§ 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	🇦🇺Australia	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	TGA	MHRA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	Available
Reference agencies	FDA, EMA, MHRA, Health Canada +2	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — Standard Prescription Medicine Registration · International Recognition Procedure (IRP)
Pathway name	Standard Prescription Medicine Registration	International Recognition Procedure (IRP)
Approval timeline	220–255 days	60–110 days
Application fee	AUD 273,700	GBP 35,305
Annual renewal	AUD 4,490	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	Authorised Person for Pharmacovigilance: Australian-resident contact responsible for pharmacovigilance, periodic safety reporting, and TGA correspondence.	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	3 designations	4 designations
Examples	Priority Review Designation, Provisional Approval, Orphan Drug Designation	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	Variations to ARTG entries follow a Type-classified system (Self-Assessable Notifications, Minor Variations, Notifications, and Major Variations) broadly aligned with EU classification.	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	ARTG entries do not formally expire but require payment of the annual entry fee (AUD 4,490 per registration). Failure to pay results in cancellation. No fixed renewal cycle.	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	Sponsors must maintain a Pharmacovigilance System Master File equivalent and report ADRs to TGA. PBRERs follow ICH E2C(R2). Black Triangle scheme applies to selected new medicines requiring intensive monitoring.	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	Notification	Required
Ethics approval	Yes	Yes
CTA timeline	14–60 days	30–60 days
GCP standard	ICH-GCP E6(R3) (adopted 2026)	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	Pharmaceutical Benefits Advisory Committee (PBAC)	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

AustraliaTGA
United KingdomMHRA

English submissions

AustraliaYes
United KingdomYes

CTD accepted

AustraliaYes
United KingdomYes

eCTD accepted

AustraliaYes
United KingdomYes

Reliance pathway

AustraliaAvailable
United KingdomAvailable

Reference agencies

AustraliaFDA, EMA, MHRA, Health Canada +2
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — Standard Prescription Medicine Registration · International Recognition Procedure (IRP)

Pathway name

AustraliaStandard Prescription Medicine Registration
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Australia220–255 days
United Kingdom60–110 days

Application fee

AustraliaAUD 273,700
United KingdomGBP 35,305

Annual renewal

AustraliaAUD 4,490
United KingdomGBP 0

Local representative

AustraliaRequired
United KingdomNot required

Local manufacturing

AustraliaNot required
United KingdomNot required

GMP inspection

AustraliaRequired
United KingdomNot required

MAH & local presence

Local entity required

AustraliaYes
United KingdomYes

Local responsible person

AustraliaYes
United KingdomYes

RP role

AustraliaAuthorised Person for Pharmacovigilance: Australian-resident contact responsible for pharmacovigilance, periodic safety reporting, and TGA correspondence.
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

Australia3 designations
United Kingdom4 designations

Examples

AustraliaPriority Review Designation, Provisional Approval, Orphan Drug Designation
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

Post-approval lifecycle

Variations framework

AustraliaVariations to ARTG entries follow a Type-classified system (Self-Assessable Notifications, Minor Variations, Notifications, and Major Variations) broadly aligned with EU classification.
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

AustraliaARTG entries do not formally expire but require payment of the annual entry fee (AUD 4,490 per registration). Failure to pay results in cancellation. No fixed renewal cycle.
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

AustraliaSponsors must maintain a Pharmacovigilance System Master File equivalent and report ADRs to TGA. PBRERs follow ICH E2C(R2). Black Triangle scheme applies to selected new medicines requiring intensive monitoring.
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

AustraliaAvailable
United KingdomAvailable

Compassionate Use

AustraliaAvailable
United KingdomAvailable

Emergency Import

AustraliaAvailable
United KingdomAvailable

Parallel Import

AustraliaNot permitted
United KingdomPermitted

Clinical trials

CTA approval

AustraliaNotification
United KingdomRequired

Ethics approval

AustraliaYes
United KingdomYes

CTA timeline

Australia14–60 days
United Kingdom30–60 days

GCP standard

AustraliaICH-GCP E6(R3) (adopted 2026)
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

AustraliaRegulated
United KingdomRegulated

Reference pricing

AustraliaYes
United KingdomNo

HTA required

AustraliaYes
United KingdomYes

HTA body

AustraliaPharmaceutical Benefits Advisory Committee (PBAC)
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)