Configure the EDI and Report tabs for EMA and PMDA

The following table lists and describes the fields on the EDI and Report tabs to be set up for the EMA and PMDA profiles:

Agency Identifier	EVCTM or EVPM	PMDA
Secondary Agency/Department Identifier	Not applicable	Not applicable
File type	XML	XML
Company identifier	As applicable	As applicable
Message Profile	ICH-ICSR V3.0 MESSAGE TEMPLATE - EMA	ICH-ICSR V3.0 MESSAGE TEMPLATE - PMDA
ACK Profile	ICH-ICSR V3.0 ACKNOWLEDGMENT TEMPLATE - EMA	ICH-ICSR V3.0 ACKNOWLEDGMENT TEMPLATE - PMDA
Suppress ACK transmission	Marked	Unchecked (Default)
Transmit ICSR Attachments	Marked	Marked
Attachment Classification	As applicable	As applicable
Allowed attachment file size (in MB)	15 MB	15 MB
Allowed report size (in MB)	100 MB	AS1: 10 MB AS2: 50 MB
Incoming folder	Refer to the Configure Folders chapter	Refer to the Configure Folders chapter
Outgoing folder	Refer to the Configure Folders chapter	Refer to the Configure Folders chapter
ICSR Attachment Outgoing Folder	Not required	Not required
File Name	As required, for example: EVPM_########.xml	As required, for example:PMDA_########.xml
Method	E2B EDI gateway	E2B EDI gateway
Apply EMA Masking Rules	Marked	Not Marked

Note:

You can check the Apply EMA Masking Rules checkbox to apply EMA masking rules when you submit ICSRs to EudraVigilance (EVPM and EVCTM).