The KSA’s Key Pharmaceutical Regulatory Developments in 2025

14 min 57 sec February 6, 2026 (Edited)

Written by

Christina Sochacki

Senior Counsel

c.sochacki@tamimi.com View LinkedIn Profile

The life sciences regulatory landscape in Saudi Arabia continued to evolve in 2025. Staying on top of the updates and new regulations, circulars, and guidance from the Saudi Food & Drug Authority (SFDA) is not a passive exercise; things are changing very quickly.

Below, we summarise the key new or updated pieces of SFDA guidance issued in 2025 which are pertinent to pharmaceuticals, biologics, biosimilars, and other medical products in the KSA.

Guidance on Submission of Chemistry, Manufacturing, and Control Information for Human Gene Therapy Clinical Trial Application

(V. 1 – New Document, DS-G-132-V01/251101)

As the SFDA continues to update its guidelines to reflect internationally recognised principles and best regulatory practices, new guidance has been issued to address the regulatory requirements for chemistry, manufacturing, and control (CMC) information in human gene therapy clinical trial applications. The guidance seeks to ensure that such products meet appropriate levels of quality and safety for clinical studies.

Human gene therapy products are classified as biological products in the SFDA Guideline on the Classification of Advanced Therapy Medicinal Products. Any clinical trial application, including clinical trials for gene therapy products, is required to describe the CMC information for the investigational product, including the drug substance and the drug product.

Sections are included regarding ex-vivo genetically modified cells, such as chimeric antigen receptor T-cell therapy products, which are regulated as gene therapy products under the SFDA’s existing framework for biological products.

Economic Evaluation Studies Guidelines

(V. 1.1 – New Version, DS-G-113-V1.1/240111)

In July 2024, the SFDA issued the first economic evaluation studies (EES) guidelines, with phased implementation until July 2025. The SFDA uses EES to determine the added value over the current standard of practice in Saudi Arabia’s healthcare system. This guidance applies to all human pharmaceutical products undergoing pricing procedures, including registration, price re-evaluation, and renewal.

This version 1.1, issued on 21 October 2025, introduces a new section outlining exemption criteria from EES submission. Medicinal products may be exempt if they meet one or more of the following criteria:

• the product is classified as a generic or biosimilar;
• the product is innovative and biological, with registered generic or biosimilar alternatives; or
• the product is classified as over-the-counter.

Approach of Dealing with Patents When Registering Generic Drugs in SFDA

(V. 2 – New Version, DS-REQ-089-V02/221128)

In cooperation with the Saudi Authority for Intellectual Property (SAIP), the SFDA has updated this guidance. The timeline for submitting a freedom to operate letter has been extended to 24 months prior to patent expiry. Registration of the generic product will still only occur once the patent has expired.

Innovator companies must include a copy of the patent document issued by SAIP within the registration file. If unavailable at submission, it must be provided upon issuance. This requirement also applies to products protected by patents issued by the Gulf Cooperation Council Patent Office.

If the innovator company claims patent infringement by a generic product, the matter may be submitted to the Commercial Court. The SFDA will comply with any final and enforceable judgment issued by the competent judicial authorities.

Guideline on Good Pharmacovigilance Practices

(V. 4 – New Version, DS-G-008-V4.0/150527)

This updated guidance introduces several clarifications and changes, including:

1. clearer responsibilities for applicants and marketing authorisation holders (MAHs);
2. stricter qualification requirements for the qualified person responsible for pharmacovigilance;
3. a new Annex III addressing joint Direct Healthcare Professional Communications (DHPC); and
4. updated requirements relating to the format of educational materials.

The life sciences regulatory landscape in Saudi Arabia continued to evolve in 2025. Staying on top of the updates and new regulations, circulars, and guidance from the Saudi Food & Drug Authority (SFDA) is not a passive exercise; things are changing very quickly.

Below, we summarise the key new or updated pieces of SFDA guidance issued in 2025 which are pertinent to pharmaceuticals, biologics, biosimilars, and other medical products in the KSA.

