Tagged with Regulation,

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…

Mexico The lowest spender on healthcare as a percentage of GDP in mainland Latin America. A complex and fragmented reimbursement system. Clinical trial approval delays stretching across eight months. One could be forgiven for thinking that attempting to bring innovative medicines to Mexico is a thankless task. Yet, as several country…

Global AstraZeneca’s Anna Litsiou, Carolyn Hynes and Allison Guy, contributing to the September 2024 edition of DIA’s Global Forum magazine, discuss the importance of improving interactions between health technology assessment (HTA) bodies and regulatory authorities.   The need to optimize drug development and facilitate faster access for patients has focused discussions…

Hong Kong Since we last covered Hong Kong in Summer 2023, the territory’s regulatory landscape has taken a major step towards its long-term goal of establishing a full regulatory authority. Having previously required approvals from two separate regulatory authorities in other countries or regions (such as the FDA in the US, the…