Saudi Arabia

Saudi Arabia Clinical Trial Quote Request

Clinical Trials Quote Request

Yes

SFDA Regulations & Requirements for Conducting Clinical Trials on Drugs specifies Subjects Insurance is required for Phase II & III, but not Phase IV studies. There is no mention about Phase 0 or 1 studies, so it is unclear if these studies are permitted in Saudi Arabia or not. Please confirm with your CRO or Ethics Committee.

n/a

n/a

THE PROCESS TO ISSUE DOCUMENTS IS SLOW. PLEASE ALLOW ENOUGH TIME AS WE ARE NOT ABLE TO EXPEDITE DOCUMENTS. It is very SLOW due to the intermediaries involved. Submission should be made to Newfront at least one month before documents are required.

Please note that only a Policy is provided. Certificates are not provided for Saudi Arabia.

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Local CRO/Legal Representative details (Contact Person Name, Address, Telephone Number and E-Mail Address)

The Local CRO/Legal Representative must provide the following documents:
• Letter of Appointment issued by the Local CRO/Legal Representative in Saudi Arabia addressed to Saudi broker
• Commercial Registration (CR) with the Saudi Chamber of Commerce
• National Address Registration (NAR) by logging into https://address.gov.sa/sa/ar/
to register the national address in Saudi Arabia
• VAT Certificate
• Complete a "Know Your Client (KYC)" application form - to be provided separately by Newfront
• Copy of Passport/ID of Local CRO/Legal Representative

China Clinical Trial Quote Request

Yes

Unknown

3 months

THE PROCESS TO ISSUE DOCUMENTS IS SLOW. China is a cash for cover country, meaning payment must be made PRIOR to the release of documentation. Please allow 2-3 weeks for documentation to be issued

• Clinical Trial Quote Request Form
• Protocol and Informed Consent in English
• Protocol Title in Chinese
• Legal Representative or Local CRO contact information (Contact Person Name, Address, Telephone Number and E-Mail Address). The Legal Representative is named on the Policy. The Sponsor is the Additional Insured
• Provide the Business License of Sponsor
• Provide the Business License pf Chinese CRO
• Provide the ID Copy of representative of Chinese CRO
• Premium payments are paid directly by the Sponsor to the carrier. No refund for policy cancellation
• Only Policies are typically issued in China. If the EC requests a Certificate to be issued, the Insurer will provide