Guidance on Submission of Chemistry, Manufacturing, and Control Information for Human Gene Therapy Clinical Trial Application

(V. 1 – New Document, DS-G-132-V01/251101)

As the SFDA continues to update its guidelines to reflect internationally recognised principles and best regulatory practices, new guidance has been issued to address the regulatory requirements for chemistry, manufacturing, and control (CMC) information in human gene therapy clinical trial applications. The guidance seeks to ensure that such products meet appropriate levels of quality and safety for clinical studies.

Human gene therapy products are classified as biological products in the SFDA Guideline on the Classification of Advanced Therapy Medicinal Products. Any clinical trial application, including clinical trials for gene therapy products, is required to describe the CMC information for the investigational product, including the drug substance and the drug product.

Sections are included regarding ex-vivo genetically modified cells, such as the chimeric antigen receptor T-cell therapy product, an advanced therapy medicinal product that is regulated as a gene therapy under the SFDA’s existing framework for biological products.

Economic Evaluation Studies Guidelines

(V. 1.1 – New Version, DS-G-113-V1.1/240111)

In July 2024, the SFDA issued the first economic evaluation studies (EES) guidelines, with phased implementation until July 2025. The SFDA uses EES to determine the added value deserved over the current standard of practice utilised in Saudi Arabia’s healthcare system. This EES guidance applies to all human pharmaceutical products undergoing pricing procedures, including registration, price re-evaluation, and renewal in the SFDA.

This new version 1.1 of the guidelines, issued on 21 October 2025, includes a new section that outlines the exemption criteria from EES. Medicinal products will be exempted from submitting EES if they met the following criteria:

• product classifies as generic or biosimilar;
• product is innovative and biological, with generic or biosimilar alternatives registered; and
• product classifies as over the counter.

Approach of Dealing with Patents When Register Generic Drugs in SFDA

(V. 2 – New Version, DS-REQ-089-V02/221128)

In cooperation with the Saudi Authority for Intellectual Property (SAIP), the SFDA has updated this guidance. Previously, the generic company had the right to apply for the registration of a generic product of an innovative product without submitting a freedom to operate (  letter six months before the expiry of the patent. This new version now increases that timeline to 24 months prior to patent expiry. However, the generic product will be registered after the patent has expired.

Innovator companies must include a copy of the patent document for their innovative product, issued by the SAIP, within the registration file submitted to the SFDA. If the patent document is not issued at the time of submitting the registration file, the company is obligated to provide it upon its issuance. For innovative products protected by a patent issued by SAIP or the Gulf Cooperation Council Patent Office and already registered at the SFDA, the company must provide the patent document.

In all cases, if the innovator company claims that the generic product infringes the patent of its product, the company may submit its claims to the Commercial Court. The SFDA must comply with any final and enforceable judgment issued by the competent judicial authorities in favour of the innovator company.

Guideline on Good Pharmacovigilance Practices

(V. 4 – New Version, DS-G-008-V4.0/150527)

This SFDA guidance for the establishment and maintenance of quality assured pharmacovigilance systems for marketing authorisation holders (MAHs) contains extensive modules. This new version contains a variety of additions, updates, and deletions aimed at clarifying g  , including:

1. clarity on the responsibilities of applicants and MAHs;
2. stricter requirements for the qualified person responsible for pharmacovigilance qualifications;
3. a new GVP Annex III – Guide for Marketing Authorization Holders on Joint Direct Healthcare Professional Communications (Joint DHPC) Letter, to address when there are several MAHs of the same active substance for which a DHPC is to be issued (innovator and generics, or different innovators/generics, parallels); and
4. updates to the requirements on the format of educational materials.

Data Requirements for Human Drugs Submission

(V 4 – New Version, DS-REQ-002-V4.0/110622)

This SFDA document update seeks to align with international common technical document (formats. Key points include the following.

