Tagged with regulation

China Eric Bouteiller outlines the paradigm shift occurring in China around rare diseases and how the country has the potential to lead the global pharmaceutical industry in this vital area.   Through exchanges with public officials, academics, representatives of patient associations and industry experts, we sensed a paradigm shift The 8th…

Opinion Within the pharmaceutical space, Eurasia Group’s Aditya Bhattacharji expects politics to drive significant changes in regulatory and legal affairs. He explains how the evolving dynamics can be characterized by two themes.   Regulatory Right-Sizing The status quo is highly unlikely to hold in the regulatory space. The growing and largely…

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…

China China’s pharma market is growing at an unprecedented pace and has become a key element of virtually all pharma multinationals’ international strategies. However, with a spate of regulatory reforms being rolled out, it can be challenging for large organizations with headquarters located in slower-paced mature markets to adapt to China’s…

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…

Lithuania With the end of the Lithuanian Parliament’s Spring Session, a period of neverending discussions and misunderstandings has ended too, as the Parliament and the Ministry of Health have finally adopted a new medicines reimbursement system, writes Ruta Pumputienė.   Lithuanian Ministry of Health deserves compliments for getting involved in 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…

Thailand Dr Jadej Thammatacharee, deputy secretary general of the Thai National Health Security Office (NHSO), outlines the evolution of Thailand’s universal healthcare coverage program, the challenges inherent in its implementation, and the Thai government’s commitment to working with industry to overcome them.   We believe that every Thai should feel secure,…

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…