Tagged with Regulation,

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…

Mexico Pharmaceutical innovators are sounding the alarm on Mexico’s healthcare reforms, despite the government’s bold claims. At industry group AMIIF’s 75th anniversary, Health Secretary David Kershenobich hailed the Sheinbaum administration’s investments and regulatory shake‑up as game-changing. But pharma leaders argue that real-world access remains elusive, with one industry veteran warning it…

Africa Writing in the July 2025 edition of DIA’s Global Forum magazine, Alex Juma Ismail of the African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD) and Vicki Gold, a consultant to the Gates Foundation, unveil the “Continental List of Human Medicinal Products” pilot—a first-of-its-kind initiative led by the…

Denmark As Denmark sets its sights on becoming a global leader in life sciences by 2030, Morten Bødskov, Minister for Industry, Business, and Financial Affairs, outlines the strategic pillars of the country’s Life Science Strategy Toward 2030. With an unwavering commitment to strengthening Denmark’s competitive edge in the face of fierce…

Europe Lora Fleifel, Director of Global Value Access & Pricing Operations Europe for Oncology at Merck, dissects the promise and pitfalls of the new EU Joint Clinical Assessment (JCA). The JCA aims to harmonise clinical evaluations to help reduce the significant disparities in patient access to innovative treatments that still exist…

Denmark With a mandate spanning pharmaceuticals, medical devices, and clinical research, the Danish Medicines Agency plays a central role in shaping both national health policy and European regulatory alignment. Under the leadership of Nils Falk Bjerregaard, the agency is navigating a period of accelerated transformation, defined by digitalisation, real-world evidence, decentralised…