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