§ 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	🇸🇪Sweden	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	MPA (LV)	MHRA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	Available
Reference agencies	EMA (Centralised Procedure — directly valid), EU/EEA Member States (DCP / MRP), EU CMDh	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — EU Centralised Procedure · International Recognition Procedure (IRP)
Pathway name	EU Centralised Procedure	International Recognition Procedure (IRP)
Approval timeline	210–300 days	60–110 days
Application fee	EUR 350,000	GBP 35,305
Annual renewal	EUR 130,000	GBP 0
Local representative	Not required	Not required
Local manufacturing	Not required	Not required
GMP inspection	Required	Not required
MAH & local presence
Local entity required	No	Yes
Local responsible person	Yes	Yes
RP role	QPPV established in the EEA (any EEA member) per EU GVP Module I; QPPV is the contact for MPA pharmacovigilance. Swedish-language pharmacovigilance literature monitoring required for products marketed in Sweden. A Pharmacovigilance System Master File (PSMF) location must be declared.	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	4 designations	4 designations
Examples	Accelerated Assessment (EMA CP), Conditional Marketing Authorisation (CMA), PRIME (Priority Medicines) +1	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	EU variations framework (Commission Regulation 1234/2008 as amended) — Type IA / IAIN (do-and-tell), Type IB (tell-wait-do), Type II (prior approval), Extensions and Article 61(3) notifications. MPA processes variations for nationally / DCP / MRP authorised products; EMA processes variations for centrally-authorised products.	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	Standard renewal at 5 years post first authorisation; subsequent unlimited validity unless MPA / EMA decides on safety grounds to require further renewal. CMAs renewed annually until conversion to full MA.	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	EU pharmacovigilance framework (Directive 2010/84/EU and Regulation 1235/2010) implemented via Swedish Medicinal Products Act and MPA guidelines. EudraVigilance reporting mandatory; PSURs per EURD list submitted to EMA PSUSA. Swedish ADR reports collected by MPA via the national e-reporting portal (for healthcare professionals and consumers). MPA holds a PRAC seat. Strong epidemiological surveillance via Swedish national health registers (Patient Register, Prescribed Drug Register, Cancer Register).	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	60–106 days	30–60 days
GCP standard	ICH E6(R3) GCP; EU Clinical Trials Regulation 536/2014 (EU CTR); Swedish Medicinal Products Act and Ethical Review Act (Etikprövningslagen 2003:460)	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	No	No
HTA required	Yes	Yes
HTA body	Tandvårds- och läkemedelsförmånsverket (TLV — Dental and Pharmaceutical Benefits Agency) for outpatient prescription medicines and selected hospital medicines; NT-rådet (the New Therapies Council, hosted by the regions) makes national introduction recommendations for hospital medicines based on TLV health-economic assessments.	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

SwedenMPA (LV)
United KingdomMHRA

English submissions

SwedenYes
United KingdomYes

CTD accepted

SwedenYes
United KingdomYes

eCTD accepted

SwedenYes
United KingdomYes

Reliance pathway

SwedenAvailable
United KingdomAvailable

Reference agencies

SwedenEMA (Centralised Procedure — directly valid), EU/EEA Member States (DCP / MRP), EU CMDh
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — EU Centralised Procedure · International Recognition Procedure (IRP)

Pathway name

SwedenEU Centralised Procedure
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Sweden210–300 days
United Kingdom60–110 days

Application fee

SwedenEUR 350,000
United KingdomGBP 35,305

Annual renewal

SwedenEUR 130,000
United KingdomGBP 0

Local representative

SwedenNot required
United KingdomNot required

Local manufacturing

SwedenNot required
United KingdomNot required

GMP inspection

SwedenRequired
United KingdomNot required

MAH & local presence

Local entity required

SwedenNo
United KingdomYes

Local responsible person

SwedenYes
United KingdomYes

RP role

SwedenQPPV established in the EEA (any EEA member) per EU GVP Module I; QPPV is the contact for MPA pharmacovigilance. Swedish-language pharmacovigilance literature monitoring required for products marketed in Sweden. A Pharmacovigilance System Master File (PSMF) location must be declared.
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

Sweden4 designations
United Kingdom4 designations

Examples

SwedenAccelerated Assessment (EMA CP), Conditional Marketing Authorisation (CMA), PRIME (Priority Medicines) +1
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

Post-approval lifecycle

Variations framework

SwedenEU variations framework (Commission Regulation 1234/2008 as amended) — Type IA / IAIN (do-and-tell), Type IB (tell-wait-do), Type II (prior approval), Extensions and Article 61(3) notifications. MPA processes variations for nationally / DCP / MRP authorised products; EMA processes variations for centrally-authorised products.
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

SwedenStandard renewal at 5 years post first authorisation; subsequent unlimited validity unless MPA / EMA decides on safety grounds to require further renewal. CMAs renewed annually until conversion to full MA.
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

SwedenEU pharmacovigilance framework (Directive 2010/84/EU and Regulation 1235/2010) implemented via Swedish Medicinal Products Act and MPA guidelines. EudraVigilance reporting mandatory; PSURs per EURD list submitted to EMA PSUSA. Swedish ADR reports collected by MPA via the national e-reporting portal (for healthcare professionals and consumers). MPA holds a PRAC seat. Strong epidemiological surveillance via Swedish national health registers (Patient Register, Prescribed Drug Register, Cancer Register).
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

SwedenAvailable
United KingdomAvailable

Compassionate Use

SwedenAvailable
United KingdomAvailable

Emergency Import

SwedenAvailable
United KingdomAvailable

Parallel Import

SwedenPermitted
United KingdomPermitted

Clinical trials

CTA approval

SwedenRequired
United KingdomRequired

Ethics approval

SwedenYes
United KingdomYes

CTA timeline

Sweden60–106 days
United Kingdom30–60 days

GCP standard

SwedenICH E6(R3) GCP; EU Clinical Trials Regulation 536/2014 (EU CTR); Swedish Medicinal Products Act and Ethical Review Act (Etikprövningslagen 2003:460)
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

SwedenRegulated
United KingdomRegulated

Reference pricing

SwedenNo
United KingdomNo

HTA required

SwedenYes
United KingdomYes

HTA body

SwedenTandvårds- och läkemedelsförmånsverket (TLV — Dental and Pharmaceutical Benefits Agency) for outpatient prescription medicines and selected hospital medicines; NT-rådet (the New Therapies Council, hosted by the regions) makes national introduction recommendations for hospital medicines based on TLV health-economic assessments.
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)