Japan We have evolved well beyond the traditional CRO model Global biopharma companies are looking at Japan through a different lens, seeking partners that can navigate an increasingly complex regulatory landscape while supporting integrated development across Asia. At the heart of that evolution is CMIC, whose President and Representative Executive Officer,…
Europe As the European Medicines Agency navigates the most significant expansion of its mandate in a generation, Executive Director Emer Cooke highlights how the regulator is further strengthening its role across the full lifecycle of medicines. Cooke sets out how EMA is enhancing its engagement from early developer support and clinical…
Germany Professor Stefan Vieths, president of Germany’s Paul-Ehrlich-Institut (PEI), explains how Europe’s most specialised biomedicines regulator is navigating a period of rapid transformation. Vieths traces the PEI’s 130-year evolution from a serum-testing institute into the federal authority overseeing vaccines, blood products, and advanced therapies; examines how Germany’s Medical Research Act is…
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…
China Writing in the March 2026 edition of DIA’s Global Forum magazine, PharmCube’s Juan Valencia looks back on a record year for drug approvals in China, and what it means for the future of access and innovation in the world’s second largest market. With the tremendous development of China’s innovative…
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…
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…
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…
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…
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,…
Switzerland 2024 marked a transformative year for Switzerland’s regulatory authority, Swissmedic. As part of its ambitious 2023–2026 strategy, the agency made significant strides towards digital transformation and improving access to innovative medicines while delivering a notable 12 percent increase in new drug approvals with 46 new active substances. Drive for Digital…
Japan Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) concluded FY 2024‑25 (April 2024–March 2025) with a total of 148 approval decisions, including no less than 66 new active ingredients and 82 lifecycle updates, including new indications, pediatric expansions, and formulation changes. Innovation Snapshot A steady stream of orphan and rare‑disease designations—including sparsentan for primary…
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