Tagged with Regulation,

China Writing in the June edition of DIA’s Global Forum magazine, Harbour BioMed’s Fang Zhou, in conversation with Sanofi China’s Irene Deng, looks at how Chinese pharmaceutical regulations have evolved and what impact this has had on regulatory professionals in the country.   The Chinese pharmaceutical industry, through the first five…

Saudi Arabia In a recent conversation with PharmaBoardroom, Prof. Hisham Bin Saad Al-Jadhey, CEO of the Saudi Food and Drug Authority (SFDA) outlined the organisation’s strategic priorities. As part of the Authority’s 2018-2022 strategic plan, it has set out a number of goals, ranging from setting clearer objectives to strengthening its capabilities,…

Saudi Arabia Speaking exclusively to PharmaBoardroom, Prof. Hisham Bin Saad Al-Jadhey, CEO of the Saudi Food and Drug Authority (SFDA), outlines the SFDA’s key priorities under its current strategic plan. He also touches on why domestic pharma and medtech manufacturing is important to the SFDA, pricing issues for innovative new therapies, and…

Europe The full list of medicines recommended for approval by the European Medicines Agency (EMA) in 2020 divided by therapeutic area and with drugs that contained a new active substance highlighted in bold. The EMA approved a raft of new oncology medicines in 2020, as well as new treatments in haematology/…

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…