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RAID : Research and Investigational drugs, including biologics, that is used in a clinical investigation and not yet authorized by SFDA
The name" Rā’id رائد” reflects the essence of pioneering, symbolizing innovation and development of investigational drugs, particularly those with clinical studies conducted within Saudi Arabia.
RAID designation Application : It is an application submitted to obtain the Saudi Food and Drug Authority (SFDA) designation for RAID to enable access to incentives when conducting research and developing (R&D) in Saudi Arabia, including running Clinical trials. RAID designation aims to expedite the development and review of investigational drugs.
Clinical Trials : Each research (study) that concerns with collecting and analyzing information, which related to volunteers and patients to reach general knowledge that could be applied on other patients according to the mechanism of diseases occurrence, diagnosis, its spreading, or treatment.
Sponsor : Individuals, companies, institutes, establishments, or organizations, which take the responsibilities of starting, managing, and financing the clinical trial.
For the purposes of this guidance, "applicant" and "sponsor" are considered synonymous.
Saudi Clinical Trials Registry (SCTR) : It is an electronic system with electronic database which includes an official records of all drugs clinical studies in Saudi Arabia to ensure that all received information are accurate and completed along with publishing the minimum amount of information about the clinical trials, which is globally agreed, so it can be viewed by public.
Biologics : Medicinal products derived from a variety of natural sources or produced by biotechnology methods and other cutting-edge technologies. They include a wide range of products such as vaccines, blood and blood components, allergenic, advanced therapy medicinal products (ATMPs), recombinant proteins and biosimilar.
Drug : An article intended for use in the diagnosis, cure mitigation, treatment, or prevention of disease and which is intended to affect the structure or function of the body.
Common Technical Document (CTD) : An international harmonized format for submissions for approval of pharmaceuticals. The CTD provides a standardization of the presentation of the content.
Phase I studies : The clinical studies which are conducted on humans for the first time to test the safety of the product.
Phase II-III studies : Clinical studies that conducted on the patients to test product’s safety and efficacy.
The Research and Investigational Drugs (RAID) designation is one of the Saudi Food and Drug Authority (SFDA) designation programs that promote conducting Research and Development (R&D) in Saudi Arabia. It aims to accelerate the development and regulatory review of drugs and biologics, expediting the availability of promising new therapies in Saudi Arabia.
The purpose of this guidance is to outline the procedures and requirements for submitting a RAID designation application, and encouraging the development of innovative products for effective treatment in Saudi Arabia.
1.1. Importance of Research and Innovation in Saudi Arabia
R&D in the pharmaceutical sector plays a pivotal role in advancing public health, driving innovation, and strengthening national drug security. In Saudi Arabia, R&D is essential in supporting the Kingdom’s vision for a knowledge-based economy and self-sufficiency in high-value healthcare products. By fostering scientific discovery and accelerating the development of new therapies, pharmaceutical R&D enables the creation of tailored, effective treatments that address both local and global health priorities. It also supports the growth of the biotechnology ecosystem, attracts strategic investment, and positions the Kingdom as a regional hub for pharmaceutical innovation. RAID program has been launched to promote R&D ecosystem by providing regulatory frameworks that support innovation, facilitating clinical trials, and promoting collaboration between academic institutions, industry, and government bodies. Through RAID, SFDA ensures that promising research can be efficiently translated into safe, effective, and accessible medical products
1.2. Scope
This guidance applies to applicants seeking SFDA designation for investigational products that are under development, not yet authorized in Saudi Arabia, and intended for future submission as marketing authorization application (MAA) to the SFDA. Designation applications may be submitted during any clinical phase (phase I, II, or III) of drug development.
1.3. Criteria for RAID designation
For an application to be eligible for RAID designation, it must meet all of the following criteria:
1. The product is under development and has not yet been authorized for marketing by any other regulatory authorities globally.
2. Innovativeness of the products.
3. A clinical trial for the investigational product must be intend and committed to be conducted in Saudi Arabia.
The RAID designation is voluntary; however, applicants must submit a well-justified request demonstrating that the application meets all eligibility criteria for RAID designation.
1.4. Related documents
This document should be read in conjunction with the following documents:
- SFDA Regulations and Requirements for Conducting Clinical Trials on Drugs.
- SFDA Procedures for Importation and Exportation of Pharmaceutical Products.
- SFDA Clearance Conditions and Requirements.
- Guideline for Good Clinical Practice.
- Guideline on strategies to identify and mitigate risks for first-in human and early clinical trials with investigational medicinal products.
- General Considerations for Preclinical Studies Submissions.
- Guidelines for Chemical and Pharmaceutical Quality Documentation of Small Molecules Investigational Product in Clinical Trials. (draft)
- Guideline on Submission of Chemistry, Manufacturing, and Control (CMC) Information for Cell-based Clinical Trial Applications.
