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The Saudi Food and Drug Authority (SFDA) has launched an initiative that offers applicants the opportunity to obtain scientific and regulatory advice in areas related to human medicinal products, which are in the remit of the SFDA.
This guideline provides an overview of the procedure for obtaining SFDA scientific and regulatory advice, and gives guidance to the applicants in preparing the request.
The legal basis for this document is the Law of the Saudi Food and Drug Authority.[1] Executive duties mentioned in Article 5 (14): "Conducting research and studies and providing consultancy services relating to its work and activities and cooperating with companies, organizations, universities, scientific research centers, and other institutions that engage in similar activities."
[1] Law of the Saudi Food and Drug Authority Royal Decree No. M/6 February 13, 2007.
SFDA provides scientific and regulatory advice for applicants on all areas relating to human medicinal products. SFDA advice may be provided at any time before or after the authorization of a medicinal product.
Scientific Advice is provided at any stage of the development in the form of prospective advice. It covers questions related to the quality aspects, the design and conduct of non-clinical investigations and clinical trials of human medicinal products, and aspects related to pharmacovigilance and the risk management plan.
Regulatory Advice may also be requested on issues related to procedural aspects of marketing authorization application, variation, or any regulatory issues that are either not covered by the relevant guidelines or require further interpretation. It is not within the scope to provide a pre-assessment of data submitted for SFDA approval.
SFDA scientific and regulatory advice may be requested on such questions related to:
- Quality aspects (e.g., manufacturing, chemical, pharmaceutical and biological testing of the medicine);
- Clinical aspects (e.g., appropriateness of studies in patients or healthy volunteers, clinical development program for new chemical entity or biological product, Bioequivalence studies);
- Preclinical aspects (e.g., toxicological and pharmacological tests designed to show the activity of the medicine in the laboratory);
- Pharmacovigilance aspects (e.g., results of detected signals for drug safety, risk management plans, post-marketing study protocol on safety and/or efficacy of medicine, Periodic safety update report)
1. This document shall be read along with other regulations, procedures, guidelines, circulars and decisions issued by SFDA.
2. In the event of any conflict or inconsistency between the provided service "SFDA advice" and SFDA regulations and guidelines, the Authority laws and regulations, executive regulations, guidelines, specifications, and requirements shall prevail.
3. The answer given is based on the question and documentation submitted, and relevant SFDA regulations at the time of processing the advice application, without prejudice to regulatory and scientific developments.
4. Scientific and regulatory advice is optional and independent of the process for applying for marketing authorization, and it is not provided for screening the submission dossier. To ensure the correctness of the application type and the completeness of the dossier, please refer to relevant SFDA guidelines.
5. Applicants seeking consultation must note that any advice given is not legally binding with regard to any future marketing authorization application of the product concerned, either on the SFDA or on the applicant.
The request for SFDA advice needs to be made in writing using the application form available in annex 1, including the following information and supporting documents to facilitate timely response and to enable efficient advice. However, it should be noted that the SFDA will accept a limited number of advice applications per month, taking procedural efficiency and resource availability into consideration.
- Description of the product (including product name, indications, stage of development, proposed regulatory pathway, where relevant).
- A proposed agenda with the issues to be discussed (list of specific questions to be addressed, such as those relating to non-clinical, clinical, quality, and manufacturing requirements), including estimated time needed for discussion of each agenda item.
- Comprehensive information relevant to the questions raised and supporting documentation, which should be sufficiently extensive to provide the necessary background information (including the applicant's explanation of the context and purpose of the question).
- Proposal for the meeting format: in-person, virtual, or written response.
- A list of planned attendees from the applicant’s organization, including their names and titles, if applicable.
- Proposed meeting dates and time (e.g., within eight weeks of receipt of the request, morning or afternoon).
If the submitted documentation is insufficient when a request is made, SFDA may seek additional data or clarification on the information submitted before providing advice.
There are three formats: In person face-to-face, virtual, and WR, as follows:
1. In-person face-to-face meeting: Attendees from the SFDA and the applicant participate in person at the SFDA.
2. Virtual meeting: Attendees participate remotely via a virtual meeting platform (e.g., Zoom).
3. Written Response (WR): Written responses are sent to applicants instead of meeting formats described above.
1. Submission: The Applicant submits a request for advice, including the request form and supporting documentation, via email (email address will be determined later).
2. Validation: The request will be validated by SFDA with regard to the content of the request, including the scope of the questions. All information provided will be treated as confidential.
- Following receipt, the request will be assessed, and notification via email will be given within 10 working days of whether the request for the advice has been accepted and which format is appropriate to conduct the advice.
- If a more extended review is necessary, SFDA will inform the applicant of the expected response timeline, depending on the volume received and within available resources.
- If validation issues are raised, SFDA will notify the applicant via email to update the request within the required deadline to avoid canceling the request.
3. Conducting of the advice:
o In case of in-person and virtual meetings:
Once the request is accepted, SFDA will notify the applicant via email with details on meeting arrangements (date and time), the venue of the meeting, and the expected SFDA participants. A meeting date will be mutually agreed upon for both parties.
- In general, meetings will be organized within 20 working days from acceptance of the request.
- The meeting will be chaired by SFDA staff.
- At the beginning of the meeting, the applicant will be asked to provide a brief presentation outlining topics to be discussed (10-15 minutes).
- The applicant is requested to record the meeting minutes and to be sent as a Word document to the SFDA within 5 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 questions cannot be answered conclusively during the meeting, SFDA will provide its written opinion following the meeting when sending the adopted final advice letter via email.
o Written Response (WR)
If a written response is requested and deemed appropriate, the SFDA will notify the applicant of the date it intends to send the written response once validated.
- Written advice will be issued by email within 50 working days following validation of the request.
4. Final advice:
SFDA will send the adopted final advice letter to the applicant via email within 30 working days following the meeting.
- If the applicant requires any subsequent clarifications, these are limited to the issues discussed and must be sent by email within 10 working days after receipt of the final advice (whether meeting or WR). The SFDA will provide clarification within 14 working days.
The advice given is not legally binding with regard to any future marketing authorization application of the product concerned, either on the SFDA or on the applicant. However, Advice will be provided in good faith, but circumstances could change over time. In some cases, e.g., due to scientific developments, an alternative approach to that previously advised may become more appropriate.
Details on all fees will be determined later, upon the issuance of the adopted version. However, SFDA will charge a fee for scientific and regulatory advice, which varies depending on the scope of the advice, i.e., clinical, preclinical, or quality aspects.
It should be noted that a significant fee reductions and a full waiver can be apply for certain types of medicines and applicants, including fee reductions for enterprises fostering biologics localization in Saudi Arabia, and fee reductions for advice applications concerning Advanced Therapies Medicinal Products (ATMPs), and investigational drugs.
Request Form for SFDA Scientific and Regulatory Advice
Please, send the completed request form and supporting documents to the email (email address will be determined later).
All the fields are compulsory. If any field is not applicable or no information is there to be furnished, write 'Not applicable' or 'N/A'. If any field is left unfilled, such an application will be treated as incomplete/invalid and may be rejected summarily.
Last update: 08 July 2025
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