Global harmonisation versus national regulatory considerations

Background, from UMC point of view Implementation of E2B(R3) automatically leads to questions regarding IDMP Implementation of IDMP may result in local solutions: Risk of local assignment for substance IDs, local controlled vocabularies Risk of local variations of PhPID algorithms to fit local use case  UMC offers to be maintenance organisation for marketed drugs on a global level to avoid local variations of PhPIDs

E2B(R3)

Pre-market vs post-market In the pre-market setting sponsors apply to local regulatory agency Each NCA needs to approve drugs in their own country Trade secret rules may apply May check global database if drug approved in other countries In the post-market setting public data can be shared on a global level Data maintenance needed to harmonise between different local solutions

Global source of PhPID (ISO 11616) Single database containing global validated PhPID Limit unnecessary data redundancies Validation service through well defined concise API International working group oversees assignments Business rules based on the IDMP algorithm for PhPID

Validation/ change request services International working group Validation without issues Local PhPID assignment pre-market Problem Validation UMC validation team Global source of PhPID Global source of PhPID Expert team Escalation Assignment Assignment solved How could global PhPIDs be maintained? Customer/User User Support Validation Manager Service Delivery Manager User Issue Type? PhPID request Solve issue User questionFeedback Expert team What problems can there be? Substance name not in global database – needs to be verified, added or mapped Dosage form not in global database Different countries using different controlled vocabularies – mapping needed PhPID algorithm needs to be updated to capture a new case Use data Browsing PhPID data Local PhPID marketed drugs

Global service provider - undertaking Governance International working group Validation team Technical support Global database of PhPIDs Setting the Maintenance framework & validation process Regular reviews Validation according to agreed process Validate to ensure global PhPID used Responding to questions and handling issues Perform regular data updates including cross- references needed for pharmacovigilance Ensure the availability of the service from a technical perspective User/API administration Oversee assignments Escalating conflicts Decide on updates of algorithm Escalates to ISO for updates of the standard

Forum for international collaboration EMA and FDA already started on joint projects Suggested to move into IPRF (International Pharmaceutical Regulators Forum)

One goal In our role as a WHO Collaborating Centre, we adhere to WHO policies and work in close liaison with WHO headquarters. We provide scientific leadership and operational support to the WHO Programme for International Drug Monitoring. We share the WHO’s goal of better health for all, but are organisationally and professionally distinct from the WHO itself. A WHO Collaborating Centre