§ 02 — Comparison

Compare regulatory pathways side-by-side

Benchmark MAHMAH, GMPGMP, HTAHTA and pathway requirements across up to three markets.

Country A

Country B

Country C

Highlight differences

Criterion	🇸🇦Saudi Arabia	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	SFDA	MHRA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	Available
Reference agencies	FDA, EMA (centralised), MHRA, Health Canada +3	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — Standard Marketing Authorisation (Full Review) · International Recognition Procedure (IRP)
Pathway name	Standard Marketing Authorisation (Full Review)	International Recognition Procedure (IRP)
Approval timeline	240–365 days	60–110 days
Application fee	SAR 75,000	GBP 35,305
Annual renewal	SAR 15,000	GBP 0
Local representative	Required	Not required
Local manufacturing	Not required	Not required
GMP inspection	Required	Not required
MAH & local presence
Local entity required	Yes	Yes
Local responsible person	Yes	Yes
RP role	A Saudi-resident Pharmacist must be designated as Responsible Person; a Pharmacovigilance Officer is required and must report to the Saudi Pharmacovigilance Centre. Saudisation (Nitaqat) requirements apply to local agent staff.	Qualified Person (Pharmacovigilance) — QPPV — must reside in the UK or EEA. UK Responsible Person (Import) for batch certification of products imported into GB. Local pharmacovigilance contact in the UK required for risk minimisation activities.
Accelerated pathways
Designations available	4 designations	4 designations
Examples	Priority Review, Orphan Drug Pathway, Conditional Approval +1	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	Variations classified into Major, Minor, and Notification, broadly aligned with EU Type IA/IB/II framework. SFDA also accepts variation worksharing for products approved via the Verification Pathway when the SRA has approved the same change.	Variations classified per UK Variations Regulations (mirroring EU Reg 1234/2008): Type IA, IAIN, IB, II, and Extensions. MHRA Worksharing available for grouped variations across multiple authorisations.
Renewal cycle	Marketing authorisations valid for 5 years; renewal required 6 months before expiry. Renewal includes updated PSUR, sales data, and pharmacovigilance summary.	Initial 5-year renewal; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.
Pharmacovigilance	Saudi Pharmacovigilance Centre (under SFDA). PSURs aligned with ICH E2C(R2). Mandatory ICSR reporting via the National Pharmacovigilance Centre online portal. KSA is a WHO-UMC member.	MHRA operates the Yellow Card Scheme for ADR reporting. PSURs follow the EU Reference Date list pre-Brexit, with MHRA UK-specific PSUR list since 2021. RMPs required for new MAs and significant variations. Black triangle (▼) for additional monitoring.
Unlicensed access
Named Patient Supply	Available	Available
Compassionate Use	Available	Available
Emergency Import	Available	Available
Parallel Import	Not permitted	Permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	60–90 days	30–60 days
GCP standard	ICH-GCP	ICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)
Pricing & reimbursement
Price regulation	Regulated	Regulated
Reference pricing	Yes	No
HTA required	Yes	Yes
HTA body	SFDA Health Technology Assessment (HTA) Unit + Saudi Health Council HTA committee	NICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)

Verdict colours indicate lower, moderate, or higher regulatory burden — they're not value judgements on a market.

Authority & dossier

Regulatory authority

Saudi ArabiaSFDA
United KingdomMHRA

English submissions

Saudi ArabiaYes
United KingdomYes

CTD accepted

Saudi ArabiaYes
United KingdomYes

eCTD accepted

Saudi ArabiaYes
United KingdomYes

Reliance pathway

Saudi ArabiaAvailable
United KingdomAvailable

Reference agencies

Saudi ArabiaFDA, EMA (centralised), MHRA, Health Canada +3
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — Standard Marketing Authorisation (Full Review) · International Recognition Procedure (IRP)

Pathway name

Saudi ArabiaStandard Marketing Authorisation (Full Review)
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Saudi Arabia240–365 days
United Kingdom60–110 days

Application fee

Saudi ArabiaSAR 75,000
United KingdomGBP 35,305

Annual renewal

Saudi ArabiaSAR 15,000
United KingdomGBP 0

Local representative

Saudi ArabiaRequired
United KingdomNot required

Local manufacturing

Saudi ArabiaNot required
United KingdomNot required

GMP inspection

Saudi ArabiaRequired
United KingdomNot required

MAH & local presence

Local entity required

Saudi ArabiaYes
United KingdomYes

Local responsible person

Saudi ArabiaYes
United KingdomYes

RP role

Saudi ArabiaA Saudi-resident Pharmacist must be designated as Responsible Person; a Pharmacovigilance Officer is required and must report to the Saudi Pharmacovigilance Centre. Saudisation (Nitaqat) requirements apply to local agent staff.
United KingdomQualified Person (Pharmacovigilance) — QPPV — must reside in the UK or EEA. UK Responsible Person (Import) for batch certification of products imported into GB. Local pharmacovigilance contact in the UK required for risk minimisation activities.

Accelerated pathways

Designations available

Saudi Arabia4 designations
United Kingdom4 designations

Examples

Saudi ArabiaPriority Review, Orphan Drug Pathway, Conditional Approval +1
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

Post-approval lifecycle

Variations framework

Saudi ArabiaVariations classified into Major, Minor, and Notification, broadly aligned with EU Type IA/IB/II framework. SFDA also accepts variation worksharing for products approved via the Verification Pathway when the SRA has approved the same change.
United KingdomVariations classified per UK Variations Regulations (mirroring EU Reg 1234/2008): Type IA, IAIN, IB, II, and Extensions. MHRA Worksharing available for grouped variations across multiple authorisations.

Renewal cycle

Saudi ArabiaMarketing authorisations valid for 5 years; renewal required 6 months before expiry. Renewal includes updated PSUR, sales data, and pharmacovigilance summary.
United KingdomInitial 5-year renewal; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.

Pharmacovigilance

Saudi ArabiaSaudi Pharmacovigilance Centre (under SFDA). PSURs aligned with ICH E2C(R2). Mandatory ICSR reporting via the National Pharmacovigilance Centre online portal. KSA is a WHO-UMC member.
United KingdomMHRA operates the Yellow Card Scheme for ADR reporting. PSURs follow the EU Reference Date list pre-Brexit, with MHRA UK-specific PSUR list since 2021. RMPs required for new MAs and significant variations. Black triangle (▼) for additional monitoring.

Unlicensed access

Named Patient Supply

Saudi ArabiaAvailable
United KingdomAvailable

Compassionate Use

Saudi ArabiaAvailable
United KingdomAvailable

Emergency Import

Saudi ArabiaAvailable
United KingdomAvailable

Parallel Import

Saudi ArabiaNot permitted
United KingdomPermitted

Clinical trials

CTA approval

Saudi ArabiaRequired
United KingdomRequired

Ethics approval

Saudi ArabiaYes
United KingdomYes

CTA timeline

Saudi Arabia60–90 days
United Kingdom30–60 days

GCP standard

Saudi ArabiaICH-GCP
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

Saudi ArabiaRegulated
United KingdomRegulated

Reference pricing

Saudi ArabiaYes
United KingdomNo

HTA required

Saudi ArabiaYes
United KingdomYes

HTA body

Saudi ArabiaSFDA Health Technology Assessment (HTA) Unit + Saudi Health Council HTA committee
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)