Tagged with Regulatory

USA In 2020, the US FDA’s Center for Drug Evaluation & Research (CDER) approved 53 novel drugs, up from 48 in 2019, across a range of therapeutic areas, including the first treatments for COVID-19 patients.   The FDA’s Center for Biologics Evaluation & Research (CBER) is charged with approving new biologic…

USA Hours after President Biden was inaugurated on Tuesday 19th January 2021, Dr Janet Woodcock was named as acting commissioner for the Food and Drugs Administration (FDA). “The FDA’s public health work is more critical than ever as we continue to fight this global pandemic… The American people can be certain…

Europe The European Medicines Agency (EMA), Europe’s regulatory body for medicines, has nominated Irish candidate Emer Cooke to as its new executive director at a crucial time for the agency as its powers and priorities shift in the wake of the COVID-19 crisis.   If Cooke accepts and gives an official…

Opinion Song Ruilin, chairman of the China Pharmaceutical Innovation and Research Development Association (PhIRDA) highlights the leaps and bounds with which the Chinese pharmaceutical industry has developed in recent years, the country’s increasingly important role in the global innovation landscape, and why cross-border collaboration is more crucial than ever in the…

Mexico Earlier in 2020, PharmaBoardroom sat down with several key stakeholders in the Mexican healthcare and life sciences industry, from the leaders of multinational affiliates, start-up entrepreneurs, association heads, and key opinion leaders. Here, we round up three of their most talked about topics.   Government  One of the most talked-about…

Belgium Belgian Former Minister of Social Affairs, Public Health and Asylum & Migration Maggie de Block outlines some of the key reforms her Ministry has rolled out since she took office in 2014 and the urgent changes to Belgian healthcare that still need to take place.   Along with the Netherlands,…

Romania Dan Zaharescu, executive director of the Romanian Association of Pharmaceutical Manufacturers (ARPIM), shares his insights on market access, the need to reform pricing methodologies, the debate around the claw-back tax, his expectations for the newly appointed minister of health and prime minister, as well as his objectives for 2020.  …

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…

Chile Against a backdrop of protests against Chile’s market-dominant socio-economic model, President Sebastián Piñera has announced a wave of reforms to address inequalities and improve treatment within the country’s healthcare system. However, there are no guarantees that these motions will pass in their entirety, or that they will quell public dissatisfaction…

Czech Republic Martin Mátl, executive director of the Czech Association of Pharmaceutical Companies (ČAFF), shares the key priorities and challenges of the association and its members; assesses the Czech generics ecosystem, and gives insight into the importance of generics in providing a sustainable healthcare environment with ready availability of medicines for patients.…

Medical Cannabis Thailand has recently gained a new status as the first Asian country to legalise medical cannabis for medical treatment and research. In a sweeping move, the Thai parliament voted unanimously in favor of its legalisation in November 2018, with the bill then signed into law in early 2019.    Starting…

Cyprus Healthcare and life science industry advisory services head at KPMG Cyprus, Iacovos Ghalanos, discusses the challenge of implementing the National Health Insurance Scheme, pricing pressures and how their innovative services help companies manage this crucial trend. Ghalanos also touches on the need for greater collaboration between the public and private…