§ 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	🇪🇺European Union
Authority & dossier
Regulatory authority	TGA	EMA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	Available
Reference agencies	FDA, EMA, MHRA, Health Canada +2	—
Lead pathway (timeline & fees) — Standard Prescription Medicine Registration · Centralised Procedure
Pathway name	Standard Prescription Medicine Registration	Centralised Procedure
Approval timeline	220–255 days	210–277 days
Application fee	AUD 273,700	EUR 358,800
Annual renewal	AUD 4,490	EUR 122,500
Local representative	Required	Required
Local manufacturing	Not required	Not required
GMP inspection	Required	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 Responsible for Pharmacovigilance (QPPV) — must reside and operate in the EU/EEA — is responsible for the establishment and maintenance of the pharmacovigilance system. A Qualified Person (QP) in the EU/EEA performs batch certification under Article 51 of Directive 2001/83/EC. Local Contact Person for pharmacovigilance required in each Member State where the product is marketed (since 2012 GVP).
Accelerated pathways
Designations available	3 designations	6 designations
Examples	Priority Review Designation, Provisional Approval, Orphan Drug Designation	Accelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3
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.	Commission Regulation (EC) 1234/2008 establishes four categories: Type IA (minor — Do and Tell, 12-month notification), Type IAIN (minor — immediate notification), Type IB (minor — Tell, Wait, and Do, 30-day default), Type II (major — prior approval, 60–90 days), and Extensions (Annex I changes — full review). Worksharing procedures consolidate 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 — application 9 months before expiry. After the first renewal, MA is granted for unlimited duration unless the CHMP/NCA, on justified grounds relating to pharmacovigilance, decides on one additional 5-year renewal.
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.	Comprehensive PV framework under Directive 2010/84/EU and Regulation (EU) 1235/2010, codified in Good Pharmacovigilance Practices (GVP). Pharmacovigilance System Master File (PSMF) required. Periodic Safety Update Reports (PSURs) on EU-harmonised birth-date list. Risk Management Plans for all new MAs and significant variations. Suspected serious ADR reporting to EudraVigilance within 15 days. Black triangle (▼) for additional monitoring of selected products.
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	60–106 days
GCP standard	ICH-GCP E6(R3) (adopted 2026)	ICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025
Pricing & reimbursement
Price regulation	Regulated	Regulated
Reference pricing	Yes	Yes
HTA required	Yes	Yes
HTA body	Pharmaceutical Benefits Advisory Committee (PBAC)	EU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)

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

Authority & dossier

Regulatory authority

AustraliaTGA
European UnionEMA

English submissions

AustraliaYes
European UnionYes

CTD accepted

AustraliaYes
European UnionYes

eCTD accepted

AustraliaYes
European UnionYes

Reliance pathway

AustraliaAvailable
European UnionAvailable

Reference agencies

AustraliaFDA, EMA, MHRA, Health Canada +2
European Union—

Lead pathway (timeline & fees) — Standard Prescription Medicine Registration · Centralised Procedure

Pathway name

AustraliaStandard Prescription Medicine Registration
European UnionCentralised Procedure

Approval timeline

Australia220–255 days
European Union210–277 days

Application fee

AustraliaAUD 273,700
European UnionEUR 358,800

Annual renewal

AustraliaAUD 4,490
European UnionEUR 122,500

Local representative

AustraliaRequired
European UnionRequired

Local manufacturing

AustraliaNot required
European UnionNot required

GMP inspection

AustraliaRequired
European UnionRequired

MAH & local presence

Local entity required

AustraliaYes
European UnionYes

Local responsible person

AustraliaYes
European UnionYes

RP role

AustraliaAuthorised Person for Pharmacovigilance: Australian-resident contact responsible for pharmacovigilance, periodic safety reporting, and TGA correspondence.
European UnionQualified Person Responsible for Pharmacovigilance (QPPV) — must reside and operate in the EU/EEA — is responsible for the establishment and maintenance of the pharmacovigilance system. A Qualified Person (QP) in the EU/EEA performs batch certification under Article 51 of Directive 2001/83/EC. Local Contact Person for pharmacovigilance required in each Member State where the product is marketed (since 2012 GVP).

Accelerated pathways

Designations available

Australia3 designations
European Union6 designations

Examples

AustraliaPriority Review Designation, Provisional Approval, Orphan Drug Designation
European UnionAccelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3

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.
European UnionCommission Regulation (EC) 1234/2008 establishes four categories: Type IA (minor — Do and Tell, 12-month notification), Type IAIN (minor — immediate notification), Type IB (minor — Tell, Wait, and Do, 30-day default), Type II (major — prior approval, 60–90 days), and Extensions (Annex I changes — full review). Worksharing procedures consolidate 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.
European UnionInitial 5-year renewal — application 9 months before expiry. After the first renewal, MA is granted for unlimited duration unless the CHMP/NCA, on justified grounds relating to pharmacovigilance, decides on one additional 5-year renewal.

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.
European UnionComprehensive PV framework under Directive 2010/84/EU and Regulation (EU) 1235/2010, codified in Good Pharmacovigilance Practices (GVP). Pharmacovigilance System Master File (PSMF) required. Periodic Safety Update Reports (PSURs) on EU-harmonised birth-date list. Risk Management Plans for all new MAs and significant variations. Suspected serious ADR reporting to EudraVigilance within 15 days. Black triangle (▼) for additional monitoring of selected products.

Unlicensed access

Named Patient Supply

AustraliaAvailable
European UnionAvailable

Compassionate Use

AustraliaAvailable
European UnionAvailable

Emergency Import

AustraliaAvailable
European UnionAvailable

Parallel Import

AustraliaNot permitted
European UnionPermitted

Clinical trials

CTA approval

AustraliaNotification
European UnionRequired

Ethics approval

AustraliaYes
European UnionYes

CTA timeline

Australia14–60 days
European Union60–106 days

GCP standard

AustraliaICH-GCP E6(R3) (adopted 2026)
European UnionICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025

Pricing & reimbursement

Price regulation

AustraliaRegulated
European UnionRegulated

Reference pricing

AustraliaYes
European UnionYes

HTA required

AustraliaYes
European UnionYes

HTA body

AustraliaPharmaceutical Benefits Advisory Committee (PBAC)
European UnionEU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)