Tagged with Regulation

China On 26 August 2019, the Chinese legislature, the National People’s Congress (NPC), passed the new Drug Administration Law (DAL), which came into effect on 1 December 2019 and represents one of the most important milestones for the Chinese healthcare industry. This is only the second systematic and structural major revision…

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 Ildikó Horvath, Hungary’s State Secretary for Health explains her role and shares insights on the key health trends in Hungary, the government’s top priority in improving healthcare, the importance of digitalization, and efforts made to close the life expectancy gap with Europe.   Hungary is on average five years…

Opinion The AAM’s Chip Davis looks back on 35 years of healthcare system savings from generic pharmaceuticals in the US, and the peril the generics industry faces from the Lower Health Care Costs Act.   A key provision of our generic pharmaceutical architecture is in jeopardy. The “180-day exclusivity” is the…

Opinion Eurasia Group’s Aditya Bhattacharji tackles three more key geopolitical issues that global pharma needs to be cognizant of: the world’s leading drug regulators becoming increasingly strident and active beyond national borders; the impact that greater awareness and work on climate change could have on the industry; and the risks surrounding…

Czech Republic The Czech Republic’s Minister of Health,  Adam Vojtěch, is the youngest in the country’s history and has set out an ambitious reform programme to improve the state of the Czech healthcare system.   In my office, I will actively seek to fulfil the key points of my election program –…

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…

China Fangda Partners’ Josh Shin gives an overview of recent regulatory upgrades affecting the Chinese pharmaceutical industry.   On August 26, 2019, China enacted the Amended Drug Administration Law as part of its efforts to strengthen and streamline its regulation of the pharmaceutical industry. The amended law seeks to address prominent…

Sweden In a market where revolutionary treatments and new technologies threaten to introduce structural changes, the need for national authorities and regulators to adapt and catch up with the pace of the industry is of uttermost importance. Dr Catarina Andersson Forsman, director general of the Swedish Medical Products Agency (MPA), shares…

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 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…