Annex 1 Revised by No I of the FDHA Ordinance of 24 March 2017 (AS 2017 2439), Annex No 1 of the O of 25 Oct. 2017 (AS 2017 5935), No II para. 1 of the O of 7 June 2024 (AS 2024 322) and No I of the FDHA O of 3 July 2025, in force since 15 Aug. 2025 (AS 2025 462).
(Art. 3, 5, 19, 39–42)
Rules and classifications
1 Guidelines on scientific integrity
The applicable guidelines are the code of conduct for scientific integrity, issued by the Swiss Academies of Arts and Sciences, in the version dated May 2021163.
2 Rules of Good Clinical Practice
The applicable rules of Good Clinical Practice are:
for clinical trials of medicinal products and transplant products: the Guideline for Good Clinical Practice issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, in the version dated 6 January 2025164 (ICH-GCP E6 [R3] Guideline);
for clinical trials of products under Article 2a paragraph 2 TPA: Annexes VIII and X to Directive 93/42/EEC165 and Annexes 6 and 7 to Directive 90/385/EEC166 and the requirements specified in EN ISO 14155:2011167. The definition of serious adverse events in accordance with Article 42 is based on the Guidelines on Medical Devices (MEDDEV 2.7/3) of May 2015168;
for clinical trials as specified in Chapters 3 and 4: the ICH Guideline mutatis mutandis.
3 International Classification of Diseases
The applicable classification is the 2010 version of the International Classification of Diseases issued by the World Health Organization (WHO) (ICD-10)169; the relevant disease groups are those identified by three-character codes.