Advanced Therapy Medicinal Products (ATMPs) Regulations in Saudi Arabia: A Strategic Overview

The Saudi Food and Drug Authority (SFDA) has comprehensive regulations to transform how Advanced Therapy Medicinal Products (ATMPs), such as gene therapies, cell-based innovations, and cutting-edge combination products, are classified and approved in the Kingdom.

If you’re in biotech, pharma, or healthcare, here’s what you need to know and why these matters for the future of patient care and innovation in Saudi Arabia.

Introduction to ATMPs

ATMPs include gene therapies, cell-based treatments (e.g CAR-T cells), and tissue-engineered products designed to treat, prevent, or even cure complex diseases. They represent a significant leap toward personalised and regenerative healthcare.

Classification of ATMPs

The SFDA categorises ATMPs into three primary types:

Gene Therapy Medicinal Products (GTMPs)

• Medicines that use recombinant nucleic acids (DNA or RNA) to treat or prevent diseases at the genetic level.
• The therapeutic effect must come directly from the genetic sequence or its expression. Vaccines against infectious diseases are excluded.

Cell-Based Medicinal Products (CBMPs)

These involve cells or tissues that are substantially manipulated or used for a different essential function in the recipient than in the donor. CBMPs include:

• Somatic Cell Therapy Medicinal Products (sCTMPs): Biological medicines containing cells or tissues that have been substantially manipulated or used for a different essential function, and are intended to treat, prevent, or diagnose diseases through pharmacological, immunological, or metabolic actions.
• Tissue Engineered Products (TEPs): contain engineered cells or tissues, designed to regenerate, repair, or replace human tissue, and may include additional substances like biomaterials or scaffolds. Products made only from non-viable(dead) cells or tissues, which do not work mainly through biological action, are not considered TEPs.

Combined ATMPs

Combined advanced therapy medicinal products (ATMPs) are treatments that merge a medical device with cells or tissues, where the biological component plays the central therapeutic role.

Decision Tree for Classifying (ATMPs)

The SFDA classifies ATMPs based on whether a product contains engineered, viable cells or recombinant nucleic acids that directly drive its therapeutic effect. Substantial manipulation or using cells for a different function qualifies a product as an ATMP. In contrast, animal cell products are always included, and non-viable cells without biological action are excluded.

Substantial vs. Non-Substantial Manipulation: What’s the Impact?

• Substantial manipulation means changing the core characteristics or function of cells/tissues (gene editing, cell expansion).
• Non-substantial manipulation covers basic processes like cutting, grinding, fragmentation, shaping, freezing, or washing, if the essential properties stay the same.
• This distinction is crucial: it determines whether your product is an ATMP or a standard medicinal product/transplant.

Engaging with SFDA

Developers can seek classification advice at any stage of product development, even before clinical data is available. The SFDA classification helps clarify the regulatory framework and requirements for clinical trial applications and further product development.

Registration

• Pre-Submission Consultation: Optional but advisable to clarify requirements.
• Submission: The application requirements are similar to typical drug application requirements.
• Labelling: read the drug labelling requirements.
• Clinical Trials: Read the SFDA Clinical Trials Requirements in Saudi Arabia
• Post-Market Surveillance: read the Saudi Pharmacovigilance System.
• Manufacturers: GMP approval is required.
• Stability Testing: refer to the SFDA Stability Study Standards.

How PharmaKnowl Supports ATMP Registration

Our biotech experts will support your strategy development for the SFDA approval for your gene and cell therapy, including primary gap analysis on the quality and clinical requirements up to preparation for the pre-submission meeting with the SFDA, and access arrangements with top healthcare facilities in Saudi Arabia.

• Regulatory Strategy Development
• Dossier Preparation and Submission
• GMP Inspection Readiness
• Labelling and Packaging Compliance
• Post-Market Surveillance Planning
• Access agreements with healthcare providers

PharmaKnowl can significantly accelerate your access by executing your SFDA approval project in parallel with your search for local commercial partners. Contact us for an exploratory meeting.