MEA Region Countries Regulation in place CT Guide Healthy subjects File Submission Competent Authorities§ Procedure Site IP Importation Study Report Fees SAE Reporting Document archival Approval Timelines Insurance for CT IP temporary use Biological samples export
Algeria YES* YES YES Paper Local Sequential Public CCA annual NO ICH regulation 15 years 90 working days YES Information Not Available Information Not Available
Burkina Faso YES† NO YES Paper Central Information Not Available Both Information Not Available annual YES ICH regulation Information Not Available 90 working days YES Information Not Available YES
Cameroun Information Not Available NO Information Not Available Paper Information Not Available Information Not Available Public Information Not Available Information Not Available Information Not Available ICH regulation Information Not Available Information Not Available Information Not Available Information Not Available YES
Ivory Coast Information Not Available NO Information Not Available Paper Central Sequential Information Not Available Information Not Available Information Not Available YES ICH regulation ICH regulation 90 working days YES YES Information Not Available
Egypt YES† YES YES Electronic + Paper Local Sequential Public IL Bi-annual YES ICH regulation ICH regulation 90 working days YES YES YES
Iran YES* NO YES Electronic + Paper Central Sequential Information Not Available Information Not Available Bi-annual NO ICH regulation ICH regulation Information Not Available Information Not Available Information Not Available Information Not Available
Jordan YES‡ YES YES Electronic + Paper Local Sequential Both IL annual YES ICH regulation ICH regulation 90 working days YES Information Not Available YES
Kenya YES* NO YES Electronic + Paper Central Parallel Both CCA annual NO ICH regulation ICH regulation 90 working days YES Information Not Available Information Not Available
Lebanon YES* NO YES PS Local Sequential Both IL annual NO ICH regulation ICH regulation 90 working days YES Information Not Available YES
Morrocco YES* YES YES PS Central Sequential Both IL Bi-annual NO ICH regulation 20 years More than 90 working days YES Information Not Available YES
Nigeria Information Not Available NO Information Not Available PS Local Parallel Public CCA annual YES ICH regulation ICH regulation 90 working days YES Information Not Available YES
Pakistan YES‡ NO YES Electronic + Paper Central Sequential Both IL annual NO ICH regulation Information Not Available More than 90 working days YES Information Not Available Information Not Available
Congo YES* NO YES Paper N/A Information Not Available Information Not Available Information Not Available Information Not Available Information Not Available ICH regulation Information Not Available Information Not Available Information Not Available Information Not Available Information Not Available
Saudi Arabia YES‡ YES YES Electronic Central Parallel Both ICH annual YES ICH regulation ICH regulation 90 working days YES NO YES
South Africa YES‡ YES YES Electronic + Paper Local Parallel Both CCA annual YES ICH regulation 15 years More than 90 working days YES Information Not Available YES
Tunisia YES† NO YES Electronic + Paper Central Parallel Both CCA annual NO ICH regulation ICH regulation 90 working days YES Information Not Available YES