Asia-Pacific Writing in the April edition of DIA’s Global Forum magazine, Dhiraj Behl, Janine Jamieson, and Harikesh Kalonia highlight some of the regulatory challenges for drug-device combination products in APAC, including the lack of an international body dedicated to harmonisation in this field. In the current innovation era and in the wake…
LatAm Writing in the April edition of DIA’s Global Forum magazine, Maria Cristina Mota Pina of Abbvie on behalf of FIFARMA Regulatory & Biologics Working Group highlights the significance of regulatory reliance between regulators in the LatAm and Caribbean region and proposes how it can be strengthened. Regulatory reliance is…
Singapore Dr Choong May Ling, Mimi, CEO of Singapore’s Health Sciences Authority (HSA), one of the leading regulatory bodies in the Asia-Pacific region, outlines the impact of Singapore’s status as a life sciences hub, the launch of novel priority review avenues, and how the authority is adjusting to the new industry…
Europe Writing in the February edition of DIA’s Global Forum magazine, Thomas Kühler of Sanofi R&D looks at the future of European pharma post-Brexit, with the UK diverging from the rest of the continent in regulatory terms and the launch of the European Commission’s Pharmaceutical Strategy for Europe. After four…
China Writing in the February edition of DIA’s Global Forum magazine, Xu Wang of Novo Nordisk Pharma China and Xiaoxi Wang from the Shanghai Center for Drug Evaluation & Inspection analyse the Chinese NMPA’s drug approval list for 2020, including a surge in approvals for locally developed drugs. In the…
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. …
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