Table 2.

Comparative overview of selected and notable applicable legal and regulatory framework documents covering the development and practices of autologous and allogeneic cell therapy in Switzerland and in the European Union. High similarity existed in definitions, requirements, and possibilities between both considered and neighboring jurisdictions. It was noteworthy that in several instances, the European documents were applicable in part by extension to Switzerland. Most aspects concerning specific technical requirements for cellular therapies in Switzerland were derived from international (e.g., ISO, ICH), European (e.g., EMA, EDQM), and American (e.g., FDA) official sources. EC, European Commission; EDQM, European Directorate for the Quality of Medicines and Healthcare; EMA, European Medicines Agency; FDA, US Food and Drug Administration; ICH, International Council for Harmonization; ISO, International Organization for Standardization.

Legal/Regulatory Texts in Switzerland	Legal/Regulatory Texts in the European Union
Federal law on the transplantation of organs, tissues, and cells (Law on Transplantation, 2004)	Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells (2004)
Federal law on medication and medical devices (Law on Therapeutic Products, LPTh, 2000)	Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use (2001)
Federal ordinance on authorizations in the domain of therapeutic products (OAMéd, 2018)	Regulation (EC) No. 1394/2007 on Advanced Therapy Medicinal Products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004 (2007)