Tagged with Medicines

Denmark Since stepping into the role of Chair of the Danish Medicines Council in early 2025, Birgitte Klindt Poulsen has been navigating the delicate balance between accelerating patient access to innovation and maintaining the rigour of independent, evidence-based evaluation. In this interview, she shares how the Council is adapting to a…

Denmark As Denmark launches its ambitious Life Science Strategy 2030, the Danish Medicines Agency (DKMA), long held as the embodiment of European regulatory excellence, is fine-tuning its priorities. New director Nils Falk Bjerregaard sees the DKMA’s role as a “facilitator of innovation,” supporting early-stage development and leveraging real-world data at home,…

Europe Will a new ‘Critical Medicines Act’ go far enough to ensure Europe’s resilience to future health crises?   A Continent at Risk The COVID-19 pandemic exposed serious vulnerabilities in the European medicine supply chain. EU countries suddenly found themselves competing for limited supplies of sedatives and antibiotics for ICU care,…

Europe European pharma is at a turning point, with rising cost pressures, regulatory shifts, and supply chain vulnerabilities reshaping the industry. As the new president of Medicines for Europe, STADA’s Stephan Eder is now at the forefront of driving the change that Europe needs. In this new role as head of…

Africa Building on the recent controversy over Tanzania’s handling of a suspected Marburg virus outbreak, Medicines for Africa’s Lenias Hwenda explores how African nations often face disproportionate consequences for outbreak transparency—penalties that wealthier countries rarely experience.   African countries face a difficult choice during outbreak situations. On one hand, they have…

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…

Global In 2024, people living with HIV have more, and more varied, access to HIV prevention and treatment options than ever before. Thanks to global activism efforts forcing pharma to step up, and the establishment of some vital institutional structures in the first decade of the millennium, access is up, while…

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…

Europe The EMA’s Peter Arlett looks back on two years of the Accelerating Clinical Trials in the European Union (ACT EU) initiative which aims to improve the environment for clinical trials in the EU by transforming how trials are initiated, designed, and run. In conversation following DIA Europe 2024 in Brussels,…

Europe PharmaBoardroom was delighted to attend DIA Europe 2024 in Brussels earlier this month, bringing together a veritable who’s-who of the European and global regulatory community. The politicians, regulators, payers, patient advocates, industry representatives, and service providers in attendance were treated to a three-day buffet of engaging panels and townhalls with…

Europe The European Medicines Agency (EMA) recommended 77 drugs for marketing authorisation in 2023, including 39 new active substances, coming up behind the FDA’s record 55 new drug approvals last year. Cancer led the roster of EMA green lights with 25 authorisations, including nine therapies the agency has discerned as major…