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…

USA The Promising Pathways Act 2.0 is a newly proposed bill that aims to expedite and streamline approval pathways for rare disease therapies in the US. The Act is, however, facing a number of challenges in terms of implementation. The sponsors of these niche therapies tend to be small and medium-sized…

Global Brendan Shaw paints a concerning picture of global health priorities post-pandemic, highlighting the need for renewed focus and investment in healthcare systems to prevent further backsliding.   “There isn’t a financing gap. There is just money that is not moving towards the right things. There’s plenty of money out there”…

China Writing exclusively for PharmaBoardroom, Song Ruilin of the China Pharmaceutical Innovation and Research Development Association (PhIRDA) outlines some of the key improvements and optimisations in the regulatory landscape for pharmaceutical innovation in China. Professor Song also notes the major impact that Chinese innovation is having on global R&D pipelines and…

Global Writing in the June 2024 edition of ISPOR’s Value in Health journal, Nancy J. Devlin, PhD, Michael F. Drummond, MCom, DPhil, and C. Daniel Mullins, PhD look back on the history of QALYs in cost-effectiveness analysis and policy decision making, and why the backlash against QALYs in the United States…

Japan Writing in DIA’s Global Forum magazine for June 2024, Mamoru Narukawa of Kitasato University Graduate School of Pharmaceutical Sciences takes a look at some of the positive trends impacting Japan’s drug pricing system.   Drug expenditure as a percentage of healthcare costs in Japan has been stable at approximately 22% in…

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…

Global Marijn Verhoef, Director of Operations and Research at the Access to Medicine Foundation examines the interconnected challenges of drug shortages and antimicrobial resistance. Verhoef urges decisive and urgent action from the pharma companies that manufacture lifesaving antibiotics and antifungals to ensure that patients can get the right medicine when they…

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…

Africa Medicines for Africa’s Lenias Hwenda reflects on Moderna’s recent decision not to go ahead with plans for a vaccine manufacturing facility in Kenya, and why local production remains crucial to building Africa’s healthcare autonomy.   In a turn of events that is both disappointing yet somehow not surprising, Moderna recently…

Africa Medicines for Africa’s Lenias Hwenda argues that the success of the much-talked-about African Medicines Agency hinges on a critical mass of African national regulators achieving WHO Level 3 maturity status. While acknowledging the importance of international actors in making this happen, Hwenda argues that – if the African Medicines Agency…