Regulatory roadmap: Medicinal product, Switzerland

11 phases · 40 steps

This is the order in which Normiq organises market access for the market "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
Preclinical Development
Toxicology, pharmacology, and pharmacokinetic studies
1. Synthesis and characterization of the active substance
  required · 60 d
  Development of the active pharmaceutical ingredient (API)
2. Studies toxicologiques
  required · 90 d
  Acute, subacute, chronic toxicity, genotoxicity, carcinogenicity
3. Studies pharmacologiques
  required · 30 d
  Pharmacodynamics, pharmacokinetics, ADME
Phase 3
Authorisation Application d'clinical trial
IND (EU) ou application d'authorisation Swissmedic
1. Protocol clinical trial Phase I
  required · 20 d
  Define objectives, inclusion/exclusion criteria, endpoints
2. Investigator's Brochure (IB)
  required · 15 d
  Compile all available preclinical and clinical data
3. Soumettre la application CTA
  required · 25 d
  Submission to the competent authority and ethics committee
Phase 4
Clinical Trials Phase I
First-in-human administration - Safety and tolerability
1. Recruitment Phase I
  required · 30 d
2. Conduct de l'essai Phase I
  required · 120 d
  Dose escalation, close monitoring
3. Phase I Results Analysis
  required · 30 d
Phase 5
Clinical Trials Phase II
Preliminary efficacy and dose determination
1. Protocol Phase II
  required · 30 d
2. Application authorisation Phase II
  required · 20 d
3. Recruitment Phase II
  required · 90 d
4. Conduct essai Phase II
  required · 180 d
5. Analysis Phase II
  required · 45 d
Phase 6
Clinical Trials Phase III
Confirmed efficacy and safety - Pivotal trials
1. Protocols Phase III
  required · 60 d
  Generally 2 independent pivotal trials
2. Authorisation Phase III
  required · 30 d
3. Recruitment Phase III
  required · 180 d
4. Conduct essais Phase III
  required · 365 d
5. Analysis statistique Phase III
  required · 95 d
Phase 7
Pharmaceutical Development et production
Dosage form development and scale-up
1. Formulation development
  required · 120 d
  Dosage form, excipients, stability
2. Studies de stabilité
  required · 180 d
  Accelerated and long-term stability per ICH Q1A
3. Manufacturing process validation
  required · 65 d
  Scale-up validation, quality controls
Phase 8
GMP Certification
Bonnes Pratiques de Fabrication - Mandatory
1. GMP Compliance
  required · 60 d
  Infrastructure, equipment, GMP procedures
2. GMP Inspection
  required · 60 d
  Inspection by the competent authority
Phase 9
CTD Dossier Compilation
Common Technical Document - Standardized ICH format
1. Module 1 - Administrative Data
  required · 10 d
2. Module 2 - Summaries
  required · 20 d
  Quality, non-clinical, and clinical summaries
3. Module 3 - Quality (CMC)
  required · 20 d
  Chemistry, Manufacturing, Controls
4. Module 4 - Non-clinical Reports
  required · 20 d
5. Module 5 - Clinical Reports
  required · 20 d
Phase 10
Marketing Authorisation Application (AMM)
Marketing Authorization Application (MAA) via EMA or national procedure
1. Submission du dossier AMM
  required · 10 d
  Submission du dossier CTD complet
2. Authority Evaluation
  required · 300 d
  EMA/ANSM assessment (210 days with clock stop)
3. Responses to questions
  required · 40 d
  Respond to authority questions (list of questions)
4. Obtaining the Marketing Authorisation
  required · 15 d
  Marketing authorization granted
Phase 11
Pharmacovigilance and post-MA surveillance
Mandatory pharmacovigilance system
1. Set up the pharmacovigilance system
  required · 15 d
  QPPV (Qualified Person for Pharmacovigilance), procedures
2. Risk Management Plan (RMP)
  required · 10 d
  Risk Management Plan - Document mandatory
3. PSUR (Periodic Safety Update Report)
  required · 5 d
  Periodic safety reports

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, 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

Preclinical Development

Synthesis and characterization of the active substance

Studies toxicologiques

Studies pharmacologiques

Authorisation Application d'clinical trial

Protocol clinical trial Phase I

Investigator's Brochure (IB)

Soumettre la application CTA

Clinical Trials Phase I

Recruitment Phase I

Conduct de l'essai Phase I

Phase I Results Analysis

Clinical Trials Phase II

Protocol Phase II

Application authorisation Phase II

Recruitment Phase II

Conduct essai Phase II

Analysis Phase II

Clinical Trials Phase III

Protocols Phase III

Authorisation Phase III

Recruitment Phase III

Conduct essais Phase III

Analysis statistique Phase III

Pharmaceutical Development et production

Formulation development

Studies de stabilité

Manufacturing process validation

GMP Certification

GMP Compliance

GMP Inspection

CTD Dossier Compilation

Module 1 - Administrative Data

Module 2 - Summaries

Module 3 - Quality (CMC)

Module 4 - Non-clinical Reports

Module 5 - Clinical Reports

Marketing Authorisation Application (AMM)

Submission du dossier AMM

Authority Evaluation

Responses to questions

Obtaining the Marketing Authorisation

Pharmacovigilance and post-MA surveillance

Set up the pharmacovigilance system

Risk Management Plan (RMP)

PSUR (Periodic Safety Update Report)

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