Tagged with Regulation

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…

Europe Contributing to the August 2024 edition of DIA’s Global Forum magazine, Magda Chlebus from the EFPIA, Steffen Thirstrup and Alberto Ganan Jimenez from the EMA, Katharina Nothelfer of AiCuris Anti-infective Cures, Pedro Franco of Merck Serono, Annette Bakker of CTF Europe, Tim Chesworth of AstraZeneca, Jeevan Virk of Novartis, Virginie…

Global DIA’s Sorcha McCrohan, contributing to the the August 2024 edition of DIA’s Global Forum magazine, reviews insights from the town hall meetings that brought together regulators from around the world at the organization’s Global Annual Meeting 2024.   Regulators worldwide recently convened in San Diego for DIA’s Global Annual Meeting 2024 to…

China Writing in the July 2024 edition of DIA’s Global Forum magazine Mingcan DU and Fengyun (Vicky) HAN of Johnson & Johnson Global Regulatory Policy and Intelligence look back at the evolution of the use of real-world evidence (RWE) in regulatory decision-making in China, including key use cases and future prospects.…

Africa The IFPMA’s Sarah Adam, writing in the July 2024 edition of DIA’s Global Forum magazine, looks back on an insightful discussion on the progress towards an African Medicines Agency at the DIA Europe conference earlier this year. The African Medicines Agency (AMA) is paving the way for Africa to achieve…

Europe Writing in DIA’s Global Forum magazine for June 2024, the organization’s Vedran Raguz reviews some of the key takeaways from DIA Europe 2024, namely the need for increased collaboration, alignment and harmonization among international regulatory bodies and stakeholders.   One of the overarching themes of DIA Europe 2024 was the imperative of…

LatAm For the second consecutive year, DIA Europe hosted a Latin America Town Hall, a panel discussion to foster collaboration and share updates from regulatory activities in Latin America and Europe, and the intersections between them. MSD’s Leonardo Semprun, writing in the May 2024 edition of DIA’s Global Forum magazine, highlights…

Global 2023 was a breakthrough year for cell and gene therapies. The field saw a record number of FDA approvals, as other promising therapies in a broad range of therapeutic areas progressed through the pipeline. 2024 looks to be another important year with up to 17 new therapies poised for regulatory…