§ 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 Korea	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	MFDS	MHRA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	None	Available
Reference agencies	FDA, EMA, MHRA, PMDA +3	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — New Drug Application — Standard Review · International Recognition Procedure (IRP)
Pathway name	New Drug Application — Standard Review	International Recognition Procedure (IRP)
Approval timeline	365–480 days	60–110 days
Application fee	KRW 8,500,000	GBP 35,305
Annual renewal	KRW 1,500,000	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	Qualified Person for Safety Management (안전관리책임자): Korea-resident pharmacist responsible for pharmacovigilance and post-marketing safety obligations. A separate Quality Manager is required for manufacturing/import licences.	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	5 designations	4 designations
Examples	Global Innovative Products on Fast Track (GIFT), Priority Review, Conditional Approval +2	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	MFDS classifies post-approval changes as Major, Moderate, and Minor variations, broadly aligned with EU classification. Annual report categories also exist for the smallest changes.	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 require renewal every 5 years. Renewal application must be submitted 6 months before expiry. Re-examination period (재심사기간) of 4–6 years applies to new drugs requiring active safety monitoring with full re-evaluation.	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	Korea Adverse Event Reporting System (KAERS) administered by the Korea Institute of Drug Safety and Risk Management (KIDS). PSURs aligned with ICH E2C(R2). MAH must appoint a Qualified Person for Safety Management and maintain a pharmacovigilance system.	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	30–60 days	30–60 days
GCP standard	Korean GCP (KGCP, ICH E6(R3) aligned)	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	Health Insurance Review and Assessment Service (HIRA) — Pharmaceutical Benefits Coverage Assessment Committee	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 KoreaMFDS
United KingdomMHRA

English submissions

South KoreaYes
United KingdomYes

CTD accepted

South KoreaYes
United KingdomYes

eCTD accepted

South KoreaYes
United KingdomYes

Reliance pathway

South KoreaNone
United KingdomAvailable

Reference agencies

South KoreaFDA, EMA, MHRA, PMDA +3
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — New Drug Application — Standard Review · International Recognition Procedure (IRP)

Pathway name

South KoreaNew Drug Application — Standard Review
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

South Korea365–480 days
United Kingdom60–110 days

Application fee

South KoreaKRW 8,500,000
United KingdomGBP 35,305

Annual renewal

South KoreaKRW 1,500,000
United KingdomGBP 0

Local representative

South KoreaRequired
United KingdomNot required

Local manufacturing

South KoreaNot required
United KingdomNot required

GMP inspection

South KoreaRequired
United KingdomNot required

MAH & local presence

Local entity required

South KoreaYes
United KingdomYes

Local responsible person

South KoreaYes
United KingdomYes

RP role

South KoreaQualified Person for Safety Management (안전관리책임자): Korea-resident pharmacist responsible for pharmacovigilance and post-marketing safety obligations. A separate Quality Manager is required for manufacturing/import licences.
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 Korea5 designations
United Kingdom4 designations

Examples

South KoreaGlobal Innovative Products on Fast Track (GIFT), Priority Review, Conditional Approval +2
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

Post-approval lifecycle

Variations framework

South KoreaMFDS classifies post-approval changes as Major, Moderate, and Minor variations, broadly aligned with EU classification. Annual report categories also exist for the smallest changes.
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 KoreaMarketing authorisations require renewal every 5 years. Renewal application must be submitted 6 months before expiry. Re-examination period (재심사기간) of 4–6 years applies to new drugs requiring active safety monitoring with full re-evaluation.
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 KoreaKorea Adverse Event Reporting System (KAERS) administered by the Korea Institute of Drug Safety and Risk Management (KIDS). PSURs aligned with ICH E2C(R2). MAH must appoint a Qualified Person for Safety Management and maintain a pharmacovigilance system.
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 KoreaAvailable
United KingdomAvailable

Compassionate Use

South KoreaAvailable
United KingdomAvailable

Emergency Import

South KoreaAvailable
United KingdomAvailable

Parallel Import

South KoreaNot permitted
United KingdomPermitted

Clinical trials

CTA approval

South KoreaRequired
United KingdomRequired

Ethics approval

South KoreaYes
United KingdomYes

CTA timeline

South Korea30–60 days
United Kingdom30–60 days

GCP standard

South KoreaKorean GCP (KGCP, ICH E6(R3) aligned)
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

South KoreaRegulated
United KingdomRegulated

Reference pricing

South KoreaYes
United KingdomNo

HTA required

South KoreaYes
United KingdomYes

HTA body

South KoreaHealth Insurance Review and Assessment Service (HIRA) — Pharmaceutical Benefits Coverage Assessment Committee
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)