Quote from VigiServe Admin on November 29, 2020, 6:58 AM

Pharmacovigilance Guideline

In Switzerland, Pharmacovigilance is managed by Swissmedic under the Therapeutic Products Act (TPA) and Ordinance (TPO/AMBV). While Switzerland is not an EU member, its practices pragmatically align with ICH standards and EU GVP modules where specified, though national law prevails.

1. Clinical Safety (Clinical Trials)

Regulated by the Clinical Trials Ordinance (ClinO, 2014). Switzerland does not participate in the EU CTIS/CTR; submissions are national.

• Expedited Reporting (SUSARs): Sponsors must report Suspected Unexpected Serious Adverse Reactions from Swiss sites:

  • Fatal or Life-Threatening: Within 7 days.

  • Other Serious Unexpected: Within 15 days.

  • Foreign SUSARs: Not reported individually; aggregated in the annual report.

• Investigator Reporting: Serious Adverse Events (SAEs) must be reported to the Sponsor within 24 hours.

• Periodic Reporting: An Annual Safety Report (ASR) (similar to ICH E2F/DSUR) listing SAEs/SUSARs with a risk-benefit assessment is mandatory.

• Submission: Direct to Swissmedic and the relevant Ethics Committee.

2. Post-Marketing Pharmacovigilance

• Personnel (RPV):

  • Qualified Person (RPV): Mandatory per TPA Art. 59. Must have documented PV expertise.

  • Residence: No requirement to reside in Switzerland or the EEA.

  • Affiliation: Can be an external contractor, provided responsibilities are defined in writing.

• Documentation: A PV system (similar to PSMF) must be maintained and available for inspection.

• Incident Reporting (ICSRs):

  • Serious/Unexpected: Report within 15 days.

  • Non-Serious: Report within 60 days.

  • Quality Defects: 24 hours (Class I), 3 days (Class II), 15 days (Class III).

  • Platform: Electronic reporting via ElViS (E2B preferred).

• Risk & Periodic Reporting:

  • PSURs/PBRERs: Aligns with ICH E2C(R2). Frequency is determined by authorization conditions (often 6-months/annual).

  • RMPs: Mandatory for new or high-risk products (aligned with EU GVP V); a Swiss Annex may be required.

Summary of Requirements

Component	Requirement in Switzerland
Regulatory Authority	Swissmedic
Qualified Person (RPV)	Mandatory (No residency requirement)
PSMF	Required (Maintained for inspection)
SUSAR Reporting	7 days (fatal) / 15 days (other serious) – Swiss sites only
ICSR Timelines	15 days (serious) / 60 days (non-serious)
RMPs & PSURs	Mandatory; aligns with ICH/EU GVP