Blood and blood products are medicinal products and as such are regulated by the Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA). Section 6 of Chapter 2 of the TPA contains special provisions relating to blood and blood products. Compliance with the regulations and ordinances resulting from the TPA is also required, e.g. good manufacturing practice (GMP) rules, quality management rules, and the Medicinal Products Licensing Ordinance (MPLO); consideration must also be given to the guidelines of the European Directorate for the Quality of Medicines and Healthcare (EDQM), the latest developments in science and technology and in this respect the obligation to exercise due diligence, as well as international guidelines.
Mandatory standards, recommendations, documents
The mandatory standards, called “prescriptions”, provide for the standardisation of manufacturing procedures, ensuring that the blood products are uniformly produced and tested and meet the specifications. These prescriptions cover the entire process chain, from donor care and support and blood donation to the manufacturing of blood products, donation analyses, release, quality management, product specifications and haemovigilance through to transport and delivery.
The rules are subject to regular review to verify conformance with legal requirements and with respect to the latest scientific and technological developments.
Swiss Transfusion SRC and the Swiss Association for Transfusion Medicine (SVTM/ASMT), in consultation with Swissmedic, has drawn up recommendations on immunohaematology and molecular testing of patient blood samples for clinical facilities, i.e. specialists, laboratories and medical institutions.
You will find all of the rules and recommendations here:
Blood stem cell donation
The following statutes and regulations are applicable in the area of blood stem cell donation:
- Transplantation Act (810.211) and Transplantation Ordinance (810.211)
- Standards of the World Marrow Donor Association (WMDA)
- Mandatory standards of Swiss Blood Stem Cells (SBSC), a department of Swiss Transfusion SRC
- Standards of the Joint Accreditation Committee-ISCT (Europe) & EBMT (JACIE)
- Mandatory standards of Swiss Transfusion SRC
The SBSC standards ensure that statutory requirements and those of the global organisation WMDA are reflected in practice. They cover the entire process chain, from donor recruitment, to confirmatory typing through to blood stem cell donation, quality management and vigilance, right through to transport and delivery.
These mandatory standards, called “prescriptions”, are regularly reviewed to verify conformance with legal requirements and with respect to the latest scientific and technological developments.
You can find more information at the WMDA website