PAS 83:2012 Developing human cells for clinical applications in the European Union and the United States of America – Guide
This Publicly Available Specification (PAS) gives guidance by providing a quick reference source, to increase clarity for users on the requirements needed for exploitation of cell therapy products.
The main focus of this PAS are cell based medicinal products (CBMPs) that are regulated as advanced therapy medicinal products (ATMP) in the EU and biologics (351 HCT/P) in the US. However, for completeness aspects of minimally manipulated, homologous use products (also known as 361 HCT/P in the US) are also covered.
This PAS will act as a guide to point users in the direction of the relevant EU and US legislation, guidance documents, pharmacopoeial chapters and monographs.
NOTE 1 Since the implementation of EU Directives varies between Member States it is not possible to provide specific national details of how legislation is enacted around the EU.
NOTE 2 Where national differences exist this will be indicated in the text. This PAS is intended for use by organizations and individuals with an interest in the development of human cells for clinical applications including academic groups, small and medium sized enterprises (SMEs) and larger industrial manufacturers and the general public. For researchers new to the field, this PAS will give an appreciation of the level of regulation, guidance and associated quality issues that apply to cell therapy products.
This PAS does not cover:
- solid organ transplantation or blood transfusions;
- blood products (e.g. serum, plasma, erythrocytes and platelets);
- xenogeneic products and xenogeneic feeder cells, although much of the text will be broadly applicable;
- combination products, although the text will still be applicable to the cellular component, other requirements will also apply;
- tissue and cell products regulated in the US as devices (e.g. requiring PMA), although much of the text will be broadly applicable to the cellular component, other requirements will also apply;
- genetically modified cell or tissues products, although the text will still be applicable to the cellular component other requirements will also apply; but for clarity, their relationship to the overall process map is included where useful