Tagged with Regulation,

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…

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…

Europe The EMA’s Pre-Accession Assistance Program (IPA) helps EU candidate and potential candidate countries align their medicines regulations with EU standards through training, capacity-building, and policy support. As a new op-ed in the February 2025 edition of DIA’s Global Forum magazine outlines, an impact assessment of IPA II (2020-2023) showed significant…

India Shagun Sharma, Vipul Kumar Gupta, and Helene Sou of Takeda, writing in the December 2024 edition of DIA’s Global Forum magazine, look at how updates to India’s regulatory framework for pharmaceuticals are impacting the industry.   Since 2001, the regulatory environment for clinical research and drug development in India has…

Singapore Writing in the November 2024 edition of DIA’s Global Forum magazine, Johnson & Johnson’s Sandy Chan looks at the fast-evolving regulatory framework for medicines in the dynamic Asia-Pacific region.   Asia Pacific (AP) is an immensely diverse and dynamic region with varying regulatory capabilities and capacities; consequently, AP regulators and…

Switzerland Raimund Bruhin discusses Swissmedic’s participation in cross-border regulatory initiatives such as the Access Consortium and Orbis and its efforts to support the Global South in developing regulatory standards. Bruhin also addresses the regulatory challenges posed by new technologies, such as Advanced Therapy Medicinal Products (ATMP), and Swissmedic’s strategic objectives, especially…

USA In a country characterised by its racial and ethnic diversity, but where less than 5 percent of clinical trial data includes racial and ethnic factors, clinical trial diversity has become a key issue for the US FDA. Drug and medical device makers recognise the importance of diversity but find their…