Japan's Conditional/Time-Limited Early Approval System in Regenerative Medicine: A Case Study of Rise and Falls of Autologous Skeletal Myoblast Sheets.

Japan's conditional/time-limited early approval program, initiated in 2014, aimed to advance regenerative medicine by expediting market access. However, the withdrawal of autologous skeletal myoblast sheets (Heartsheet) due to ineffectiveness raises concerns about the balance between rapid approval and scientific integrity. While the program seeks to boost innovation, it risks endorsing costly, unclear treatments under national health care.

Addressing Vaccine Hesitancy and misinformation amidst Japan's self-amplifying mRNA COVID-19 Vaccine Rollout.

As of October 1, 2024, Japan implemented a revised COVID-19 vaccination strategy, shifting from a fully publicly funded model to one where costs are partially or fully borne by recipients. This new annual program targets individuals aged 65 and above, and those aged 60-64 at higher risk of severe illness, requiring them to cover some vaccination expenses. For others, the vaccine remains voluntary and self-funded.

Continued cancer drug approvals in Japan and Europe after market withdrawal in the United States: A comparative study of accelerated approvals.

Regulatory authorities must balance ensuring evidence of efficacy and safety of new drugs. Various regulatory pathways, such as the accelerated approval program in the United States (US), allow authorities to quickly approve drugs for severely ill patients by granting market authorization based on surrogate end points and pending confirmatory trials. In this cross-sectional study, we considered 23 indications of cancer drugs that received accelerated approval by the US Food and Drug Administration (FDA) but were subsequently withdrawn as of April 2023.