# Assign a Rule Set to an Agency

Assign a <a href="/en/lr/01252/">Safety Rule Set</a> to an Agency to automatically generate Submissions to that Agency when a Case matches a reporting rule.

For more information on how the rules engine automatically generates Submissions for agencies, see <a href="/en/lr/01256/">Understand Reporting Rules</a>.

To reduce chances of errors in regulatory reporting, we recommend that you create validation rules to ensure the appropriate regulatory rule set is assigned to each regulatory agency. <a href="/en/lr/46866/">Configuring Record Validation Rules</a> provides more information about configuring validation rules on Vault objects. 

## Add Reporting Rules to a Custom Agency

<a href="/en/lr/01213/">Manage Organizations</a> provides information on configuring new Agency Organizations.

1. Navigate to **Business Admin > Objects > Organizations**.
2. Open the Agency to which you want to add a reporting rule, and then select **Edit**.
3. In the **Submission Rules** field, select the reporting ruleset to use. <a href="/en/lr/01252/">Standard Reporting Rule Sets</a> provides more information on the available rulesets.
4. Select **Save**.

**After You Finish**

For electronic submissions, configure a <a href="/en/lr/01458/">Custom AS2 Connection</a>.

For manual submissions, configure a <a href="/en/lr/01202/">Manual Transmission Profile</a>. 

## Add Reporting Rules to the FDA

To enable the FDA reporting rule: 

1. Navigate to **Business Admin > Objects > Organizations**.
2. On the _Organizations_ page, open the **FDA** record.
3. Select **Edit**.
4. In the **Submission Rules** field, select **FDA ICSR Reporting Rule Set**.
5. Select **Save**.

**After You Finish**

For post-market submissions to the FDA ESG, configure the <a href="/en/lr/01451/">FDA AS2 Connection</a>. 

For manual study submissions to the FDA, configure the FDA Manual Transmission Profile.

## Add Reporting Rules to the EMA 

To enable the EMA reporting rule: 

1. Navigate to **Business Admin > Objects > Organizations**.
2. On the _Organizations_ page, open the **EMA** record.
3. Select **Edit**.
4. In the **Submission Rules** field, select **EMA ICSR Reporting Rule Set**.
5. Select **Save**.

**After You Finish**

Configure the <a href="/en/lr/01452/">EMA AS2 Connection</a>. 

## Add Reporting Rules to the PMDA 

To assign the PMDA reporting rule set:

1. Navigate to **Business Admin > Objects > Organizations**.
2. On the _Organizations_ page, open the **PMDA** record.
3. Select **Edit**.
4. In the **Submission Rules** field, select **PMDA ICSR Reporting Rule Set**.
5. Select **Save**.

**After You Finish**

Configure the <a href="/en/lr/01455/">PMDA AS2 Connection</a>.