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Portugal While not a major player in clinical trials at the European level, Portugal has untapped potential in this field, leveraging a first pioneering centre in Braga, the country’s strong scientific community, a growing openness to collaboration with industry, and access to a European patient database. Considering the remarkable progress that…

Switzerland For the Swiss Agency for Therapeutic Products (Swissmedic), one of the world’s leading regulatory authorities, 2023 was an important year. Not only did the agency gain recognition from the World Health Organisation (WHO), Swissmedic also saw a Good Manufacturing Practice (GMP) agreement between Switzerland and the US FDA come into…

Portugal Monica Bettencourt-Dias of the Gulbenkian Institute for Science highlights the IGC’s pioneering role in biological sciences, supporting scientists and innovators who have significantly contributed to the field globally for over 63 years. She also touches on Portugal’s scientific excellence, how the IGC is balancing fundamental research with initiatives for technology…

Portugal Nuno Sousa details the development of Portugal’s clinical research ecosystem, highlighting the creation of the Clinical Academic Center of Braga (2CA-Braga) and its evolution. He emphasises the necessity of building on 2CA Braga’s successes to create a network of strong research centres across Portugal, making the country a more competitive…

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…

Spain Having forged a solid position in clinical research in 2020 and 2021 when it became the fourth nation in the world and the first in Europe for studies conducted around COVID-19, Spain has continued consolidating its status as a leading clinical trials hub and registered over 900 trials in 2022,…

Portugal Marco Dietrich highlights some of the key challenges in Portugal’s healthcare system, Bayer Portugal’s continuing focus on introducing new products – particularly in diabetes, where Portugal has the highest prevalence in Europe –, and how he has led the strategic transformation of the affiliate focusing on agility and cost-effectiveness.  …

Portugal A staunch advocate for diversity and inclusion, Helena Freitas today leads the Portuguese affiliate of Sanofi, consistently ranked among the leading pharmaceutical firms in the country. With a focus on growth in the hospital setting as well as addressing the high incidence of diabetes in Portugal, Freitas is confident of…

USA The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) approved no less than 55 new drugs in 2023, a number surpassing that of 2022 by almost 50 percent. While 28 rare disease treatments and five novel gene therapies got the green light, the agency also…

Portugal Mario Martins lays out IQVIA Portugal’s holistic approach to the healthcare sector, covering clinical trials, therapeutic studies, and technology solutions such as compliance CRM and quality control for manufacturing plants. He also foregrounds the importance of both local adaptation and global collaboration in capitalising on the unique challenges and opportunities…

Japan Toshi Tominaga of Keio University Hospital, writing in the January 2023 edition of the DIA Global Forum magazine, outlines some recent updates to Japanese drug registration legislation, including how domestically generated academic clinical data can be utilised.   Japan’s current regulatory framework for investigator-initiated trials (IITs) of drug candidates seems…

India Managing director & CEO of Ferring India, Sudheendra Kulkarni, whose responsibilities have grown to cover the entire 10-country South Asia & ASEAN cluster, speaks about Ferring’s Indian footprint, which includes local API production and product development, and the 18-20 percent growth the affiliate saw in 2023. He discusses the relevance…