Japan
Japan's regulatory authorities recommend approval of products including a cell therapy, while setting reimbursement prices of newly approved drugs and cutting some others following cost-effectiveness assessment.
Daiichi Sankyo’s MMR Vaccine, Ultragenux’s triheptanoin also won approval recommendations.
Clinigen's CEO and senior executives outline how the services company navigated Japan’s rigorous regulatory framework to secure approval for Prolacta’s human milk–based fortifier as a prescription biological product.
Idvynso, Merck & Co.'s oral once-daily combination of doravirine and Japan-originated molecule islatravir, has been granted its global-first approval in Japan, ahead of the US.
Japan's regulatory authorities are implementing a number of updates and revisions to the national drug law in measures designed to address shortages of high-demand products and clarify guidance in areas including conditional approvals.
Japan's drug regulatory agency is rolling out a new system of priority consultations for smaller companies with no presence in the country to support the more timely commercialization of high-need new drugs.
Japan has granted the first positive approval recommendations worldwide for two allogenic cell therapies derived from induced pluripotent stem cells, Sumitomo’s raguneprocel for Parkinson’s and Cuorips’ cardiomyocyte patches for heart failure.
Elevidys granted reimbursement in Japan following its conditional approval at almost $2m per patient, a price local regulators note is still lower than levels in the US.
Japan is gearing up for a Lower House election in February and the result could affect biopharma policies. Multiple political parties have laid out reform plans in the area should they win.
Late 2025 saw a flurry of policy moves in Japan ahead of this April's regular drug reimbursement price revision, with pharma industry groups decrying a related medical fee increase. But other positive changes are set to be implemented.
The JPY330bn package bundles existing and new support funds for the biopharma industry, with the national government recognizing its importance for both national security and economic growth.
Several global products have been granted approval recommendations in Japan, while two Japan-originated drugs received a preliminary nod in their home country after being approved first elsewhere through licensees.
While Japan tries to balance its healthcare costs, the major US industry group is concerned reimbursement pricing practices in the country could influence US levels under Trump's MFN policy.
Excellence, innovation and deal-making across the Japanese biopharma sector were celebrated at the Citeline Japan Awards 2025, held in Tokyo on 21 October.
After tough negotiations which won the country a lower US levy on pharmaceuticals, there still appears to be some confusion within the Japanese government following President Trump's latest announcement on global pharma tariffs.
Shortlists of potential winners in all categories of the Citeline Japan Awards 2025 have now been released. Join us at the event in Tokyo on October 21, it’s not too late to book your table!
Japan's government has already allocated more than $400m to repatriate manufacturing of important drugs and continues to provide support as it expands a list of "national security" drugs.
An executive order has given the go-ahead for US tariffs on Japan to be amended to “zero percent” for generics, just weeks after the EU revealed an effective exemption from its own US tariffs. Meanwhile, a separate order suggests that generics could enjoy broader global exemptions from tariffs.
Along with multiple new therapeutics for NSCLC, Astellas's Izervay and several products licensed from US companies receive approval recommendations in Japan.
While Japanese government announces 8-15% price cuts for four drugs, including Leqembi, industry groups urge operational improvements to national cost effectiveness assessment scheme.