Singapore As the most important pharma hub in its region, and one of the most important globally, many companies look to launch new products in Singapore first before expanding to other markets. This situation keeps the Health Sciences Authority (HSA) – the country’s regulatory body – extremely busy. While challenges, including…
Canada As the only country in the world to boast a universal healthcare system that does not cover prescription drugs, Canada has been struggling with the concept of ‘national pharmacare’ for a number of years now, with fierce advocates on both sides of the debate. Canada [has] some of the…
Opinion In the wake of a spate of television advertisements for dietary supplements claiming to offer solutions to the COVID-19 crisis, regular PharmaBoardroom contributor Yacine Sellam argues for the need for a more robust regulatory framework in Algeria and even the creation of a unified FDA-style regulator to counter this threat…
Belgium Xavier De Cuyper introduces the Federal Agency for Medicines & Health Products (FAMHP) and the essential role it plays in Belgium’s healthcare regulatory framework since being founded in 2007. De Cuyper goes on to shed light on the organization’s several ongoing priorities which include embracing digital trends, unlocking the potential…
Czech Republic Pharma industry stakeholders are generally quick to suggest that the Czech Republic is one of the most over-regulated markets in Europe, with new or innovative therapies facing significant delays before being able to enter the market. While the timelines are still outside the defined framework, the situation is much…
Japan In April 2019, Yasuhiro Fujiwara was appointed as the new chief executive of Japan’s drug regulator and one of the world’s foremost regulatory bodies, the Pharmaceuticals and Medical Devices Agency (PMDA). Upon appointment, Fujiwara coined the “Four Fs” strategy, urging PMDA employees to have a “patient first,” “access first,” “safety…
USA Barbara Lopez Kunz, CEO of the Drug Information Association (DIA) in the USA, outlines the association’s four key areas of focus – regulatory science, patient engagement, translational science, and value and access – and highlights how it works with stakeholders across the healthcare continuum and across the globe. Across…
Mexico The election of populist President Andres Manuel Lopez Obrador (AMLO) on 1 July 2018 heralded a new era of hope and optimism for Mexicans. In the first 13 months of his term, he has made full use of his popularity. With enviable approval ratings consistently exceeding 60 percent, he has…
Romania State hospitals in Bucharest are increasingly overloaded with patients due to a lack of resources and specialists. This pressure is amplified by the fact that many Romanians turn to emergency services for even minor conditions. To rectify this situation, the Romanian state recently passed an emergency ordinance which allows private…
Russia The year 2019, which continued the trend of rapid and numerous changes in healthcare regulations in Russia, was rich with expectations, events and legislative proposals aiming to reform the Russian pharmaceutical industry: medical drugs labeling, reform of price determination, new procedure of entry into drugs civil circulation, amendments to regulatory…
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 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,…
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