Japan’s Conditional Approval System Passes Test With Global First Lorlatinib Nod
Pfizer’s ALK inhibitor gets its first marketing clearance globally as a second-line indication, showing Japan's so far untested scheme is working as it should to enable early access.
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Despite the emergence of the coronavirus pandemic at the end of the period, Japan’s regulatory authorities maintained an annual pace of new drug approvals on a par with the previous year, with expedited programs helping several drugs to market.
Oncology, Orphans Dominate Japan Fiscal 2018 Approvals
Oncology again dominated new drug approvals in Japan last fiscal year, when expedited and special review pathways also played a major role in ensuring early access to new therapies.
Japan Price Reforms - Major Takeaways
Japan's complex reimbursement pricing system was further tweaked in April in a bid to raise the bar for innovation while controlling costs. What are the main changes and is industry happy?