§ 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	🇿🇦South Africa	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	SAHPRA	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 +2	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — Standard Registration (Full Review) · International Recognition Procedure (IRP)
Pathway name	Standard Registration (Full Review)	International Recognition Procedure (IRP)
Approval timeline	365–1095 days	60–110 days
Application fee	ZAR 38,000	GBP 35,305
Annual renewal	ZAR 16,500	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 SA-resident Responsible Pharmacist registered with the South African Pharmacy Council (SAPC) is mandatory for the Section 22C licence. A separate Pharmacovigilance Officer is required and must report to SAHPRA Pharmacovigilance.	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	Risk-Based Prioritised Review, WHO Collaborative Procedure, Section 21 Authorisation (Pre-Approval Access) +1	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	Post-approval variations classified into Type IA, IB, II, and Notification, broadly aligned with EU framework. SAHPRA variations guideline (2020) implemented after MCC-to-SAHPRA transition.	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/distribution 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	SAHPRA Pharmacovigilance Department coordinates with the National Adverse Drug Event Monitoring Centre (NADEMC) at University of Cape Town. PSURs aligned with ICH E2C(R2). Mandatory ICSR reporting via SAHPRA Med Safety app and online portal. South Africa 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	60–180 days	30–60 days
GCP standard	South African GCP Guidelines + 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	No	Yes
HTA body	National Essential Medicines List Committee (NEMLC); NHI HTA committee under development	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

South AfricaSAHPRA
United KingdomMHRA

English submissions

South AfricaYes
United KingdomYes

CTD accepted

South AfricaYes
United KingdomYes

eCTD accepted

South AfricaYes
United KingdomYes

Reliance pathway

South AfricaAvailable
United KingdomAvailable

Reference agencies

South AfricaFDA, EMA (centralised), MHRA, Health Canada +2
United KingdomFDA, EMA, Health Canada, Swissmedic +4

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

Pathway name

South AfricaStandard Registration (Full Review)
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

South Africa365–1095 days
United Kingdom60–110 days

Application fee

South AfricaZAR 38,000
United KingdomGBP 35,305

Annual renewal

South AfricaZAR 16,500
United KingdomGBP 0

Local representative

South AfricaRequired
United KingdomNot required

Local manufacturing

South AfricaNot required
United KingdomNot required

GMP inspection

South AfricaRequired
United KingdomNot required

MAH & local presence

Local entity required

South AfricaYes
United KingdomYes

Local responsible person

South AfricaYes
United KingdomYes

RP role

South AfricaA SA-resident Responsible Pharmacist registered with the South African Pharmacy Council (SAPC) is mandatory for the Section 22C licence. A separate Pharmacovigilance Officer is required and must report to SAHPRA Pharmacovigilance.
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

South Africa4 designations
United Kingdom4 designations

Examples

South AfricaRisk-Based Prioritised Review, WHO Collaborative Procedure, Section 21 Authorisation (Pre-Approval Access) +1
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

Post-approval lifecycle

Variations framework

South AfricaPost-approval variations classified into Type IA, IB, II, and Notification, broadly aligned with EU framework. SAHPRA variations guideline (2020) implemented after MCC-to-SAHPRA transition.
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

South AfricaMarketing authorisations valid for 5 years; renewal required 6 months before expiry. Renewal includes updated PSUR, sales/distribution 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

South AfricaSAHPRA Pharmacovigilance Department coordinates with the National Adverse Drug Event Monitoring Centre (NADEMC) at University of Cape Town. PSURs aligned with ICH E2C(R2). Mandatory ICSR reporting via SAHPRA Med Safety app and online portal. South Africa 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

South AfricaAvailable
United KingdomAvailable

Compassionate Use

South AfricaAvailable
United KingdomAvailable

Emergency Import

South AfricaAvailable
United KingdomAvailable

Parallel Import

South AfricaNot permitted
United KingdomPermitted

Clinical trials

CTA approval

South AfricaRequired
United KingdomRequired

Ethics approval

South AfricaYes
United KingdomYes

CTA timeline

South Africa60–180 days
United Kingdom30–60 days

GCP standard

South AfricaSouth African GCP Guidelines + ICH-GCP
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

South AfricaRegulated
United KingdomRegulated

Reference pricing

South AfricaYes
United KingdomNo

HTA required

South AfricaNo
United KingdomYes

HTA body

South AfricaNational Essential Medicines List Committee (NEMLC); NHI HTA committee under development
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)