Tagged with Regulation

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,…

USA The FDA’s Sarah Yim discusses the evolving regulatory landscape for biosimilars in the US, the shift toward analytical-heavy reviews over large clinical studies, the legislative push to simplify interchangeability, and the agency’s commitment to increasing market competition and patient access through streamlined development pathways. My goal, and the FDA goal…

Hong Kong Hong Kong is at a strategic inflection point as it seeks to redefine its role in global life sciences through regulatory credibility, institutional design, and long-term positioning between China and international markets. Industry stalwart Lo Yuk Lam reflects on how regulation, talent, capital markets, and national planning intersect to shape…

USA David Barrett has led the American Society of Gene & Cell Therapy (ASGCT) since 2018, guiding its evolution into the leading professional body for scientists, clinicians, industry leaders and patient advocates in cell and gene therapy. Founded in 1996, ASGCT now sits at the centre of research, education and policy…

USA Patients and carers with lived experience of a disease have valuable insights to share with physicians and drug developers alike. This is especially true of rare diseases, defined in the US as those that affect fewer than 200,000 people nationwide and which collectively impact over 30 million Americans. For these…

USA As rare disease science accelerates, regulators face growing pressure to adapt without compromising rigour. In this interview, Amy Comstock Rick explains how the FDA Rare Disease Innovation Hub is strengthening cross-centre coordination, evolving evidence expectations for ultra-rare conditions, and creating new spaces for dialogue between regulators, developers, and patients. The…

Africa African healthcare and pharma are moving from ambition to action. Regular PharmaBoardroom contributor Lenias Hwenda explains how, after years of over-dependence on global supply chains, fragmented regulation, and limited local manufacturing, the continent is asserting greater control over its health destiny. Regulatory maturity is rising. Patient safety is gaining prominence,…

USA Writing in the January 2026 edition of DIA Global Forum, Mariana Socal and Antonio J. Trujillo from the Johns Hopkins Bloomberg School of Public Health and Rachel Goode of Fresenius Kabi argue  that biosimilars could significantly reduce US drug spending and expand patient access, but that their impact is being…

Europe Writing in the January 2026 edition of DIA’s Global Forum, Samantha Holmes and Fiona Adshead of the Sustainable Healthcare Coalition argue that climate change is already reshaping healthcare and the medicines life cycle, while the pharma sector itself contributes materially to global emissions. Against this backdrop, the European Medicines Agency…

LatAm From cancer treatments to cardiovascular drugs, access to innovative medicines in South America lags behind developed market norms with patients forced to endure considerable delays for therapies that are already considered global standards. According to the Waiting to Access Innovative Therapies (W.A.I.T.) Indicator from FIFARMA, an association representing research-based pharma…

France ANSM’s Director General Catherine Paugam-Burtz offers a clear view of how France’s medicines agency is adapting to a fast-shifting landscape. She discusses ANSM’s role within the European regulatory system, the agency’s digital transformation, the pressure to accelerate clinical research, the importance of early access, and the work underway to strengthen…