Preclinical data refer to laboratory and animal testing of a drug’s safety, biological activity, and efficacy before it is studied in humans. This data becomes the scientific basis for new drug applications submitted to the SFDA. When you apply for Clinical Trial Authorization (CTA) or Drug Marketing Authorization (MA) in Saudi Arabia, you must submit clear, consistent, and well-organized non-clinical data to the SFDA.
This article discusses the SFDA requirements and how to comply with them during the early development phase of chemical and biological products.
Table of contents
Types of Preclinical Studies Required
These studies provide the scientific basis for initiating the first human trial and help determine the appropriate design, dosage, and safety monitoring.
New Drug Applications
For Clinical Trial Applications (CTA)
| Study Type | Purpose |
|---|---|
| Single-dose toxicity | Evaluates CNS, respiratory, and cardiovascular functions |
| Repeat-dose toxicity | Assesses systemic toxicity over time |
| Pharmacokinetics | Measures ADME parameters |
| Toxicokinetic | Links systemic exposure to toxicity findings |
| Safety pharmacology | Examines irritation/sensitisation at the site |
| Genotoxicity (if needed) | Screens for mutagenicity or DNA damage |
| Local tolerance (if needed) | Examines irritation/sensitization at the site |
For Marketing Authorisation Applications (MAA)
| Study Type | Purpose |
|---|---|
| Primary & secondary pharmacodynamics | Determines mechanism and off-target effects |
| Repeat-dose toxicity | Systemic evaluation under intended use duration |
| Genotoxicity | Mandatory (Ames + chromosomal aberration assays) |
| Carcinogenicity (if applicable) | Long-term tumorigenic risk |
| Reproductive toxicity | Covers fertility, embryo-fetal and developmental |
| Immunotoxicity (if needed) | Immune function impact |
| Local tolerance | Especially for injectables, implants, topicals |
| Additional specialized studies | As per product risks (e.g., phototoxicity) |
New Generic Drug Application
- Requires:
- Justification for different salt/form of API
- Summary of impurities (specifications + rationale)
- Requires a literature-based non-clinical overview (Module 2.4) if the reference product is not registered with SFDA.
Impurities
- Must justify impurity limits based on:
- ICH Q3A/B thresholds
- Pharmacopeial limits (USP, BP, Ph. Eur.)
- Existing safety/toxicological data
- Scientific literature
- Analytical comparison with the reference drug
- Assess the mutagenic potential in accordance with ICH M7.
Residual Solvents and Elemental Impurities
- Must comply with:
- ICH Q3C (residual solvents)
- ICH Q3D (elemental impurities)
- Risk assessment must justify PDE (Permitted Daily Exposure) levels
Documentation and Data Requirements
Each reported study must include the following:
- Raw data sets for all toxicological, PK, and safety studies.
- Detailed protocols: description of animal models, justification for their use, and rationale for the selected dosage.
- Results of statistical analysis and interpretation of reproducible data.
- Provide a QA statement confirming that the studies complied with GxP.
- Non-clinical overview and summary per CTD format.
- Provide a scientific justification for the waiver, if any study was omitted.
Preclinical Study Design Considerations
When designing studies, ensure the following:
- The route of administration in animals reflects the proposed human use.
- Species selection is pharmacologically relevant (especially for biologics).
- Dose levels cover anticipated human exposure and safety margins.
- The study duration aligns with the clinical trial length or intended use.
- Follow gender inclusion and ethical animal use standards.
- SFDA encourages alignment with ICH guidelines (e.g., ICH M3, S6).
About the Author
Published by regulatory affairs team in PharmaKnowl, Riyadh office.
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