§ 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	🇳🇿New Zealand	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	Medsafe	MHRA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	Available
Reference agencies	FDA, EMA, MHRA, TGA +2	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — New Medicine Application — Full Evaluation (Section 23) · International Recognition Procedure (IRP)
Pathway name	New Medicine Application — Full Evaluation (Section 23)	International Recognition Procedure (IRP)
Approval timeline	200–520 days	60–110 days
Application fee	NZD 132,000	GBP 35,305
Annual renewal	NZD 1,300	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	Sponsors must designate a New Zealand contact for pharmacovigilance and adverse event reporting to CARM (Centre for Adverse Reactions Monitoring, University of Otago) under Medsafe's PV requirements.	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, Provisional Consent (Section 23(1)(b)), Abbreviated Evaluation Procedure	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	Variations handled as Changed Medicine Notifications (CMNs) under Section 24 of the Medicines Act 1981. CMNs are categorised by impact (self-assessable Section 24(5)(a) notifications versus Section 24(5)(b) referrals requiring Medsafe assessment).	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	Consents granted under the Medicines Act 1981 do not have a fixed expiry; sponsors pay annual product fees and maintain the consent through ongoing compliance with conditions, CMNs and pharmacovigilance obligations.	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	MA holders must report adverse reactions to CARM under Medsafe's PV requirements (15-day for serious unlisted), submit PSURs aligned to ICH E2C(R2), and maintain RMPs for new active substances and biologics. Medsafe publishes Prescriber Update and safety communications.	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	Permitted	Permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	45–90 days	30–60 days
GCP standard	ICH E6(R2/R3) 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	Pharmac — Pharmacology and Therapeutics Advisory Committee (PTAC) and specialist subcommittees	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

New ZealandMedsafe
United KingdomMHRA

English submissions

New ZealandYes
United KingdomYes

CTD accepted

New ZealandYes
United KingdomYes

eCTD accepted

New ZealandYes
United KingdomYes

Reliance pathway

New ZealandAvailable
United KingdomAvailable

Reference agencies

New ZealandFDA, EMA, MHRA, TGA +2
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — New Medicine Application — Full Evaluation (Section 23) · International Recognition Procedure (IRP)

Pathway name

New ZealandNew Medicine Application — Full Evaluation (Section 23)
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

New Zealand200–520 days
United Kingdom60–110 days

Application fee

New ZealandNZD 132,000
United KingdomGBP 35,305

Annual renewal

New ZealandNZD 1,300
United KingdomGBP 0

Local representative

New ZealandRequired
United KingdomNot required

Local manufacturing

New ZealandNot required
United KingdomNot required

GMP inspection

New ZealandRequired
United KingdomNot required

MAH & local presence

Local entity required

New ZealandYes
United KingdomYes

Local responsible person

New ZealandYes
United KingdomYes

RP role

New ZealandSponsors must designate a New Zealand contact for pharmacovigilance and adverse event reporting to CARM (Centre for Adverse Reactions Monitoring, University of Otago) under Medsafe's PV requirements.
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

New Zealand3 designations
United Kingdom4 designations

Examples

New ZealandPriority Review, Provisional Consent (Section 23(1)(b)), Abbreviated Evaluation Procedure
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

Post-approval lifecycle

Variations framework

New ZealandVariations handled as Changed Medicine Notifications (CMNs) under Section 24 of the Medicines Act 1981. CMNs are categorised by impact (self-assessable Section 24(5)(a) notifications versus Section 24(5)(b) referrals requiring Medsafe assessment).
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

New ZealandConsents granted under the Medicines Act 1981 do not have a fixed expiry; sponsors pay annual product fees and maintain the consent through ongoing compliance with conditions, CMNs and pharmacovigilance obligations.
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

New ZealandMA holders must report adverse reactions to CARM under Medsafe's PV requirements (15-day for serious unlisted), submit PSURs aligned to ICH E2C(R2), and maintain RMPs for new active substances and biologics. Medsafe publishes Prescriber Update and safety communications.
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

New ZealandAvailable
United KingdomAvailable

Compassionate Use

New ZealandAvailable
United KingdomAvailable

Emergency Import

New ZealandAvailable
United KingdomAvailable

Parallel Import

New ZealandPermitted
United KingdomPermitted

Clinical trials

CTA approval

New ZealandRequired
United KingdomRequired

Ethics approval

New ZealandYes
United KingdomYes

CTA timeline

New Zealand45–90 days
United Kingdom30–60 days

GCP standard

New ZealandICH E6(R2/R3) GCP
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

New ZealandRegulated
United KingdomRegulated

Reference pricing

New ZealandYes
United KingdomNo

HTA required

New ZealandYes
United KingdomYes

HTA body

New ZealandPharmac — Pharmacology and Therapeutics Advisory Committee (PTAC) and specialist subcommittees
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)