Regulations and Requirements for Conducting Clinical Trials on Drugs (Version 4.0)

Key changes

Key changes include: 1) Revision of all definitions to align with global standards; 2) Addition of terms like Biosimilar, Stringent Regulatory Authority (SRA), and Post-Trial Access Program (PTAP); 3) Updated guidance on submissions, waves, and timelines for clinical trial phases; 4) Implementation of a new section on reliance pathways; 5) New requirements for PI-initiated trials; 6) Introduction of the Post-Clinical Trial Access Program with associated forms for clearance requests.

PV impact

The updated regulation has direct pharmacovigilance impact: 1) It mandates that observational Phase IV trials and registry studies adhere to Good Pharmacovigilance Practices (GVP) guidelines; 2) It requires consultation with the Drug Safety and Risk Management Department for risk minimization studies (RIMS); 3) It provides updated definitions for adverse reactions and Suspected Unexpected Serious Adverse Reactions (SUSARs) in the context of clinical trials; 4) It establishes requirements for Post-Trial Access Programs which may involve ongoing safety monitoring.

Exact policy details

Date of Issue

08 July 2015

Applies to: All clinical trials conducted in Saudi Arabia.

According to the Saudi Food and Drug Authority law issued on 25/1/1428 H. · p. 10 · High · Source

Date of Implementation

08 July 2015

Applies to: All clinical trials conducted in Saudi Arabia.

Date of implementation mentioned in the regulations. · p. 1 · High · Source

Financial Fees for Clinical Trial Evaluation

15,000 Saudi Riyals

Applies to: Applicable to private sector sponsored clinical trials, unless exempt.

Applicant must pay financial fees as per memo number (9699) issued on 23/4/1432H. · p. 10 · High · Source

Notification Period for Phase IV Trials

20 working days

Applies to: Applicants must notify SFDA after obtaining local IRB approval.

After obtaining local IRB approval, the applicant must notify SFDA within 20 working days. · p. 10 · High · Source

SUSAR Reporting Timeframe

15 days

Applies to: For suspected unexpected serious adverse reactions.

Mandatory to report SUSARs no later than 15 days as per clinical trials safety reporting. · p. 12 · High · Source

Annual Report Submission Timeline

1 year or half the study duration

Applies to: For ongoing trials, depending on trial length.

Annual progress report must be submitted after obtaining approval within one year. · p. 11 · High · Source

Workflow rule impacts

Extracted documents

• Regulations and Requirements for Conducting Clinical Trials on Drugs (Version 4.0)pdfpdf_text · high · 41 pages