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SRP (Safety Reporting Portal) in USA as per FDA
Q: What is SRP in USA as per FDA?
A: The Safety Reporting Portal (SRP) streamlines the process of reporting product safety issues to the Food & Drug Administration (FDA) and the National Institutes of Health (NIH).
Q: Who can submit a case report in SRP?
A: Manufacturer, health care professional, researcher, public health official, or concerned citizen can report via SRP Portal.
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Q: Reports You Can Submit Through this Portal?
A: FDA safety issues involving:
- Marketed human drug and biologics
- Human or animal reportable foods
- Animal drugs
- Animal foods
- Tobacco products
- Dietary supplements
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Q: Who Should Submit a Safety Report?
A: Organizations and people in certain professional roles, such as the following, may be required by law to submit safety reports under some circumstances.
- Food Manufacturers, Processors, Packers, and Holders
- Researchers
- An applicant of an approved drug product or a manufacturer, distributor or packer listed on the label of any marketed drug product
- Drug Manufacturers
- Sponsors, sponsor-investigators of investigational drugs and biologics
- Dietary supplement manufacturers, packers, and distributors
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Q: Who can report to SRP voluntarily?
A: Voluntary reporting includes healthcare providers, public health officials, and other professionals, as well as consumers and concerned citizens, may voluntarily submit reports if they encounter safety issues with a product and/or unanticipated harmful effects that they believe are related to a product.
Q: Is it required to attach copy of a MedWatch 3500A form/CIOMS form to a submitted SRP case report?
A: No, There is no need to attach a copy of a MedWatch 3500A form/CIOMS form to a submitted SRP case report.
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Q: To whom we can contact regarding reporting related issues via SRP?
A: For reporting related issues: contact FAERSesub@fda.hhs.gov
Q: How to submit FUs via SRP?
A: If MAH would like to submit a follow up ICSR, select the most recently submitted ICSR for that case and select the follow up option to add or correct information.
If your previous ICSR was submitted on a paper FDA form 3500A/CIOMS form, you must use the same Manufacturer Control Number (MCN) in order to create a follow up report using SRP. Do not add Version numbers to the MCN.
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Q: What is format of attachments in case report submission in SRP?
A: When adding an ICSR, select the “Attachments” menu item from the left side of the page. Attachments must be submitted as PDF documents. ICSR attachments can only be submitted with ICSR. MAH cannot submit attachments separately from an ICSR.
Q: What is size limitation of attachments in SRP?
A: SRP can receive attachments up to 25MB. If a larger attachment is to be submitted, then it is recommended you contact FAERSesub@fda.hhs.gov
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Q: Is it possible to submit an attachment for already submitted case earlier?
A: To submit an attachment to a previously submitted ICSR. Submit a follow-up ICSR with the attachment.
MAH need to submit a follow-up ICSR to make correction to already submitted report. MAH need to submit a follow-up ICSR to nullify an already submitted report. This need to be indicated in the case narrative that you are nullifying the ICSR and the reason for the nullification.
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Q: How to enter a compounded product as a primary suspect product in SRP?
- A: Steps as follows
- Navigate to the Primary Suspect Product screen
- Under the “Primary Suspect Product Information” section select “Product name” as “Other” from the drop-down list.
- Please describe” field will appear below the “Product name” field.
- Enter the compounding product name in the “Please describe” field.
- Enter the value COMP99 for the field “Drug authorization number (Enter COMP99 for compounding product).
- For a multiple ingredient compounded product, list each ingredient individually following the steps above. Do not list all the ingredients on line in a concatenated fashion.
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Q: How to enter a primary suspect product that is not in the “Product name” drop down list?
- A: Steps s follows
- Navigate to the Primary Suspect Product screen.
- Under the “Primary Suspect Product Information” section select “Product name” as “Other” from the drop-down list.
- Please describe” field will appear below the “Product name” field.
- Enter the product name in the “Please describe” field
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Q: Is it ok for MAH to have ESH and SRP?
A: MAH is not allowed to have ESG and SRP at the same time
Q: SRP Portal account activation Process?
- A: Portal account activation follows as below
- To submit via SRP, MAH must have an account to access the portal site
- Contact FAERSESUB@fda.hhs.gov to advise FDA of your intent to begin submitting via the SRP.
- It is highly recommended that both Product Name and Product Active Ingredient (PAI) be provided for completeness of product information.
- Submit a copy of the SPL (Structured Product Label) for the registering product
- Account will be activated in about 7 to 10 business days.
- To submit via SRP, MAH must have an account to access the portal site
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Q: How MAH knows whether SRP Activated or not?
A: MAH will be notified via email with the subject line “SRP Account Activation” that will include the web link to the SRP portal along with account information. After receiving this email, account will be considered active and may begin submitting reports.
Q: How frequent SRP Portal password need to be renewed?
A: The SRP password needs to be renewed and/or changed every 120 days.
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Q: Dormant accounts will be deactivated?
A: The not used SRP account during the past 365 days or MAH cannot enter the reporting portal, the account may be deactivated.
Q: What is time out for SRP account session?
A: SRP session will timeout after 20 minutes if no activity is performed. Log in is available immediately after the timeout however you will not be able to access your unfinished report for 20 minutes.
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Q: Who can be contacted for technical problems?
A: For all technical problems (account reactivation, disabling the account, password reset) MAH need to contact SRPSupport@fda.hhs.gov
Q: How to add or remove additional products to account?
A: Please contact FAERSesub@fda.hhs.gov to add or remove additional products to the Group Lead account.
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Q: What is functionality of the Group Lead and Group Members?
- A: The functionality of the Group Lead and Group Members as follows
- It is the same within SRP (Case processing).
- Group lead may view all reports initiated and/or submitted by a Group Member.
- Group lead is the Point of Contact (POC) for all inquiries related to SRP.
- Group Members may only view reports they have initiated; however they can view all submitted reports
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