- Guidance on Submission of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Clinical Trial Applications. . (draft)
- International Council for Harmonization (ICH) relevant guidance documents.
- Contract Research Organization Guideline.
The following incentives aim to strengthen collaboration between SFDA and applicants, encourage the conduct of clinical studies within Saudi Arabia, facilitate the expedited introduction of innovative product to the Saudi market, and deliver tangible benefits to patients and society. Receiving the RAID designation entitles the product to various incentives and benefits to support its development and review:
- SFDA dedicated contact point: assigning a product manager who will coordinate the support offered throughout the RAID application.
- Pre-designation meeting: An introductory meeting held with a multidisciplinary group of experts from SFDA, during which preliminary scientific and regulatory guidance is provided for RAID designation requirements.
- Scientific guidance: Scientific advice and Regulatory support to help applicants align their development strategies with SFDA requirements.
Furthermore, there are opportunities for frequent interactions, including meetings throughout the product development, with SFDA and relevant stockholder for a designated product.
- Pricing rules: SFDA will provide support in the pricing procedures of investigational product. This will include approving meeting requests and providing consultations on pricing rules, conducting parallel review alongside the registration review, and initiating early discussions with applicants regarding pricing.
- Guidance on regulatory pathways: SFDA will further support the development through the potential for expediting assessment at the time of an application for marketing authorization (MAA), a drug that granted RAID designation is eligible for:
o Priority Review of MAA that reduces total performance target by 40%.
o Rolling submission of MAA as SFDA may consider reviewing portions of a MAA before the sponsor submits the complete application.
o Further support and incentives may be granted for RAID-designated products, such as product could be eligible for conditional approval if supported by clinical data.
SFDA provides support to sponsors planning RAID designation application through optional pre- designation meetings. The primary purpose of this meeting is to obtain SFDA preliminary assessment and feedback on a planned RAID designation application, especially if a sponsor’s inquiries are not fully addressed by guidance documents and other publicly available resources. The pre-designation meeting will also effectively assist sponsors in preparing to submit complete RAID designation applications.
3.1. Meeting request
SFDA encourages sponsors to request a pre-designation meeting. The request for a pre-designation meeting must be submitted using the request form available in Appendix 1. The form includes the following information and supporting documents:
- Description of the product (information on the product and its stage of development).
- A proposed agenda (list of specific questions to be addressed, such as those relating to preclinical, clinical, quality, and manufacturing requirements), including estimated duration needed for the discussion of each agenda item.
- Relevant details of the proposed clinical trials to be conducted and supporting documentation, which should be sufficiently extensive to provide the necessary background information.
- A list of planned attendees from the sponsor’s organization, including their names and titles, if applicable.
- Proposed meeting dates and time.
If the submitted documents are insufficient when a request is made, SFDA may request additional data or clarification on the submitted information.
3.2. Process for pre-designation meeting
The pre-designation meeting process consists of the following steps:
1. Submission: Submit a request for pre-designation meeting, accompanied by complete meeting request form and supporting documentation via email (Designation.Drug@sfda.gov.sa). It is recommended to submit the request at least one month prior to the proposed meeting date to manage timeframes and resources.
2. SFDA response to Meeting Request: Upon receiving the pre-designation meeting request, the SFDA validates and reviews the request, and then responds within 30 working days:
- If the request meets all requirements, it will proceed to the next step.
- If any deficiencies are identified, the SFDA will notify the applicant of the required corrections. The applicant must address the deficiencies and resubmit the application form through the assigned email within 60 working days.
3. Meeting Scheduled: SFDA product manager will notify the applicant via email with details on meeting arrangements (a mutually acceptable time and date), the format of the meeting (in person face-to-face meeting or virtual meeting).
- In general, meetings will be organized within 20 working days from the end of the previous step.
4. During the meeting
- The meeting will be chaired by SFDA staff, and the duration will be determined by SFDA based on the meeting agenda.
- Only the materials that have been included in the request form should be presented at the time of meeting (if important new information becomes available, send an email with updates to the SFDA at least 5 working days before the meeting).
5. After the meeting
- The applicant is requested to record the meeting minutes and to be sent as a Word document to the SFDA within 10 working days following the meeting for agreement.
- The SFDA may comment on the recorded minutes if necessary, and the final version is returned to the applicant within 10 working days. If no comments are raised, the SFDA will acknowledge the meeting record within 10 working days of receiving the meeting minutes.
Figure 1: Flowchart for the pre-designation meeting request. WD: working day.
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.
- RAID designated drug under development may/should continue through a Marketing Authorization Application (MAA) after completion of the trial. The pharmaceutical company can submit the MAA to SFDA in accordance with SFDA regulations for drugs approval.
