Table 6.

The parameters of PMS for CGTPs in the EU, the US, Japan, South Korea, and China

Framework	the EU	the US	Japan	South Korea	China
Main guidelines for the PMS of CGTPs	1) Guideline on safety and efficacy follow-up-risk management of advanced therapy medicinal products 2) Guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products draft	1) Guidance for industry: post-marketing studies and clinical trials —implementation of Sect. 505(o)(3) of the Federal Food, Drug, and Cosmetic Act 2) REMS: FDA’s application of statutory factors in determining when a REMS is necessary 3) Guidance for industry long term follow-up after administration of human gene therapy products guidance for industry	Risk management plan guidance Procedures for developing post-marketing study plan	Guideline on re-examination affairs of new drugs etc	1) Technical guidelines for long-term follow-up clinical studies of gene products 2) Technical guidelines for clinical risk management plan of chimeric antigen receptor T cell (CAR-T) therapeutic products 3) Guidance for writing a clinical risk management plan (for Trial Implementation) 4) Guideline for pharmacovigilance examination
Tools for PMS	RMP PSMF PSUR	REMS Reporting of adverse reactions Product labeling PMR and PMC PSUR	RMP GVP Good post-marketing study practice PSUR	RMP GMP inspection Product license renewal PSUR	RMP PV system PSUR
Submission of PSUR	Every 6 months for the first 2 years after initial marketing, once a year for the next 2 years, and every 3 years thereafter	Every quarter within 3 years after drug approval, and once a year thereafter	Every 6 months for the first 2 years after the drug is initially marketed, and once a year thereafter	Every 6 months in the first 2 years from the approval date, once a year thereafter, and the final report should be submitted within 2 months after the expiration of the surveillance period	Once a year before first re-registration, and once every 5 years thereafter
Mandatory PV requirements	Routine and additional PV activities Routine and additional RMM Serious ADR reports	Adverse event monitoring Routine and additional PV PMR Spontaneous reports	Routine and additional PV activities Routine and additional risk minimization activities Re-examination Reporting of adverse drug reactions	Re-examination Re-evaluation	Routine PVP Mandatory additional PVP Routine RMM
Optional PV requirements	Voluntary PV activities (i.e., voluntary PASS)	PMC Risk minimization action plan	Voluntary surveillance and studies	Spontaneous ADR monitoring	Voluntary additional PVP Spontaneous ADR reporting