§ 02 · Comparison
Compare regulatory pathways side-by-side
Benchmark MAHMAH, GMPGMP, HTAHTA and pathway requirements across up to three markets.
Lead pathway (timeline & fees), EU Centralised Procedure · Centralised Procedure
Pathway name
- SwedenEU Centralised Procedure
- European UnionCentralised Procedure
Approval timeline
- Sweden210-300 days
- European Union210-277 days
Headline fee and pathway
- SwedenEUR 865,200, EU Centralised Procedure
- European UnionEUR 865,200, Centralised Procedureconditional on other
Recurring charges
- SwedenEUR 232,400 a year, per marketing authorisation
- European UnionEUR 232,400 a year, per marketing authorisation, other applications
Local representative
- SwedenNot required
- European UnionRequired
Local manufacturing
- SwedenNot required
- European UnionNot required
GMP inspection
- SwedenRequired
- European UnionRequired
MAH & local presence
Local entity required
- SwedenNo
- European UnionYes
Local responsible person
- SwedenYes
- European UnionYes
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.
- 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
- Sweden4 designations
- European Union6 designations
Examples
- SwedenAccelerated Assessment (EMA CP), Conditional Marketing Authorisation (CMA), PRIME (Priority Medicines) +1
- European UnionAccelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3
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.
- 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
- 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.
- 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
- 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).
- 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
- SwedenAvailable
- European UnionAvailable
Compassionate Use
- SwedenAvailable
- European UnionAvailable
Emergency Import
- SwedenAvailable
- European UnionAvailable
Parallel Import
- SwedenPermitted
- European UnionPermitted
Clinical trials
CTA approval
- SwedenRequired
- European UnionRequired
Ethics approval
- SwedenYes
- European UnionYes
CTA timeline
- Sweden60-106 days
- European Union60-106 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)
- European UnionICH E6(R3), Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025
Pricing & reimbursement
Price regulation
- SwedenRegulated
- European UnionRegulated
Reference pricing
- SwedenNo
- European UnionYes
HTA required
- SwedenYes
- European UnionYes
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.
- European UnionEU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)