SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang and Djamila Batache, Bär & Karrer Ltd
2.2 Securing Authorisation to Undertake a Clinical Trial In order to secure authorisation for the conduct of a clinical trial, the investigator must submit an applica- tion to the ethics committee in the canton in whose territory the study is conducted (Articles 24 et seq of the ClinO and Articles 10 et seq of the ClinO-MD). This is followed by: • acknowledgment of receipt/possible deficiencies’ notification within seven days (medicinal products) or ten days (medical devices); and • decision within 30 days (medicinal products) or 40 (medical devices) days and information of Swissmedic in the event that an authorisation by Swissmedic is necessary – in case of multi-centre clinical trials with medicinal products, the deadline is extended to 45 days. The submission of the application to Swissmedic is made by the sponsor – following which: • acknowledgement of receipt/possible deficiencies’ notification within seven (medicinal products) or ten (medical devices) days respectively; • as a general rule, decision within 30 days (medici- nal products) or 40 days (medical devices); and • in certain circumstances, Swissmedic must obtain the opinions from the Swiss Expert Committee for Biosafety (SECB), the Federal Office for the Envi- ronment (FOEN) or the FOPH before granting the authorisation. 2.3 Public Availability of the Conduct of a Clinical Trial Sponsors of authorised clinical trials with medicinal products are subject to registration obligations (Arti- cles 64–67 of the ClinO). Before conducting a clinical trial with medicinal products, the sponsor must enter the clinical trial either in a primary register recognised by the World Health Organization (WHO) or in the reg- ister of the National Library of Medicine of the United States of America as well as in the supplementary cantonal database using a Swiss national language. The publicly accessible portal SNCTP (Swiss National Clinical Trials Portal) displays studies that are being conducted in Switzerland as soon as they have been
The TPA further contains special provisions for blood and blood products (Articles 34 et seq of the TPA) as well as for veterinary medicinal products (Articles 42 et seq of the TPA). Medical devices are divided into different categories (classes I, IIa, IIb, III) – for which, different conformity assessment procedures apply. The classification fol- lows the respective regulation in the EU-MDR (Article 16 paragraph 1 of the MedDO) and is based on the intended purpose and the associated risk. Certain medical devices may be classified as intended for use by healthcare professionals (HCPs) only. Clinical trials are mainly governed by the TPA, the Human Research Act (HRA), the Human Research Ordinance (HRO), the Clinical Trials Ordinance (“Cli- nO”) and the Ordinance on Clinical Trials with Medical Devices (“ClinO-MD”). In principle, clinical trials with therapeutic products require prior authorisation from Swissmedic (Article 54 paragraph 1 of the TPA) and the competent ethics committee (Articles 24 et seq of the ClinO and Articles 9 et seq of the ClinO-MD). Regarding medicinal products, Swissmedic examines whether the good manufacturing practice (GMP) and safety requirements are met (Article 54 paragraph 4 lit a of the TPA). Regarding medical devices, the assess- ment includes the conformity of the products with the safety requirements (Article 54 paragraph 4 lit b of the TPA and Article 45 paragraphs 1 and 3 of the TPA). Clinical trials must be conducted in line with the rules of good clinical practice as set out, with regard to medicinal products, in the International Council for Harmonisation (ICH) Guideline on Good Clinical Practice of 9 November 2016 and the World Medical Association (WMA) Declaration of Helsinki on Ethi- cal Principles for Medical Research Involving Human Subjects (Article 5 paragraph 1 of the ClinO and Article 3 of the ClinO-MD). With regard to medical devices, the applicable rules on good clinical practice were incorporated into Swiss legislation by way of refer- ence to Article 72 and Annex XV Chapters I and III of the EU-MDR, as well as in EN ISO 14155. 2. Clinical Trials 2.1 Regulation of Clinical Trials
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