Market authorization holders are required to submit data in single format to do so all the branches/department from pharmacovigilance to supply chain must share common data formats & communication language, they all must comply with dedicated control vocabulary. Major challenge arises while integrating structured substance information, routes of administration, units of presentation, CVs for dose forms and packaging. Also MAHs need to align terminologies across their company scope.
As EMA final IDMP implementation guidelines are still to come and there are speculations of extension of deadline date with a phase wise implementation date line, still July 2016 sun rise date remains to be intact this leaves MAHs with limited time to react and respond to expected enormous changes.
MAHs are required to collaborate internally and externally across all their business areas. MDM i.e. master data management is the most essential element of implementation, as product master data required is present in various different set of systems and functions both internally in the organization and externally with their suppliers/CRO/Partners. It clearly reinstates that business operations and technology departments need to work in harmony and collaborate to formulate strategy to build up capabilities.
The changes required in implementing IDMP standards spreads beyond regulatory affairs; here is simple break up of how the resources and responsibility is co-related in this scenario.
|Medicinal Product information||RIM ,Regulatory||Global/Local Regulatory Affairs Team|
|Pharmaceutical Product information||RIM ,Regulatory||Global/Local Regulatory Affairs Team|
|Marketing Authorization||RIM ,Regulatory||Global/Local Regulatory Affairs Team|
|Packaged Product information||Labeling/ERP||Supply Chain/Commercial Department|
|Clinical particular||Regulatory, Pharmacovigilance, Clinical, Labeling||Regulatory Affairs, Clinical, Pharmacovigilance,|
|Substance Information||Quality Systems, CTD Module 3||Regulatory, Manufacturing ,CMC|
|Establishments||Regulatory,ERP, RIM Systems||Regulatory,Manufacturing, CMC|