Tagged with regulation,

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…

Sweden The Life Sciences Office Sweden was commissioned in February 2018 and is modelled on the UK’s Office for Life Sciences. Jenni Nordborg, the Office’s director and national coordinator, discusses the future of the life sciences sector in Sweden, including digitalization and collaborations with other Nordic nations.   I believe in…

Taiwan Yu-Ih Hou, mayor of New Taipei City, introduces the city and highlights its key competitive advantages and strategic direction of growth as Taiwan’s top economic and cultural destination.   Over one-fourth of Taiwan’s biomedical industry is based in the greater Taipei community – most of which are small companies carrying…

Croatia Lawyer Ira Perić Ostojić highlights recent regulatory updates in Croatia, where the legal status of cultivating and producing cannabis for medical purposes has been liberalised.   On 25 April 2019 the Amendments to the Act on Combating Drugs Abuse entered into force in Croatia, which liberalizes the cultivation and production…

Lithuania Ruta Pumputiene examines recent regulatory reform in Lithuania, as the Baltic nation attempts to introduce a holistic HTA mechanism for the evaluation of what to include on the country’s reimbursable medicines list.   It is not yet clear whether the new procedure will complicate and damage Lithuanian patients’ access to…