One of the first steps executed by the EMA to prepare for the implementation of ISO IDMP will be the migration into the new PMS database.
The EMA intends to migrate the data held in the eXtended Eudravigilance Medicinal Product Dictionary (xEVMPD) and submitted by marketing authorisation holders (MAHs) under the Art.57 (2) legal obligations since 2012, into the ISO IDMP-compliant data format and terminologies.
The transformed data will be loaded into the PMS hub. This approach is expected to:
- Allow building of the new ISO IDMP compatible repository [i.e. Product Management Services (PMS)] from the data submitted since 2012 under the Art.57 legal obligation.
- Provide external stakeholders with services (i.e. API) for the access and retrieval of their own data previously submitted in Art.57 data format [i.e. via the eXtended Surveillance Medicinal Product Report message (xEVPRM)] transformed and remapped into the new data format and terminologies for further validation and enrichments.
- Facilitate business continuity ensuring that PMS contains data comparable with what is available in the Article 57 database and currently supports the EMA business and regulatory processes until integration with PMS will be implemented.
- Facilitate transparency and comprehension of the data transformed into the new format by stakeholders and owner of the data.
As the preparation for this implementation is progressing fast, EMA has planned to start the activities for the migration of the xEVMPD database into the new PMS database in October 2020. To avoid and reduce unnecessary data input and output into the PMS database, it is extremely important to check and align the data before EMA migrates the xEVMPD data into PMS.
For this reason, Asphalion highly advises companiesthat didn’t check EMA’s 3rd Acknowledgements to perform a quality check of the xEVMPD data versus the RIMS data or local database available.
Asphalion can provide you with complete QC with a data analysis report, support you with data submission/ updates and identifying possible changes in the SmPC that should be considered for future variations as a result of EMA 3rdACK process.