The Saudi Food & Drug Authority (SFDA) has established clear requirements for Investigational New Drug (IND) applications to ensure patient safety, scientific integrity, and regulatory compliance when conducting clinical trials in the Kingdom of Saudi Arabia. Below is a comprehensive overview of the key requirements, responsibilities, and processes sponsors and investigators must follow.

Purpose of IND Requirements

• Protect the rights, safety, and well-being of trial participants.
• Ensure that clinical trials are conducted with sound scientific and ethical principles.
• Support the development of safe and effective drugs for the Saudi market.

Types of IND

• Investigator IND: Submitted by a physician who both initiates and conducts the study.
• Emergency IND: Grants rapid SFDA authorization for use in urgent cases without prior full IND submission.
• Treatment IND: Allows use of a promising investigational drug for patients with serious or life-threatening conditions while final studies are ongoing.

Pre-IND Meeting

Sponsors may request a pre-IND meeting (at least 30 days in advance) to discuss:

• Chemistry, Manufacturing, and Controls (CMC) data.
• Safety information.
• Clinical study design and development plan.

IND Application Requirements

1. Cover Sheet: Sponsor details, study phase, and regulatory commitments.
2. Table of Contents: With page numbers for easy navigation.
3. Introductory Statement & General Plan: Drug description, formula, indications, estimated patient numbers, and risk assessment.
4. Investigator’s Brochure: Comprehensive data on pharmacology, toxicology, PK/PD, prior human experience, and precautions.
5. Study Protocols: Detailed plans for Phase 1–3 studies, including objectives, patient selection, controls, endpoints, monitoring procedures, investigator qualifications, and IRB details.
6. CMC Information: Drug substance and product details, manufacturing process, stability data, labeling, and placebo description.
7. Pharmacology & Toxicology Data: Summaries of animal/in vitro studies, GLP compliance statement, and tabulated data.
8. Previous Human Experience: Clinical data, marketing history, withdrawals, and relevant published literature.

Phases of Clinical Investigation

• Phase 1: Focuses on safety, dosage tolerance, and pharmacokinetics in 20–80 healthy volunteers.
• Phase 2: Evaluates efficacy, optimal dosing, and short-term safety in several hundred patients.
• Phase 3: Confirms efficacy, monitors adverse reactions, and collects data for product labeling using large patient populations.

Post-Submission & Reporting

• Protocol Amendments: Must be approved by SFDA and IRB before implementation (except for emergency safety measures).
• IND Safety Reports: Sponsors must promptly report serious and unexpected adverse events (7 days for fatal/life-threatening, 15 days for others).
• Annual Reports: Provide study status, patient exposure, adverse events summary, manufacturing changes, and future plans.

Exemptions

• The drug is lawfully marketed in Saudi Arabia.
• The study does not seek a new indication, labeling change, or pose new risks.
• The trial is IRB-approved, follows informed consent rules, and complies with advertising restrictions.

SFDA Oversight

• Clinical Hold: SFDA may suspend or delay a trial if subject safety is at risk, protocols are deficient, or investigators are unqualified.
• Inactive Status: Applied if no subjects are enrolled for two years or a study remains on hold for one year.
• Termination: May occur for safety concerns, false submissions, or noncompliance.

Responsibilities

Sponsor

• Select qualified investigators and monitors.
• Provide investigators with updated safety and protocol information.
• Monitor studies and halt unsafe trials if necessary.
• Maintain detailed records (shipments, financials, safety data) for at least two years.
• Ensure proper drug storage, return, or destruction.
• Transfer obligations to CROs only through documented agreements with SFDA approval.

Investigator

• Maintain strict control over the investigational drug.
• Ensure IRB approval and inform IRB of any changes or risks.
• Keep accurate records (drug disposition, case histories, informed consent).
• Report progress, safety issues, and final results to the sponsor.
• Allow SFDA inspections and comply with controlled substance regulations.

Submission Guidelines

• Include translations for any non-English documents with originals.
• Submit 2 hardcopies and 1 electronic copy of the IND.
• Number submissions sequentially (three-digit serial numbers starting at 000).