

1.The EU Implementation Guides (EU IGs) will not be
published in 2018

2.Industry will not be requested to start
submitting the product data IDMP format in 2019

Further
timelines will be developed, but basically this means a further delay of ISO
IDMP implementation, which has impact on your internal projects and timelines.

The
background for the delay is the relocation of EMA (as a result of Brexit), but
also the experience gained for the release of the Organisation and Referential
data and planning for the S&P release.

In
addition, EMA shared that on 19th June the O&R reference data
has been released.

NCAs will
have O&R to perform mapping of the O&R data to their internal systems.

Industry
will have access from October onwards to O&R data.

The
Regulatory Optimization Group (ROG) continued discussion for the optimisation
of the current regulatory processes and building business cases.

For the
manufacturer information in the eAF/CESSP, it was discussed and recommended to
already implement the mandatory use of O data.

In
addition, the processes of Variations were discussed for which different
optimization possibilities were discussed and identified.

The ROG
will proceed with building the business cases for discussion at HMA in October.

If you have
any question, please contact us at idmp@asphalion.com for a further discussion about the impact and next steps of the ISO IDMP
project.

Barcelona official candidate for European Medicines Agency
Asphanews June 2017

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