12. Resources

Swiss Authorities

Swissmedic (Health Authority)

https://www.swissmedic.ch/swissmedic/en/home.html 

Swissethics (Swiss Association of Research Ethics Committees)

https://swissethics.ch/en/

Federal Office of Public Health (FOPH):

https://www.bag.admin.ch/bag/en/home.html

Swiss Expert Committee for Biosafety (SECB)

https://www.efbs.admin.ch/en/topics/gene-therapy

KOFAM- Swiss Federal Office of Public Health’s portal for human research

https://www.kofam.ch/en  

Swiss Laws

NB: English is not an official language of the Swiss Confederation. The English language versions provided below, although originating from Swissmedic and Swissethics, are provided by them “for information purposes only and has no legal force”.

Human Research Act (HRA)

https://www.fedlex.admin.ch/eli/cc/2013/617/en   

Therapeutic Product Act (TPA)

https://www.fedlex.admin.ch/eli/cc/2001/422/de 

Clinical Trials Ordinance “ClinO”

https://www.fedlex.admin.ch/eli/cc/2013/643/en#annex_3

Federal Data Protection Act (FAD)

https://www.fedlex.admin.ch/eli/cc/2022/491/en 

Federal Act of Administrative Procedure (APA)

https://www.fedlex.admin.ch/eli/cc/1969/737_757_755/en 

Federal Act on Electronic Signatures, ESigA, SR 943.03

https://www.sas.admin.ch/sas/en/home/akkreditiertestellen/akkrstellensuchesas/pki1.html 

Swiss Regulatory Guidance

Swissethics - Position Papers

https://swissethics.ch/en/themen/positionspapiere

Swissmedic - Clinical Trial Application

https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/clinical-trials/clinical-trials-on-medicinal-products/clinical-trial-application.html  

Swissmedic and Swissethics - Position paper on decentralized clinical trials (DCTs) with medicinal products

https://www.swissmedic.ch/dam/swissmedic/en/dokumente/bewilligungen/klv/positionspapier-dct.pdf.download.pdf/DCT_EN_.pdf 

Swissethics

Conception and application of an electronic informed consent, last updated 23 Aug 2019

https://swissethics.ch/assets/studieninformationen/guidance_e_consent_e.pdf

Swissethics- Related to Insurance

https://swissethics.ch/en/aktuell 

Submission portals

Swissmedic- eGov Submission Portal

https://www.swissmedic.ch/swissmedic/en/home/services/egov-portal.html  

BASEC - (Business Administration System for Ethics Committees)

https://swissethics.ch/basec 

Relates to the Cantonal ECs

Conference of Cantonal Ministers of Public Health

http://www.gdk-cds.ch/ 

Central Ethics Committee

https://www.samw.ch/de/Portraet/Kommissionen/Zentrale-Ethikkommission.html  

Kantonale Ethikkommission Bern (Canton of Bern)

https://www.gsi.be.ch/de/start/ueber-uns/kommissionen-gsi/ethikkommission.html 

Ethikkommission Nordwest- und Zentralschweiz EKNZ -(Northwestern and central Switzerland)

https://www.eknz.ch/ 

Ethikkommission Ostschweiz EKOS (Ethics Committee, Eastern Switzerland Kanton St Gallen)

https://www.sg.ch/gesundheit-soziales/gesundheit/gremien.html 

Ethics Committee Geneva

https://www.ge.ch/ccer-obtenir-autorisation-recherche-medicale-etre-humain 

Ethics Committee (Caton Ticino)

https://www4.ti.ch/dss/dsp/us/ce/comitato 

Ethics Committee- Cantonal Commission of the research on the CER-VD (Canton Vaud)

https://www.cer-vd.ch 

Ethics Committee- Canton of Zurick

https://www.zh.ch/de/gesundheitsdirektion/ethikkommission.html 

Relates to Data

Federal Data Protection and Information Commissioner: Cross-border transfer of personal data

https://www.edoeb.admin.ch/edoeb/en/home/datenschutz/arbeit_wirtschaft/datenuebermittlung_ausland.html

Data Transfers: 

“Guide to checking the admissibility of direct and indirect data transfers to foreign countries”

https://www.edoeb.admin.ch/dam/edoeb/en/dokumente/datenschutz/Anleitung%20f%C3%BCr%20die%20Pr%C3%BCfung%20von%20Daten%C3%BCbermittlungen%20mit%20Auslandbezug%20EN.pdf.download.pdf/Anleitung%20f%C3%BCr%20die%20Pr%C3%BCfung%20von%20Daten%C3%BCbermittlungen%20mit%20Auslandbezug%20EN.pdf

Trade Associations and Codes:

Swiss Clinical Trial Organization (SCTO)

https://www.scto.ch/de.html 

Interpharma

https://www.interpharma.ch/?lang=en 

Interpharma Pharma Cooperation Code

https://www.interpharma.ch/themen/der-patient-im-mittelpunkt/arzneimittelherstellung/pharmakodex/?lang=en

EFPIA

https://www.efpia.eu 

EFPIA Code

https://www.efpia.eu/relationships-code/the-efpia-code/

Pharma Cooperation Code (PCC)

https://www.interpharma.ch/themen/der-patient-im-mittelpunkt/arzneimittelherstellung/pharmakodex/?lang=en

EU Directives

Annex VIII to Directive 93/42/EEC

https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF 

Annex 6 to Directive 90/385/EEC

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31990L0385&from=EN 

International Standards

ICH E6 (R2)

https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practic

ISO 14155

https://www.iso.org/standard/71690.html