AABB/ISCT GTP Interpretative Tool

Human cell and tissue-based products (HCT/P) are regulated under 21 CRF 1271.10(a) and Sections 361 of the Public Health Service (PHS) Act by the Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER). HCT/Ps classified as ‘361 products’ are not regulated as biologics but must be processed according to Good Tissue Practice (GTP) in facilities subject to regulatory oversight. Cell or tissue-based products that do not comply with all requirements to be considered solely regulated under 21 CFR 1271 as “361” products then all CGMP requirements apply as a “351” product. As described in the Guidance for Industry, products regulated under Section 361 require no premarket regulatory review, approval, or clearance when all criteria under 21 CFR 1271.10(a) are met, which include:

• HCT/P is minimally manipulated;
• HCT/P is intended for homologous use only;
• No other cells or tissues are used in combination to manufacture the HCT/P; and may include one or more of the following;
• The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for function;
  OR
• The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for function; and
  • Is intended for autologous use; or
  • Allogeneic use in a first- or second-degree relative; or Reproductive use.

To understand more about these regulations, an interpretative tool which associates the GTP regulations with guidance references, considerations, and additional resources was created by a team of industry leaders with expertise in cell- and tissue-based product development and manufacturing.

The formation of the team is the result of a collaboration between the Association for the Advancement of Blood & Biotherapies (AABB) and International Society for Cell & Gene Therapy (ISCT) who develop projects of mutual interest in a joint AABB-ISCT workgroup (WG).

The GTP tool includes references to GTP regulations, GTP Guidance references, GTP considerations and additional resources. Links are provided without interpretation and are not intended as a substitute for information on the terms and procedures directly associated with regulatory requirements governing 361-based products. Links and references will be reviewed periodically and updated accordingly.

AABB/ISCT GTP Interpretative Tool