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Tagged with Regulation

Key Highlights of China’s New Drug Administration Law
On 26 August 2019, the Chinese legislature, the National People’s Congress (NPC), passed the new Drug Administration Law (DAL), which came into…

The US in 2020: Structural Constraints to Rein in Political…
Eurasia Group’s Aditya Bhattacharji examines the stalling of healthcare reforms in the US and what changes to US healthcare it is realistic to…

Ildikó Horvath – State Secretary for Health, 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…

180-Day Exclusivity: The Key Ingredient in Hatch-Waxman
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…

Three More Key Issues for Pharma: Regulatory Assertiveness,…
Eurasia Group’s Aditya Bhattacharji tackles three more key geopolitical issues that global pharma needs to be cognizant of: the world’s leading…

The Youngest Ever Czech Health Minister’s Ambitious Reform…
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…

Mátyás Szentiványi – Director General, National…
Dr Mátyás Szentiványi, Director General of the National Institute of Pharmacy and Nutrition (OGYEI), introduces the administrative authority and…

US FDA’s Efforts to Advance the Development of Gene Therapy
Peter Marks, director of the US FDA's Center for Biologics Evaluation and Research, outlines how the organization is attempting to further promote the…

Chinese Pharma Legal Update: October 2019
Fangda Partners' Josh Shin gives an overview of recent regulatory upgrades affecting the Chinese pharmaceutical industry. On August 26,…

Catarina Andersson Forsman – Swedish Medical Products…
In a market where revolutionary treatments and new technologies threaten to introduce structural changes, the need for national authorities and…

ICER Strikes Again: Scandal Time?
The US drug-price watchdog, The Institute for Clinical & Economic Review (ICER) recently issued a “Report on Unsupported Price Increases“,…

A New Paradigm for Rare Diseases in China
Eric Bouteiller outlines the paradigm shift occurring in China around rare diseases and how the country has the potential to lead the global…
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