Tagged with Regulator

Switzerland 2024 marked a transformative year for Switzerland’s regulatory authority, Swissmedic. As part of its ambitious 2023–2026 strategy, the agency made significant strides towards digital transformation and improving access to innovative medicines while delivering a notable 12 percent increase in new drug approvals with 46 new active substances. Drive for Digital…

Japan Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) concluded FY 2024‑25 (April 2024–March 2025) with a total of 148 approval decisions, including no less than 66 new active ingredients and 82 lifecycle updates, including new indications, pediatric expansions, and formulation changes. Innovation Snapshot A steady stream of orphan and rare‑disease designations—including sparsentan for primary…

Global Whether in the corridors of the FDA or the fast-evolving frameworks of ANVISA in Brazil, regulators around the world are undergoing a quiet revolution. While mature markets like the US and Europe double down on digitalisation and real-world evidence, emerging players like Brazil and China are accelerating access and joining…

Brazil Dr. Rodrigues Mota brings two decades of leadership experience within ANVISA, the Brazilian Health Regulatory Authority, where he has held multiple senior positions and now serves as a key architect of the organisation’s strategic transformation. His tenure spans critical periods of regulatory modernisation, digital transformation, and international collaboration, positioning him…

Europe As China and the US attract an increasing share of commercial clinical trials, Europe is fighting to reclaim its spot as a global research leader. While Europe has world-class hospitals and experienced regulators, it has struggled with a complicated and fragmented approval system that has pushed trial sponsors elsewhere. To…

Denmark Helle Harder positions the Danish National Research Ethics Centre as a model for strategic regulatory innovation, aiming to boost Europe’s clinical trial competitiveness. By advancing AI integration, risk-based assessments, and cross-border harmonisation, Denmark is redefining ethical oversight. The Centre’s leadership articulates a compelling vision where regulatory excellence becomes a catalyst…

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,…

UK A roundup of the biggest UK pharma news, including the industry’s uncertain position after the UK-US trade accord; Haleon’s full takeover of its Chinese joint venture; AstraZeneca’s acquisition of Belgian biotech EsoBiotec and its exit from neuroscience; GSK’s liver disease asset deal with Boston Pharmaceuticals, and CellCentric’s US expansion.  …

Switzerland Switzerland has long been recognised as a centre of scientific excellence, and in the field of Advanced Therapy Medicinal Products (ATMPs), it is quickly becoming a regulatory trailblazer. In this in-depth conversation, Julia Djonova, Head of ATMPs at Swissmedic, shares how the agency is positioning itself at the forefront of…

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…

Americas Diego Salas from the Latin American Federation of the Pharmaceutical Industry (FIFARMA) and Carlos Felipe Escobar Roa from the Instituto de Prospectiva e Innovacion en Salud (INNOS), writing in the May 2025 edition of DIA’s Global Forum magazine, discuss the findings of a pioneering report launched at the end of…