Table 1.

Summary table.

	Description	Distinguishing features	“GMP” inspections	International relevance
Canada (Health Canada)	Cell therapy products (CTPs) are considered drugs that must follow Good Manufacturing Practice (GMP) requirements Flexible risk-based approach is taken (i.e., accommodations to GMP may be made, as required, by the technology) More stringent GMP approach throughout clinical trial phases	Establishment license not strictly required for any phase of clinical trials, although strategically necessary by phase 3	Reviewed by Biologics and Genetic Therapies Directorate (pre-market review group) under Division 5—Clinical Trial Application for all phases of clinical trials	No explicit evidence for meeting GMP is provided by Health Canada Implicit evidence of meeting GMP standards is provided in a clinical trial “No Objection Letter”
United States (FDA)	CTPs are considered drugs that must follow GMP and GTP requirements FDA relies on pre-market regulatory professionals to assess phase 1 products for clinical trials during Investigational New Drug (IND) submission reviews, while CT products for phase 2 and 3 require a manufacturing site registration	Establishment license required to manufacture phase 2 and 3 clinical trial products	Phase 1 clinical trial products reviewed under IND submissions by CBER (FDA) Establishment registered with FDA, listed on DECRS	An establishment registration from US FDA indicates GMP compliance for phase 2 or 3 studies (but not phase 1) This strongly supports Health Canada or EMA submissions
European Union (EMA)	Requirements for advanced therapy medicinal products well established, most defined out of the three ICH member jurisdictions under comparison	Manufacturing authorization required for all stages of clinical trial development	Inspections by a competent authority/qualified person (QP) of a member state	A QP site declaration indicates the site complies with EU GMP for all phases of study This strongly supports Health Canada or US FDA submissions