Tagged with Regulation,

USA Francesco Lanucara of PharmaLex, writing in the November 2023 edition of the DIA’s Global Forum magazine takes a look at how new guidance from the US FDA aims to tackle the myriad challenges of cell and gene therapy manufacturing comparability and complexity.   Development of cell and gene therapy (CGT)…

Europe Pfizer’s David Isom and Monica Mihedji, writing in the November 2023 edition of the DIA’s Global Forum magazine, examine how the European Medicines Agency is attempting to integrate the use of artificial intelligence in its regulatory work.   Regulators are advancing information technology and data modernization initiatives to drive more…

Morocco   General Director Dr Aziz Mrabti discusses the Moroccan Medicines & Pharmacy Directorate (DMP)’s transition to an independent regulatory authority, highlighting its potential to enhance autonomy and international recognition. He also emphasizes Morocco’s commitment to supporting the growth of the healthcare and pharmaceutical sectors, both domestically and internationally, amid the…

Brazil The DIA Global Annual Meeting 2023 hosted DIA’s first regulatory Town Hall fully dedicated to one regulator from Latin America, as leadership from Brazil’s Health Regulatory Agency, ANVISA, shared updates on the country’s regulatory priorities, the agency’s strategic priorities, and local trends, as well as ongoing regulatory convergence and collaboration initiatives. This…

Americas Writing in the August edition of DIA’s Global Forum magazine, Silvia B. Bendiner of WESSX Inc. and Belkis Romeu call for greater regulatory collaboration between Latin American countries, building on an initiative created by Dr. Rafael Pérez Cristiá at the Cuban Regulatory Authority (CECMED).   The need for further regulatory…

China Writing in the August edition of DIA’s Global Forum magazine, Wen Yin of the Pfizer China R&D Center and Wanhe Deng of GSK China Investment look back on four years of China’s marketing authorization holder (MAH)-based regulatory system, including the opportunities it presents, and some of the implementation challenges.  …

Europe Rainer Westermann, chairman of the Life Sciences Acceleration Alliance e.V. (LSAA), which lobbies on behalf of European venture capitalists in the life sciences space, critiques the draft EU Pharma Regulation from a VC perspective, arguing that the continent’s status as a medical innovation hub is at risk if the EU…

Europe Rainer Westermann, chairman of the Life Sciences Acceleration Alliance e.V. (LSAA), which lobbies on behalf of European venture capitalists in the life sciences space, launches a critique of current pharmaceutical policies across the EU, arguing that constant cost-containment measures, over-regulation, and bureaucracy are leading to drug shortages and acting as…

Europe The much-discussed implementation of an EU-wide legislative framework on health technology assessment (HTA) will finally come to fruition in 2025, explains EUnetHTA Chair Niklas Hedberg. He outlines the need for this framework given the sheer influx of new products and the limited capabilities of individual countries and why the intervening…

USA PhRMA President and CEO Stephen J. Ubl takes aim at the health insurers and pharmacy benefit managers (PBMs) driving medicines costs up in the US, and the Inflation Reduction Act (IRA) which he sees as failing to address the patient affordability conundrum. Ubl calls for a policy framework able to…

Africa Speaking exclusively to PharmaBoardroom, Medicines for Africa’s Lenias Hwenda gives a comprehensive overview of the African Medicines Agency, why such a regulatory body was needed, how it differs from the European Medicines Agency, and its progress thus far. Hwenda also examines how the AMA stands to impact Africa’s clinical trial…

Greece In Greece, both innovators and the generics industry find fault with the country’s rebates and clawbacks system, a hold over cost-containment measure from the country’s period of extreme economic turmoil. In conversation with PharmaBoardroom, Michael Himonas, GM of the Hellenic Association of Pharmaceutical Companies (SFEE) and Faye Kosmopolou, GM of…