Regulations for cell therapeutics

The cell therapeutics of the ITT are subject to the following legal bases:

• Act on the Trade in Medicinal Products(Medicinal Products Act - AMG)
• Law regulating the transfusion system(Transfusion Act - TFG)
• Law on the donation, removal and transfer of organs and tissues(Transplantation Act - TPG)
• Directive on the collection of blood and blood components and the use of blood products (Haemotherapy Directive)
• Guidelines on transplantation medicine
  • Directive pursuant to Section 16 para. 1 sentence 1 no. 4 a) and b) TPG concerning the requirements for the measures required in connection with organ removal for the protection of organ recipients (BÄK Recipient Protection Directive)
• Directive on the production and use of hematopoietic stem cell preparations
• Guideline on the quality assurance of laboratory medical examinations
• Cross-sectional guidelines (BÄK) on therapy with blood components and plasma derivatives
• EU guidelines for good manufacturing practices (GMP)
• Ordinance on the application of good manufacturing practice in the manufacture of medicinal products and active substances and on the application of good professional practice in the manufacture of products of human origin (AMWHV)
• Ordinance on the Quality and Safety Requirements for the Removal and Transfer of Tissues under the Transplantation Act (TPG-GewV)