Tagged with Regulation,

Denmark In conversation at DIA Europe 2024 in Brussels, Lars Bo Nielsen lays out the digital transformation that the Danish Medicines Agency has undergone over the past three years and how AI can best be integrated into the work of national regulatory bodies.   What does AI really mean? How can…

India The State of Gujarat is one of India’s most culturally diverse, the birthplace of ‘Father of the Nation’ Mahatma Gandhi, and the only place in the world where Asiatic lions can be found in their natural habitat. It is also an economic powerhouse, with key Gujarati industries including dairy, cement,…

Morocco Morocco is currently implementing the most ambitious, far-reaching, and comprehensive health system reorganizations in its history. “What sets this reform apart from all that has happened before is just how starkly it differs in spirit from previous incremental and piecemeal initiatives that have been attempted over the decades,” proudly asserts…

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…