Romania State hospitals in Bucharest are increasingly overloaded with patients due to a lack of resources and specialists. This pressure is amplified by the fact that many Romanians turn to emergency services for even minor conditions. To rectify this situation, the Romanian state recently passed an emergency ordinance which allows private…
Russia The year 2019, which continued the trend of rapid and numerous changes in healthcare regulations in Russia, was rich with expectations, events and legislative proposals aiming to reform the Russian pharmaceutical industry: medical drugs labeling, reform of price determination, new procedure of entry into drugs civil circulation, amendments to regulatory…
USA Eurasia Group’s Aditya Bhattacharji examines the stalling of healthcare reforms in the US and what changes to US healthcare it is realistic to expect. Pharma is unlikely to be frog-marched by sweeping federal initiatives, but more incremental changes are likely With anti-pharma sentiment raging at the end of 2018,…
Hungary Dr Mátyás Szentiványi, Director General of the National Institute of Pharmacy and Nutrition (OGYEI), introduces the administrative authority and specifies his strategy to be an increasingly collaborative and communicative body of Hungary’s health regulation framework. Dr Szentiványi also goes on to comment on the current key challenges facing the sector,…
USA Peter Marks, director of the US FDA’s Center for Biologics Evaluation and Research, outlines how the organization is attempting to further promote the advancement of cutting edge cell and gene therapies in the US and beyond. To keep pace with the remarkable and continuing growth of gene therapy, FDA’s…
USA The US drug-price watchdog, The Institute for Clinical & Economic Review (ICER) recently issued a “Report on Unsupported Price Increases,” picking a number of innovative medicines that it says have seen price hikes without sufficient substantiation. While the study made the headlines, Certara’s Ulrich Neumann calls for some scepticism and…
China Mike Braun, partner at Deloitte China, shares his perspectives on the recent China reforms, the strong presence of Deloitte within China as a consulting firm with a DNA in professional services, the importance of the healthcare and life sciences industry to their business here, and their commitment to delivering comprehensive…
UAE We look at three of the most important regulatory trends in UAE healthcare and the impact they stand to have on pharma multinationals, local firms, service providers, and patients. There are several regulatory bodies in the UAE, including the Ministry of Health and Prevention (MOHAP), the Dubai Health Authority…
China China’s healthcare system, which impacts 1.4 billion people, is facing serious capacity issues at all stages of the value chain. Against this backdrop, the country is looking at making wholesale changes across the system but with a very pragmatic approach that reflects former leader Deng Xiaoping’s famous adage ‘crossing the…
Thailand Dr Tares Krassanairawiwong, secretary-general of the Thai FDA shares the recent reforms carried out in the hope of facilitating greater patient access to both domestic and internationally-produced treatments. Dr Krassanairawiwong also highlights the institution’s current priorities, including medical cannabis, positioning Thailand as a clinical trials hub, and further developing the…
Sweden Sweden is aiming to become a leading innovation nation in the life sciences, with the creation of a Life Sciences Office showing that the sector is right at the top of the Nordic nation’s political agenda. Today, life science is the only sector for which an official government office…
Opinion Veeva Systems Europe’s Paul Attridge highlights how a switch to a continuous model for regulatory operations could allow biopharmaceutical companies to submit high-quality regulatory submissions for their products faster than ever before. Like continuous manufacturing, which is widely employed in other industries and is starting to show signs of…
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