§ 02 · Comparison
Compare regulatory pathways side-by-side
Benchmark MAHMAH, GMPGMP, HTAHTA and pathway requirements across up to three markets.
Lead pathway (timeline & fees), New Medicine Application, Full Evaluation (Section 23) · Centralised Procedure
Pathway name
- New ZealandNew Medicine Application, Full Evaluation (Section 23)
- European UnionCentralised Procedure
Approval timeline
- New Zealand200-520 days
- European Union210-277 days
Headline fee and pathway
- New ZealandNZD 106,503, New Medicine Application, Full Evaluation (Section 23)conditional on tax
- European UnionEUR 865,200, Centralised Procedureconditional on other
Recurring charges
- New ZealandNo recurring fee
- European UnionEUR 232,400 a year, per marketing authorisation, other applications
Local representative
- New ZealandRequired
- European UnionRequired
Local manufacturing
- New ZealandNot required
- European UnionNot required
GMP inspection
- New ZealandRequired
- European UnionRequired
MAH & local presence
Local entity required
- New ZealandYes
- European UnionYes
Local responsible person
- New ZealandYes
- European UnionYes
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.
- 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
- New Zealand3 designations
- European Union6 designations
Examples
- New ZealandPriority Review, Provisional Consent (Section 23(1)(b)), Abbreviated Evaluation Procedure
- European UnionAccelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3
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).
- 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 to 90 days), and Extensions (Annex I changes, full review). Worksharing procedures consolidate 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.
- 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
- 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.
- 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
- New ZealandAvailable
- European UnionAvailable
Compassionate Use
- New ZealandAvailable
- European UnionAvailable
Emergency Import
- New ZealandAvailable
- European UnionAvailable
Parallel Import
- New ZealandPermitted
- European UnionPermitted
Clinical trials
CTA approval
- New ZealandRequired
- European UnionRequired
Ethics approval
- New ZealandYes
- European UnionYes
CTA timeline
- New Zealand45-90 days
- European Union60-106 days
GCP standard
- New ZealandICH E6(R2/R3) GCP
- European UnionICH E6(R3), Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025
Pricing & reimbursement
Price regulation
- New ZealandRegulated
- European UnionRegulated
Reference pricing
- New ZealandYes
- European UnionYes
HTA required
- New ZealandYes
- European UnionYes
HTA body
- New ZealandPharmac, Pharmacology and Therapeutics Advisory Committee (PTAC) and specialist subcommittees
- European UnionEU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)