Tagged with regulation

Europe Writing in the June 2023 edition of DIA’s Global Forum magazine, Angelika Joos of MSD and Susanne Ausborn Roche consider some of the key takeaways from a workshop on regulatory reliance at DIA Europe 2023 which brought together international representatives from both industry and regulatory bodies.   Reliance* is considered the…

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…

Europe Edward Mc Gettrick and Sharon Gorman of Pfizer, writing in the January 2023 edition of DIA’s Global Forum magazine, examine the scope and impact of the European Union’s new Regulation on Health Technology Assessment.   In December 2021, the European Commission (EC) adopted the Regulation on Health Technology Assessment (EU HTA…

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…

Europe Writing in the special December 2022 edition of DIA’s Global Forum magazine, Eli Lilly’s Mark Mayer, Pfizer’s Nick Sykes and Julie O’Brien, and the EFPIA’s Sini Eskola, Magda Chlebus, and Chloé Garay look at the EU regulatory system’s resourcing challenges and call for long-term multi-stakeholder engagement to help resolve them.…

USA Reflecting on a transformational decade at the helm of the Drug Information Association (DIA), Barbara Lopez Kunz highlights some of the key achievements and most significant trends that have emerged during her tenure. Lopez Kunz points to the DIA’s evolution into a truly global knowledge-sharing platform, the COVID-19 pandemic’s impact…

Egypt First founded in 2019 as a new regulatory body independent from Egypt’s Ministry of Health, the Egyptian Drug Authority (EDA) has made significant progress over the last three years. Now recognised as one of the MEA region’s leading regulators, the EDA can point to several notable successes in Egypt’s battle…

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…

Japan Pfizer’s Kaneko Miyuki, writing in the September 2022 edition of DIA’s Global Forum magazine, shines a light on Japan’s new emergency approval system for pharmaceuticals. Enacted in the wake of the COVID-19 pandemic, Japan hopes that this new regulation will allow for a more rapid and agile response to future…

Europe In an extensive recent PharmaBoardroom conversation, EMA Head of Advanced Therapies Ana-Hidalgo-Simon highlighted some of the most important trends around advanced therapy regulation in Europe. Hidalgo-Simon touched on why moderate growth in regulatory applications is a positive development for the EMA, how patient insights are being better incorporated into the…

Europe Speaking exclusively to PharmaBoardroom, the EMA’s Head of Advanced Therapies Ana Hidalgo-Simon discusses steadily growing numbers of regulatory applications in the advanced therapy field, the vital importance of patient group insights, RWE collection and curation, hospital exemptions, manufacturing challenges, and more.   [Advanced] therapies are complex, difficult, and have a…