Table 5.

The comparison between guideline documents and product assessments.

Guidance documents/products	Pharmacology				Toxicology
	Pharmacodynamics	Biodistribution/Pharmacokinetics	Mechanical property	Validation of clinical evaluation	Local toxicity	Systemic toxicity	Tumorigenicity	Genotoxicity
Guideline of the EU	✔a	✔	✔	✔	✔	✔	✔	✔
Guideline of the US	✔	✔	✔	✔	✔	✔	✔	–
Guideline of Japan	✔	✔	✔	–	✔	✔	✔	–
Carticel®	✔	✔	–	–	✔	–	–	–
ChondroCelect™	✔	✔	–	–	✔	✔	✔	–
JACC	✔	–b	–	–	✔	✔	✔	✔
MACI®	✔	✔	✔	✔	✔	✔	–	✔

EU, European Union; US, United States; JP, Japan.

^a✔: Described.

^b–: Not described.