China Chinese biotechs are now outpacing multinationals at getting drugs into pivotal trials — but MNCs still win the race to final approval. In this piece from the September 2026 edition of DIA Global Forum, Li Wang of Lilly’s China Drug Development & Medical Affairs Center digs into fresh 2023–2025 timeline…
Singapore Singapore’s Health Sciences Authority has become one of the world’s most respected drug regulators, earning WHO maturity level 4 status and a seat at tables like the Access Consortium and Project Orbis. Writing in the September 2026 edition of DIA Global Forum, Sandy Chan, Sok Bee Lim, Shirley Yong, and…
Europe The European Union is in the midst of the biggest shake-up of its pharmaceutical rulebook in a generation, racing to secure supply chains, speed up drug development, and keep Europe competitive against the US and Asia; all without loosening the safety net patients rely on. Sandra Gallina, Director-General for Health…
China Chinese pharmaceutical companies are increasingly seeking drug approval in the EU, US, and Australia, beyond the NMPA. Daphne Smyth of Veristat has witnessed this shift firsthand, advising sponsors on data gaps, supplementary studies, and the regulatory quirks that stand in the way of a drug developed in China gaining marketing…
USA Neuroscience is back. After a litany of divestments and scale backs in the 2010s, diseases of the brain are now the second-most-funded area in biotech, behind only cancer. However, this remains a complex and challenging field, leading neuroscience biotechs – three of which are profiled below – to develop very…
Africa Can a medicine be considered “available” if it can’t be trusted? As Africa’s manufacturing base expands and its regulatory systems mature, that question is moving to the centre of the continent’s health agenda. Lenias Hwenda maps out why 2026 is a turning point for African patient safety — anchored by…
MEA Once regarded as a strategic afterthought by international biopharma, the Middle East has undergone a profound transformation in recent years, emerging as an early adopter of next-generation therapies for rare diseases. Regional regulatory authorities are accelerating approval timelines, reflecting an aggressive institutional ambition to secure speedy access to cutting-edge medical…
Europe Strong patent portfolios can create substantial commercial value for biopharma companies. As Isobel Barry, partner at life sciences-focused IP firm Carpmaels & Ransford LLP explains, opportunities to patent new small molecule, biologics and complex therapeutics arise throughout the go-to-market process, from early-stage research, through formulation development and clinical trials, up…
Taiwan Semiconductors: Silicon Powerhouse Taiwan and semiconductors – the microscopic chips inside virtually every electronic device – are inextricably linked. For a modestly sized island, Taiwan’s semiconductor dominance is extraordinary: through the state-backed TSMC (Taiwan Semiconductor Manufacturing Company), the island functions as the world’s foundry, manufacturing the advanced chips designed by…
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 Germany’s Medical Research Act is almost two years old. Writing in the June/July 2026 edition of DIA Global Forum, Thomas Sudhop, Claudia Riedel and Karl Broich of the Federal Institute for Drugs and Medical Devices (BfArM) outline how the Act attempts to revitalise clinical research in Germany, balancing faster procedures…
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…
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