Regulatory roadmap: Medicinal product, European Union and Switzerland

11 phases · 44 steps

This is the order in which Normiq organises market access for the market "European Union and Switzerland" and the category "Medicinal product". Each step has a detailed guide — how to proceed, best practices, common mistakes, reference articles — reserved for Normiq accounts.

Phase 1
Integrity and transparency (Switzerland)
Swiss obligations governing advantages granted to healthcare professionals and the transparency of discounts. Concerns sales and marketing as much as regulatory affairs.
1. Switzerland — determine whether transparency applies to you
  required · 10 d
  Establish whether your products and commercial practices fall within Art. 55 and 56 of the Therapeutic Products Act.
2. Switzerland — account for discounts and rebates
  required · 20 d
  Discounts and rebates must appear in supporting documents, accounts and books, and be disclosed to the Federal Office of Public Health on request.
3. Switzerland — set up internal control arrangements
  required · 30 d
  A designated person, ten years of retention for agreements, and a list of those who received lawful advantages.
4. Switzerland — congresses, training and paid services
  required · 20 d
  Hard thresholds: an own contribution of one third or one fifth, meals capped at CHF 100, advantages of modest value capped at CHF 300 a year.
Phase 2
Molecule Discovery
Therapeutic target identification and drug candidate development
1. Therapeutic Target Identification
  required · 270 d
  Identification of a molecular target (protein, receptor, enzyme) involved in a pathology
2. Screening and Hit Identification
  required · 225 d
  High-throughput screening (HTS) of compound libraries to identify active molecules
3. Lead Optimization
  required · 635 d
  Chemical modification of hits to improve potency, selectivity and pharmacokinetic properties
Phase 3
Preclinical Development
Toxicology, pharmacology, and pharmacokinetic studies
1. Studies de pharmacologie in vitro
  required · 225 d
  Characterization of the pharmacological activity of the drug candidate in cellular models
2. Studies de pharmacologie in vivo
  required · 270 d
  Efficacy studies on animal models of the disease
3. GLP genotoxicity (in vitro and in vivo)
  required · 105 d
  Ames test, chromosomal aberrations, micronucleus test
4. GLP 28-day repeated-dose toxicity
  required · 126 d
  GLP 28-day toxicity study (rodents and non-rodents)
5. Safety pharmacology (hERG, QTc)
  required · 135 d
  Studies cardio-vasculaires, respiratoires, SNC
6. Pharmacokinetic (PK) and ADME Studies
  required · 225 d
  Absorption, distribution, metabolism, excretion in animals
7. CMC/Quality Development (Module 3)
  required · 450 d
  Manufacturing process development, quality controls, stability
Phase 4
Application d'clinical trial (CTA CH + EU)
Parallel submission: CTIS (EU) and Swissmedic (CH)
1. Preparation dossier IND/CTA (Modules 2-5)
  required · 105 d
  Dossier CTD Modules 2, 3, 4 + protocol clinique + brochure investigateur
2. CTIS Submission (European Union)
  required · 90 d
  Submission via Clinical Trial Intraining System (CTIS) pour sites EU
3. Submission Swissmedic (Switzerland)
  required · 75 d
  Submission CTA via portail eSubmission Swissmedic pour sites CH
4. CTA evaluation and approval (CH + EU)
  required · 90 d
  Obtain approvals from Swissmedic and EU authorities (MSC)
Phase 5
Clinical Trial Phase I (CH + EU)
First-in-Human - Safety and tolerability (CH and/or EU sites)
1. First-in-Human (FIH) - Dose escalation
  required · 270 d
  First human administration, cautious dose escalation
2. Studies PK/PD Phase I
  required · 135 d
  Pharmacokinetics, pharmacodynamics, drug-drug interaction, food effect
Phase 6
Clinical Trial Phase II (CH + EU)
Proof of concept and dose determination (multinational trials)
1. Phase IIa - Proof of Concept (PoC)
  required · 545 d
  First efficacy evaluation on a small patient cohort (100-200)
2. Phase IIb - Dose-finding
  required · 550 d
  Determination of the optimal dose for Phase III (200-300 patients)
Phase 7
Clinical Trial Phase III (CH + EU)
Studies pivotales multicentriques - Base de l'AMM
1. Studies pivotales Phase III (2 essais minimum)
  required · 1095 d
  Multicenter randomized controlled trials (300-3000+ patients)
2. Long-Term Safety Studies
  required · 365 d
  Collection of safety data under prolonged exposure
3. Studies de toxicologie chronique (si indication chronique)
  recommended · 910 d
  6-12 month toxicity, carcinogenicity based on intended treatment duration
Phase 8
GMP Certification (CH + EU)
GMP Certification avec reconnaissance mutuelle Switzerland-EU (MRA)
1. GMP Compliance (EU GMP / PIC/S)
  required · 455 d
  Site compliance with EU GMP standards (EudraLex Vol 4) and PIC/S GMP
2. GMP Inspection et certification
  required · 150 d
  Inspection by the competent authority (Swissmedic OR an EU authority)
3. Registration EudraGMDP (pour dossier EU)
  required · 35 d
  Swissmedic enters GMP data into the EudraGMDP database
Phase 9
Preparation dossiers CTD/eCTD (CH + EU)
MA dossier compilation - Modules 2-5 identical, Module 1 different
1. Compilation of CTD Modules 2-5 (common CH + EU)
  required · 635 d
  Module 2: Summaries / Module 3: Quality CMC / Module 4: Non-Clinical / Module 5: Clinical
2. Preparation Module 1 - EU (SmPC, PIL)
  required · 105 d
  EU-specific Module 1: EMA forms, SmPC, Patient Information Leaflet
3. Preparation Module 1 - CH (Fachintraining)
  required · 105 d
  Switzerland-specific Module 1: Swissmedic forms, Fachinformation, patient information
4. eCTD conversion (CH + EU)
  required · 75 d
  Conversion of both dossiers (CH and EU) into electronic eCTD format
5. Pre-submission meetings (EMA + Swissmedic)
  recommended · 75 d
  Pre-submission meetings with EMA (7 months in advance) and Swissmedic
Phase 10
MA Submission and Evaluation (CH + EU)
PARALLEL submission to EMA and Swissmedic — Major time savings
1. MAA Submission to EMA (Centralised Procedure)
  required · 30 d
  Submission of complete eCTD dossier via EMA centralized procedure
2. MA Submission to Swissmedic (Standard Procedure)
  required · 30 d
  Submission of eCTD dossier via the Swissmedic portal
3. EMA evaluation by CHMP
  required · 375 d
  CHMP assessment: 210 active days + response time (LoQ)
4. European Commission approval
  required · 67 d
  Final European Commission decision following CHMP opinion
5. Swissmedic evaluation (standard procedure)
  required · 330 d
  Quality, safety and efficacy assessment by Swissmedic
6. Obtention AMM Switzerland
  required · 15 d
  Marketing authorisation issued by Swissmedic
Phase 11
Post-authorisation et pharmacovigilance (CH + EU)
Harmonized CH + EU pharmacovigilance system
1. EU pharmacovigilance system (PSMF)
  required · 75 d
  PSMF (Pharmacovigilance System Master File) + EU/EEA-based QPPV
2. CH pharmacovigilance system (Swissmedic)
  required · 75 d
  Qualified person responsible for adverse reaction reporting (Art. 59 TPA)
3. Risk Management Plan (RMP) - ICH E2E
  required · 30 d
  Harmonized CH + EU risk management plan
4. Periodic Safety Update Reports (PSURs)
  required · 30 d
  Periodic safety reports (6 months initially, then annually, then every three years)
5. MA renewal (CH + EU)
  required · 135 d
  Renewal after 5 years (EU) or per MA terms (CH)

