Interchange mapping updates

The new ICH-ICSR V2.2 MESSAGE TEMPLATE - FDA profile is provided with the default export mappings. You can use the new profile to submit reports for both combination and non-combination products.

Export mappings for FDA E2B(R2) 2.2 DTD profile are derived using FDA E2B(R2) 2.1 DTD profile. However, the following updates are made to the FDA E2B(R2) 2.2 DTD profile:

• New elements are provided with export mappings and allowed values.
• Changes to the mapping logic for the existing elements in E2B(R2) 2.1 DTD profile.

Import Mappings are not provided for the FDA E2B(R2) 2.2 DTD profile in this release.