Tagged with Regulation

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…

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…

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…

LatAm MSD’s Leonardo Semprun, writing in the June 2025 edition of DIA’s Global Forum magazine, reflects on some of the key lessons from the Latin America Town Hall at DIA Europe 2025. Latin America is at a pivotal moment in the evolution of its regulatory systems. Factors such as the adoption…

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…

Global 2023 may have been a breakthrough year for cell and gene therapies with the FDA approving a record of seven novel treatments, but 2024 did not fall behind in the number of greenlit therapies. With seven new approvals and three expanded indications, the cell and gene therapies authorized by the…

Saudi Arabia As Saudi Arabia continues its ambitious healthcare transformation under Vision 2030, the Ministry of Health is playing a central role in reimagining the nation’s approach to health and wellness. Fahad bin Abdulrahman AlJalajel, His Excellency, the Minister of Health, outlines key milestones in the shift toward a value-based healthcare system,…

China 2024 was another groundbreaking year for Chinese medicine approvals. Writing in the March 2025 edition of DIA’s Global Forum magazine, Juan Valencia S. and Angel Shao of PharmCube explain how and why.   Driven by drugmakers’ growing interest in accessing the world’s second-largest pharmaceutical market, China has recently seen a…

Saudi Arabia Dr Vineta Bhalla, Partner and Chief Medical Officer at Deloitte Middle East, brings a wealth of experience from her background as a clinician, public health expert, and healthcare leader in both Singapore and the UK. Bhalla shares her insights into Saudi Arabia’s healthcare transformation, highlighting the Kingdom’s methodical approach to…