The detailed guide for each step — how to proceed, best practices, common mistakes — is reserved for Normiq accounts.

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Regulatory roadmap: Medicinal product, European Union and Switzerland

Integrity and transparency (Switzerland)

Switzerland — determine whether transparency applies to you

Switzerland — account for discounts and rebates

Switzerland — set up internal control arrangements

Switzerland — congresses, training and paid services

Molecule Discovery

Therapeutic Target Identification

Screening and Hit Identification

Lead Optimization

Preclinical Development

Studies de pharmacologie in vitro

Studies de pharmacologie in vivo

GLP genotoxicity (in vitro and in vivo)

GLP 28-day repeated-dose toxicity

Safety pharmacology (hERG, QTc)

Pharmacokinetic (PK) and ADME Studies

CMC/Quality Development (Module 3)

Application d'clinical trial (CTA CH + EU)

Preparation dossier IND/CTA (Modules 2-5)

CTIS Submission (European Union)

Submission Swissmedic (Switzerland)

CTA evaluation and approval (CH + EU)

Clinical Trial Phase I (CH + EU)

First-in-Human (FIH) - Dose escalation

Studies PK/PD Phase I

Clinical Trial Phase II (CH + EU)

Phase IIa - Proof of Concept (PoC)

Phase IIb - Dose-finding

Clinical Trial Phase III (CH + EU)

Studies pivotales Phase III (2 essais minimum)

Long-Term Safety Studies

Studies de toxicologie chronique (si indication chronique)

GMP Certification (CH + EU)

GMP Compliance (EU GMP / PIC/S)

GMP Inspection et certification

Registration EudraGMDP (pour dossier EU)

Preparation dossiers CTD/eCTD (CH + EU)

Compilation of CTD Modules 2-5 (common CH + EU)

Preparation Module 1 - EU (SmPC, PIL)

Preparation Module 1 - CH (Fachintraining)

eCTD conversion (CH + EU)

Pre-submission meetings (EMA + Swissmedic)

MA Submission and Evaluation (CH + EU)

MAA Submission to EMA (Centralised Procedure)

MA Submission to Swissmedic (Standard Procedure)

EMA evaluation by CHMP

European Commission approval

Swissmedic evaluation (standard procedure)

Obtention AMM Switzerland

Post-authorisation et pharmacovigilance (CH + EU)

EU pharmacovigilance system (PSMF)

CH pharmacovigilance system (Swissmedic)

Risk Management Plan (RMP) - ICH E2E

Periodic Safety Update Reports (PSURs)

MA renewal (CH + EU)

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