1. Effective 1 February 2026, the SFDA will accept well-established use applications. When an active substance has been used for more than 10 years in a , and its efficacy and safety have been well established for the claimed therapeutic indication, the application for marketing authorisation may be based on published scientific literature.
2. A requirement that the application’s cover letter shows the product’s worldwide registration status.
3. A Certificate of Pharmaceutical Product (CPP) / free sale certificate submission is optional and no longer required for any new marketing authorisation applications (MAA). The SFDA reserves the right to request the CPP at any time during the application process or post-authorisation, if deemed necessary.
4. The inclusion of specific drug substance information requirements for viral vectors. Historically, the drug substance information could be submitted in the drug master file, but now the SFDA recognises that products containing viral vectors can submit a viral master file or regulatory support file, as applicable.
5. Updates for biotech where, in addition to the standard information required regarding the structural formula, a schematic representation of the plasmid/vector structure or amino acid sequence should be provided, as appropriate, and should include details such as gene insertion sites, glycosylation sites, other post-translational modifications, and the relative molecular mass.
6. Nitrosamine risk assessment is mandatory, in addition to the standard information on impurities. A risk assessment report should be conducted to determine the materials that contribute to the potential inclusion of nitrosamines in the drug product. All potential sources for the introduction of nitrosamines should be considered in the risk assessment, such as the drug substance, excipients, water (including a discussion of the nitrosamine impurities that may be present in water during the purification and disinfection process), solvents, the manufacturing process, packaging components (e.g. aluminium foil and elastomers), and formation on stability.
   Further, a comprehensive risk assessment to address possible formation of N-nitrosamine impurities in substances for human use is required. If a risk is identified, a suitable control strategy should be introduced. The risk evaluation should not only address risks related to the manufacturing process, but also those deriving from the introduction of materials used in the manufacturing process and other potential sources of contamination (e.g. starting materials, reagents, solvents, recovery of materials, equipment, and degradation).
7. The SFDA highlights that it is essential that the applicant provides detailed documentation of the formula and the method of calculation used to calculate the content of the drug substance or impurities, with numerical values using actual raw data to demonstrate how the final results were obtained. All mathematical transformations, along with a scientific justification for any correction factors used, must be presented.
8. A restriction on the use of thiomersal, which is not permitted in paediatric vaccines intended for children under one year of age.
9. For scored tables, a score line description in the product’s information (e.g. a summary of product characteristics, labelling, or package leaflet) is required, and testing on one batch per strength (i.e. results demonstrating that the proposed tablet breaks evenly) is mandated.
10. Updated rules for advanced therapies.
    • For biosimilars: A comparative quality exercise between the reference product and the proposed biosimilar should be submitted in accordance with the SFDA’s Guideline on Quality Considerations for Development and Comparability Assessment of Biosimilars (Version 2.0, or as updated from time to time).
    • For advanced therapy medicinal products: Providing shipping validation studies, as applicable.

Guideline on Quality Considerations for Development and Comparability Assessment of Biosimilars

(V. 2 – New Version, DS-G-042-V02/170822)

This new version of the SFDA guidance includes comprehensive updates and additions to the previous version, which was issued in 2017. It provides enhanced information for MAA applicants of biosimilars to highlight regulatory considerations for the development of biosimilars and the comparative quality exercise (CQE) required to establish the biosimilarity against the reference product (RP).

The guideline applies to biopharmaceutical products that can be well defined and analytically characterised, such as polypeptides and proteins produced by biotechnology-based approaches. Parts of the principle may be applied to polysaccharides that are produced via a biotechnology process, which are considered on a case-by-case basis. Vaccines and human plasma-derived products, along with animal tissue-derived products, are excluded from the scope of this guideline. Key points include the following.

1. Complete standalone quality/CMC data (eCTD Quality Overall Summary of Module 2 and Module 3) should be provided in the submitted MAA dossier, in addition to the data generated in the CQE comparing the biosimilar to the RP.
2. Updates to the definition of the RP and emphasis that the MAA of a specific b should provide a single original RP from one MAH, including considerations for non-locally registered RPs.
3. For the RP with multiple indications, the SFDA may extrapolate the approval to indications other than those investigated in comparative clinical trials to the BS under the conditions outlined.
4. Enhancement of the CQE framework to a “stepwise and tailored” approach.
   • “Stepwise” refers to the development of the BS that starts with extensive characterisation of the RP to develop a quality target product profile that guides the design of BS manufacturing processes, which is followed by comparability exercises.
   • “Tailored” refers to the extent of three-tiered comparability exercises required to support BS approval. The first-tier comparability exercise comprises the CQE to establish and demonstrate molecular biosimilarity; the second tier comprises the comparative (head-to-head) p; and the third tier is the comparative clinical data needed to confirm high similarity of the safety and efficacy of the BS compared to the RP.
5. Clarity provided on analytical test methods for biosimilars, and statistical approaches for establishing acceptance criteria in CQE.

