Regulatory fast-track supports global approvals, McKinsey saysJapan recorded 24 US Food and Drug Administration novel-drug approvals between 2015 and 2023, the highest total among Asian markets, according to McKinsey & Company. Japan’s biopharma sector operates across the full value chain, from discovery through commercialisation, enabling the development of launch-ready assets for global markets, according to McKinsey. Regulatory frameworks underpin this positioning, with the Ministry of Health, Labour, and Welfare’s Sakigake designation streamlining priority drug reviews and accelerating time to market, McKinsey said. Japan has also introduced a conditional, time-limited approval pathway for regenerative medicine, supporting earlier clinical application of cell and gene therapies whilst remaining aligned with global regulatory standards. The consultancy added that one in four leaders at Japan’s leading pharmaceutical companies has international work experience, strengthening the country’s position as Asia’s most globally integrated biopharma partner.