Tagged with Regulation

France France’s territorial landscape is undergoing a profound shift, and departments are emerging as decisive actors in the response to medical deserts, demographic ageing and the widening gaps in prevention and mental health. In this interview, Philippe Gouet provides a rare, ground-level view of how local authorities are reshaping access to…

Taiwan Dr Chih-Kang Chiang, Director-General of the TFDA, shares how Taiwan is redefining regulation through science, transparency, and international collaboration. Combining his backgrounds in medicine, toxicology, and law, he leads efforts to strengthen patient safety, accelerate innovation in AI and regenerative medicine, and reinforce supply resilience. This conversation offers insight into…

Switzerland With the Trump administration imposing tariffs of up to 39 percent on Swiss goods (recently reduced to 15 percent), the pressure on Switzerland’s most influential industrial sector – pharmaceuticals – has undoubtedly intensified. Yet the industry continues to wield a super-size effect on the local economy, contributing up to a…

LatAm Rolf Hoenger discusses Roche LATAM’s growth, emphasising patient-centric strategies, untapped access potential, and evidence-based dialogue with policymakers. He highlights accelerated regulatory approvals, digital health initiatives, and Movement Health Foundation projects, where he serves as Vice Chair. Hoenger also underscores talent development, local leadership, and framing health as investment as essential…

LatAm Vaccination remains the most powerful public health intervention ever devised, preventing an estimated 4.4 million deaths each year, according to the WHO. Yet with misinformation spreading faster than science, and routine immunisation disrupted by pandemic aftershocks, even long-protected regions are witnessing a resurgence in preventable diseases. In Latin America, where…

Colombia Francisco Rossi, Director of Colombia’s National Food and Drug Surveillance Institute (INVIMA), discusses the agency’s ongoing transformation to become a faster, more transparent, and globally recognised regulator. Since his return in 2024, Rossi has prioritised reducing backlogs, launching the digital platform InvimÁgil, and refocusing INVIMA on public health surveillance. He…

UK Writing in the September 2025 edition of DIA’s Global Forum magazine, Janet Messer, Catherine Blewett, and Naho Yamazaki of the UK Health Research Authority (HRA) and Stephen Lam, Crina Cacou, Anthony Carter, and Sara Rajendran of the UK Medicines and Healthcare products Regulatory Agency (MHRA), lay out how UK clinical…

France Virginie Beaumeunier, head of France’s CEPS, brings deep expertise in competition law and economic regulation to pharmaceutical pricing. Her background—including roles at the Finance Inspectorate and Competition Authority—shapes her approach to balancing innovation, cost control, and industrial sovereignty. This interview highlights France’s evolving regulatory landscape, marked by a shift toward…

USA Marwan Fathallah, President and CEO of DIA, outlines how the organisation has evolved into a neutral platform bringing together regulators, industry, and academia to navigate the most pressing issues in healthcare and life sciences. From the transformative potential of AI to the realities of drug pricing, onshoring, and global competition,…

USA Richard Pazdur, MD, Director of the Oncology Centre of Excellence (OCE) at the US Food and Drug Administration (FDA), leads the agency’s efforts to streamline and modernize the regulation of cancer therapies. Since its creation in 2017, the OCE has become a hub for innovation, fostering collaboration across FDA centres,…

Europe Advanced Therapy Medicinal Products (ATMPs) – encompassing gene therapies, somatic-cell therapies, and tissue-engineered products – have been regulated in the European Union under a dedicated framework since 2009. As of 2025, the European Medicines Agency (EMA) has authorised close to 20 ATMPs (below), most of them gene therapies for rare…

Europe The EU’s Health Technology Assessment Regulation (HTAR), which kicked off in January 2025, has launched joint clinical assessments (JCAs) for oncology and advanced therapies; yet six months in, implementation remains rocky, communication is patchy, and the wider impact on access and innovation is still murky. Writing in DIA’s Global Forum…