Tagged with Regulator

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…

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…

USA Peter Marks, the US FDA’s top official for vaccines and cell and gene therapies, has resigned. A survivor of the first Trump administration, when his office faced intense pressure to fast-track COVID vaccine approvals, Marks reportedly clashed with new Health and Human Services Secretary Robert F. Kennedy Jr. and his…

Pharma Legal Handbook Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? In Japan, it is important whether a drug or medical device is covered by the NHI (i.e., whether it is listed on the NHI Price List). If it is, the product is eligible for NHI…

Pharma Legal Handbook Are there any Managed entry agreements in place in your country? (If so, please list them) No.   For each Individual Managed entry Agreement Describe the fundamentals of the Managed entry Agreement, its rationale and the process for implementing it. N/A   When should this Managed Entry Agreement be considered?…

Japan Japan’s amended Cannabis Control Law now permits the development and medical use of cannabis-derived drugs, particularly CBD-based treatments, while simultaneously criminalizing self-use of smokable cannabis products. Writing in the February 2024 edition of DIA’s Global Forum magazine, Toshi Tominaga of Keio University explains why, despite aligning with evolving international regulations,…

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…