To strengthen communication with applicants, the CDE also provides consultations related to review cases. If applicants have any questions about the deficiency letter, they can apply through the CDE's Drug Consultation Service Platform.

1. Application:
   (I) Applicants should fill out the Consultation Services Application Form:  path on the CDE's website, and select the “Review related consultation” from the general consultation and provide the TFDA case number or the CDE case number. 
   (II) Applicants should call or email the project manager for consultation service submission assistance after receiving a deficiency letter.
2. Acceptance:
   (I) After receiving the application, the CDE will confirm the consultation topic. If the topic is unclear or the materials are incomplete, the CDE will contact applicants to clarify the consultation topic and provide complete materials. 
   (II) If applicants cannot provide complete materials within two weeks, the case will be closed, and applicants will be asked to reapply. 
3. Response:
   (I) Written Reply
   (II) Face-to-Face Communication Meeting
   1. After the CDE accepts the case, it will schedule a consultation meeting with the applicant. After both parties confirm, a notification letter for the consultation meeting and a consultation meeting minute template will be sent to the applicant.
   2. Meeting Notes:
   (1) The consultation meeting is limited to 1 hour. To facilitate discussions during the meeting, if the applicant intends to present a briefing, the briefing should not exceed 10 minutes. 
   (2) Briefing content and materials must be provided 7 days before the meeting; late submissions will not be accepted.
   (3) The consultation meeting will not involve a pre-review or accept new consultation topics. 
   Note: The CDE reserves the right to decide the final response method.
4. Requirements for Applicants
   (I) Project managers will proactively contact applicants to discuss the online consultation service application form after applicants have completed and submitted it. Applicants must fill in the correct contact phone number and email address.
   (II) To provide precise and efficient consultation services, applicants should organize all difficulties encountered at the current stage and submit them at one time, avoiding multiple consultations.

The CDE website Drug Consultation Application