Regulatory Guidance for Literature Based Support of Efficacy and Safety of Medicines

(V. 1 – New Document, DS-G-127-V01/250411)

This new SFDA guidance document seeks to standardise literature-based submissions when applicant-sponsored trials are unavailable. This guidance assists applicants on the required clinical data for generic (multi-source) products and known active substances (KAS), when the reference innovator is not registered by the SFDA.

The SFDA evaluation process for MAAs relies on the quality of the submitted clinical data. To obtain marketing authorisation for new medicines, it is required to demonstrate a favourable benefit/risk profile through clinical studies. Typically, these studies are sponsored by the applicant. In cases where applicant-sponsored trials are unavailable, the SFDA may accept literature references to these trials in respect of MAAs concerning:

1. new generic applications when the RP is not registered by the SFDA; and
2. new drug applications for KAS.

If literature evidence alone is not substantial, a meta analysis of clinical data is required, except in the case of orphan drugs, which may be exempted. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) Working Group will be used to grade the quality of evidence. Other tools for data analysis of extracted data may be used, such as the Cochrane Handbook for Systematic Reviews of Interventions, to assist in the process of conducting systematic reviews, including data extraction, analysis, and reporting.

Guidelines for Variation Requirements

(V. 6.3 – New Version, DS-G-006-V6.3/110821)

These SFDA guidelines classify variations and provide the basic data required for each type of variation. These guidelines are adopted from the European Medicines Agency   on the details of the various categories of variations. This document applies to changes made to drug products that have already received a marketing authorisation by the SFDA. The variations or post-marketing changes are required to be submitted through the Saudi Drug Registration S  and are classified into two categories: minor variations and major variations.

The new version adds guidelines for new variations, including the following.

1. Change in legal status of a medicinal product or distribution site:
   • for generic/biosimilar medicinal products following an approved legal status or distribution site changes of the reference medicinal product;
   • legal status changes of reference medicinal products that require further substantiation by new additional data to be submitted by the MAH; and
     change to the distribution site of the reference medicinal product.
2. Change in test procedure for the finished product to reflect compliance with the official pharmacopeia and to remove reference to the outdated internal test method and test method number.
3. Extension of the retest period based on extrapolation of stability data not in accordance with guidelines issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, and the (retest period not applicable for biological/immunological active substance).
4. Changes in generic/biosimilar product indication while the reference product is not registered at the

Reference to these updated guidelines is imperative, as for two variations there are updated conditions to be fulfilled, and for another six variations there is updated documentation to be supplied.

Regulations and Requirements for Conducting Clinical Trials on Drugs

(V. 3, – New Version, DS-G-014-V3.0/150708)

Following the last update in November 2021, this new   of the SFDA regulations and requirements for conducting clinical drug trials establishes the following.

1. For early phases trials (phase I, II, III), the applicant must submit a progress report after half the study duration has passed (rather than the previously required every three months) if the trial duration is less than one year.
2. The SFDA has clarified that immediate reporting is required of any suspected unexpected serious adverse reactions (SUSAR), in both local cases and global cases with ongoing trials in Saudi Arabia. Reports should be made no later than 15 days, or 7 days in the case of fatal or life-threatening SUSAR.
3. The SFDA has amended the framework for clinical trials in special cases, such as trials on drugs related to national initiatives from the SFDA and related bodies, and provides such applications with priority appointments via the electronic system for clinical trials.
4. CDs are no longer required, now that the electronic submission of trial documents will be conducted via the SFDA’s cloud service.
5. The SFDA has updated clinical trial requirements to include:
   providing in an Arabic-headed letter the list of submitted documents and the needed scientific advice;
   • a statistical analysis plan, or reference to the plan;
   • a Certificate of Analysis for the Study Drug and Placebo;
   • a valid g from the country of origin;
   • a letter to state the availability of the delegation log;
   • completion of Form No.5, a new form required for all clinical trials; and
   • providing pre-clinical documents as full study reports.