USA As cell and gene therapies move closer to broader clinical reality, questions around manufacturing, scalability, and regulatory flexibility are becoming just as important as the science itself. Denise Gavin and Steven Oh of the FDA’s Office of Therapeutic Products discuss how the agency is adapting its chemistry, manufacturing, and controls…
Europe Against a backdrop of rising geopolitical tension, regulatory fragmentation, and mounting pressure on Europe’s healthcare systems, Prague-headquartered Zentiva is positioning itself as a distinctly European pharmaceutical player focused on long-term resilience, affordability, and supply security. CEO Steffen Saltofte reflects on the company’s transformation since its carve out from Sanofi, its…
USA The US Food and Drug Administration (FDA) finds itself in the midst of unprecedented political turmoil. The Trump Administration’s Department of Government Efficiency (DOGE) removed 3,500 of the Agency’s 20,000 employees in 2025, and a relentless succession of leadership upheavals has compounded the disruption. After 17 months of regulatory and…
USA Vijay Kumar is the acting director of the Office of Therapeutic Products (OTP) within the FDA’s Center for Biologics Evaluation and Research (CBER), the regulatory super office established in 2023 to oversee the rapidly expanding cell and gene therapy landscape. With a mandate spanning gene therapies, stem cell and cell-derived…
Hong Kong When, in his 2023 policy address, Hong Kong Chief Executive John Lee announced the territory’s intention to conduct its own primary reviews of medicines, the initial industry reaction was mixed. The legitimate questions of what this updated regulator would do, and whom it would serve, swirled, with many Western multinationals…
Hong Kong After a rocky couple of years, Hong Kong has defied its sceptics and definitively bounced back. As Asia’s financial capital and the bridge between mainland China and international markets, the global stock market slump between 2021 and 2024 had an outsized impact on Hong Kong, with sluggish GDP growth and…
Australia Medicines regulatory agencies face enormous challenges in supporting and maintaining the safety, quality and supply of therapeutic goods in their respective countries and regions. Professor Anthony (Tony) Lawler, head of Australia’s Therapeutic Goods Administration (TGA), took time out from this work to respond to questions regarding the progress that TGA is…
Taiwan Jaw-Jou Kang, Professor at NYCU, former head of Taiwan’s Food and Drug Administration and current chair of the Taiwan Society of Regulatory Affairs for Medicinal Products discusses the nation’s regulatory transformation, challenges in talent retention, advances in regenerative medicine frameworks, and Taiwan’s positioning within the global biopharmaceutical ecosystem whilst navigating…
Taiwan Steve Kuo, Chairman of TRPMA, outlines Taiwan’s biotech strategy: strengthening clinical trial infrastructure, regulatory alignment and global partnerships. Drawing on experience across academia, government and diplomacy, he emphasises cultural change in trial participation and building a collaborative ecosystem, positioning Taiwan to compete globally, particularly in cell therapy and innovative drug…
USA Just over one year into the second Trump administration, the US healthcare and life science market is navigating a steady stream of series of unprecedented policy shifts. Long defined by patients in the US having more innovative medicines available to them than anywhere else on earth, but the market’s long-criticized…
USA Paul Kim, a leading FDA attorney and policy expert formerly at both the FDA and the US Congress, discusses the current shifts within the American life sciences and regulatory landscape. Kim examines the prevailing sentiment of the industry amidst a period of significant structural upheaval and regulatory whiplash. He offers…
Hong Kong Sabrina Chan, Senior Executive at HKAPI, highlights progress in Hong Kong’s biomedical ambitions, including establishing an independent regulator, expanding clinical trial capacity via the Greater Bay Area Clinical Trial Institute (GBAICTI), and leveraging 34 years of real-world health data. She underscores efforts to enhance primary healthcare, support rare disease access,…
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