ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
ISSN 2383-9457 (ONLINE)
| South Korea | Japan | Singapore | Europe Union | |
|---|---|---|---|---|
| Legal basis | Yes (Pilot) | Yes | No (Pilot) | No (Pilot) |
| Target | Prescription Medicines | Prescription Medicines | All Medicines (Prescription/Non-prescription) | All Medicines (Prescription/Non-prescription) |
| Package leaflet type | Package Leaflets (target audience not considered) | Package Leaflets for Healthcare Professionals | Package Inserts (for HCP |
Summary of Product Characteristics (SmPC) (for HCP |
| Distribution method | E-label Only (Paper Inserts Provided upon Request) | E-label Only (Paper Inserts Provided upon Requests and Certain Conditions) | E-label Only | E-label & Paper Package Leaflets |
| Replacing Paper Inserts | Possible | Possible | Possible | Impossible |
| E-label developing entity | Marketing Authorization Holder | Marketing Authorization Holder | Marketing Authorization Holder | Marketing Authorization Holder |
| Distribution Platform | Marketing Authorization Holder website | PMDA website | Marketing Authorization Holder website | EMA website (Product Lifecycle Management Portal) |
*Note: The United States is excluded from this table because although there have been past discussions about adopting e-labels, no concrete action has been taken.
*HCP: Healthcare Professionals