Tagged with Regulator

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…

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 EMA’s Head of Advanced Therapies Dr Ana Hidalgo-Simon outlines Europe’s evolving regulatory framework for regenerative medicines, how it differs from those in the USA and Asia, ethical and pricing challenges, and why global regulatory harmonization and collaboration is crucial.   For advanced therapies, market approval is not the end…

UK When the European Medicines Agency (EMA) relocated from London to Amsterdam after the UK announced its decision to leave the European Union, some analysts feared that Britain could become left behind in terms of alignment with the world’s top regulatory bodies. Perhaps cognizant of this, the UK regulatory agency for…

USA Dr Peter Marks MD, PhD, director of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), highlights the Center’s contributions related to the regulatory science behind vaccine development, including vaccines to prevent COVID-19; the Center’s efforts to facilitate the advancement of the field…

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…