4.1. Requirements and format for RAID designation application
An applicant shall submit a RAID designation application to SFDA. Companies seeking a RAID designation should complete the RAID designation application form (see Appendix 2), with supporting documents indicating how the product fulfils the criteria of designation.
The application format must be well prepared in a modular format consistent with the electronic Common Technical Document (eCTD) to facilitate the preparation of later MAA submission, refer to Appendix 3 for eCTD modules and requirements.
4.2. Application process
• Step 1: Submission
- A formal request for RAID designation must be submitted through email (Designation.Drug@sfda.gov.sa), accompanied by the designation application form and details showing that the product within the scope of the eligibility criteria and satisfies the requirements.
- Additionally, the application file of supporting documentation must be in the electronic common technical document (eCTD) format and submitted to SFDA on electronic media (i.e. CD) to the drug sector.
• Step 2: Validation of the application
- Following the submission, the application will be validated, and notification via email will be given within 15 working days of whether the RAID designation application is within the scope and that the format and content are adequate to support the evaluation of the request.
- If validation issues are raised, SFDA will notify the applicant via email to address the deficiencies and resubmit the updated application within 90 days.
o Applicants are allowed to ask by email for a timeframe extension to address deficiencies if needed.
• Step 4: Evaluation
- Once validated, the application will undergo evaluation by Multidisciplinary specialist evaluation areas across SFDA for 40 working days.
- If deficiencies, comments, or additional information related to the application file are raised during the evaluation, the applicant will be notified via email to address that and update the application within 90 days.
- Applicants are allowed to ask by email for a timeframe extension to address deficiencies if needed.
• Step 5: SFDA Decision on designation
- Once evaluation on the basis of preclinical and clinical data available on the product is complete, SFDA will issue a final decision letter through Designation.Drug@sfda.gov.sa within 5 working days.
- If the application meets all requirements, the application will be granted the RAID designation.
- If the application does not meet all requirements, the application will be rejected.
o The applicant has the right to appeal against decision in accordance with the Policy of Appeal to Drug Sector Decisions.
Following the RAID designation, the applicant completes the clinical development with designation incentives and should apply for a Clinical Trial Application (CTAp) via the Saudi Clinical Trial Registry (SCTR), and Saudi Drug Registration (SDR) System within 30 days. Please refer to SFDA Regulations and Requirements for Conducting Clinical Trials on Drugs.
Figure 2: Application for RAID designation flowchart.
WD: Working Day, CTAp: Clinical Trial Application, SCTR: Saudi Clinical Trial Registry System, SDR: Saudi Drug Registration system.