Tagged with Regulation

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…

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…

Taiwan Tsung-Tsong Wu, minister without portfolio, offers insights into the current state of Taiwan’s biomedical landscape three years after the administration’s Biomedical Industry Innovation Program was put into place to bolster the industry. Minister Wu also shares his vision on Taiwan’s future as a leader in the emerging digital era.  …

Canada It is not a secret anymore, many in the industry now know that Health Canada is working on a new version of the policy entitled: The Distinction Between Advertising and Other Activities, dated more than 20 years ago. Earlier this week, Health Canada provided some insights about the reformed policy…