- To take full advantages, other tools supporting early patient access to therapy, include the Breakthrough Medicine Program, further application can be submitted by the end of phase 2 or at any time after if fulfilled the criteria.
Section A: Meeting Request Information
Meeting Objectives
Please state the specific objectives of the meeting briefly (e.g., clarify study designs, discuss CMC concerns, address regulatory questions).
Agenda
Propose a preliminary meeting agenda.
List of Attendees
Names and titles.
Proposed Meeting Dates
Provide at least three preferred dates (submission must be at least one month in advance).
Meeting Format
- In person face-to-face
- Virtual
List of Requested SFDA Participants
- Quality
- Pre-clinical
- Clinical
- Regulatory affairs
Section B: Applicant &innovative product Information
Applicant
Name:
Address:
Marketing Authorization Holder
Contact Person
Name: Title: Phone Number: Email Address:
SCTR Number
If applicable
Name of Drug
Include all available names: Trade, Chemical, or Code
Route of Administration
innovative product Type
- Biologic (Specify)
- New chemical
SRA innovative product Status
Clinical and regulatory status of innovative product in SRA
Phase of Clinical Investigation to Be Conducted
- Phase I trials
- Phase II trials
- Phase III trials
- Other
Description and Composition of innovative product
Mechanism of Action
Proposed Indication
Dosing Regimen, Including Concentration, Amount Dosed, And Frequency and Duration of Dosing If Known
Manufacturing Sites of Drug Substance and Product
Section C: Information Package
Pre-clinical
Provide sufficient nonclinical information to support proceeding to clinical trials
Clinical
Therapeutic area and indications proposed preclinical data supporting movements to clinical phase.
if available, scientific advice received from other regulatory authorities
CMC
Summary of related quality data
Section D: A List of Proposed Questions
For each question there should be a brief explanation of the context and purpose of the question.
Declaration: I confirm that all information provided is, to the best of my knowledge and belief, true, correct and complete. Furthermore, I will notify SFDA with any updates/change on the provided information immediately.
Name
Insert the name of the person submitting the request
Title
Insert title of the person submitting the request
Signature
Insert signature
Date
insert date of submission
Section I: Drug Information
Marketing Authorization Holder/ Study Sponsor
Authorized Contact Person
Drug Type
- New chemical (Specify)
ATC code
Strength(s)
Dosage Form(s)
Route(s) of Administration
Drug Substance Manufacturer(s)
Drug Product Manufacturer(s)
Description and Composition of Drug Product
Storage Condition(s)
Shelf life
Current global regulatory status including:
Application in other global expedited pathways (e.g. PRIME, BTD)
Compassionate/specials usage
Pending and refused marketing authorization applications
Granted marketing authorizations
Is the drug not authorized or under registration in Saudi Arabia?
- Yes (with evidence)
- No
Is the drug innovative with novel mechanism of action?
Local & International Patent Information
Is this indication for a rare disease (prevalence 5 in 10,000 individuals in Saudi Arabia)?
Does this product have an SFDA Orphan Designation for this indication?
Proposed MAA pathway
Section II: Clinical Trial Information
Study Title
Protocol Number
Study site(s)
Phase of Clinical trial to be conducted
SRA Clinical stages of development including:
Clinical trial phase
Global clinical trial registration number, if any (e.g. EudraCT, ClinicalTrial.gov)
Section III: Data package (eCTD)
Sequence No.
Sponsors should compile all necessary information and documentation required for the RAID designation application, including preclinical data, clinical trial protocols, manufacturing information, and safety monitoring plans. The submission should be prepared according to SFDA regulations and guidance documents in an eCTD format.
Module
Contents of submission
Module 1
Administrative information about the proposed trial should include:
Cover letter
Payment bill
RAID designation application form
All requirements set out in SFDA Regulations and Requirements for Conducting Clinical Trials on Drugs should be submitted in additional data section.
scientific advice by other regulators
Information on the experts (clinical, preclinical and quality)
Module 2
Contains summaries about the drug to be used in the proposed trial
Module 3
Contains supporting quality information in accordance with the applicable SFDA requirements in the following guidelines:
Guidelines for Chemical and Pharmaceutical Quality Documentation of Small Molecules Investigational Product in Clinical Trials.
Guidance on Submission of Chemistry, Manufacturing, and Control (CMC) Information for Cell-based Clinical Trial Applications
Guidance on Submission of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Clinical Trial Applications
Module 4
Preclinical data in accordance with the General Considerations for Preclinical Studies Submissions.
Module 5
Clinical data requirements:
Tabular listing of all studies related to the innovative product
Clinical Study Report (CSR) for completed trials, or Interim analysis if available.
Protocols of completed studies.
Current protocol including details of statistical analysis including all previous versions
Last update: 09 September 2025
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