On August 14, 2023, PFDA issued FDA Advisory 2023-1881 announcing the Pilot Implementation of the FDA Customer Relation Management Information System (CRMIS). This new system aims to allow all stakeholders and the public to lodge inquiries, follow-ups, and other concerns through the PFDA contact website.

  • The following inquiries may be lodged through the new system:
  •   ●   Follow-up
  •   ●   Request
  •   ●   Product/system complaint
  •   ●   Payment status
  •   ●   Report of Violation

PFDA also provided guidelines for its users; the following are the key details:

All FDA-related concerns shall be lodged through the FDA CRMIS. The creation of an account and password is not necessary.

The CRMIS accepts a single request per online form. Multiple requests shall be lodged separately for ease of facilitation. The FDA will not process multiple requests per online form.

It is required for users to complete all the mandatory fields to ensure accurate and thorough information capture. Additionally, users have the option to upload supporting attachments like documents and screenshots if needed.

The user shall ensure that the CAPTCHA code is correctly entered; otherwise, the request shall not be processed.

The concerned FDA Center or Office shall respond to the submitted ticket using the official FDA e-mail address. The user shall lodge their reply to the FDA’s official e-mail address; otherwise, the response shall be deemed not received by the FDA.

The CRMIS shall not be used for the FDA’s marketing authorization applications and is strictly for receiving the types of inquiries enumerated above.

The FDA's response quality depends on the information given by the client or requestor. So, it's important to provide all relevant details accurately to help the FDA retrieve data effectively.

The pilot implementation started on August 28, 2023, and will be implemented until November 30, 2023. Further details will be announced in the future.




FDA Webpage

CRMIS Webpage