Tagged with Regulation,

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…

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…

Global The World Health Assembly Special Session on a Pandemic Treaty, which will convene health ministries from around the world in Geneva next week, offers a unique opportunity to take a look back and share some important lessons learnt from fighting the COVID-19 pandemic. James Anderson, Executive Director, Global Health, at…

Japan Writing in the October edition of DIA’s Global Forum magazine, Chief Executive of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) Yasuhiro Fujiwara outlines how his agency has begun to utilise real-world data (RWD) and real-world evidence (RWE) in its regulatory decision-making processes and how this will evolve moving forward.  …

China Song Ruilin, chairman of the China Pharmaceutical Innovation and Research Development Association (PhIRDA), picks out the key learnings from recent legislation to improve China’s drug regulatory capacity and why it potentially marks a new era for the country’s innovative pharma industry.   On April 27, 2021, the General Office of…

Global Over the past 12 months, PharmaBoardroom has spoken to the heads of several key regulatory bodies across the world. While the approval processes for COVID-19 vaccines have evidently been top of their priority lists, other key topics discussed included the potential of data and AI to change the drug approval…

Denmark In a wide-ranging interview, incoming director general of the Danish Medicines Agency Lars Bo Nielsen discusses the challenges that personalised medicine presents to regulators, building a stronger international presence for the Agency, and better leveraging the country’s world-class data infrastructure while respecting the EU’s data protection regulation.   Within Europe,…

Turkey TITCK is the regulatory agency in charge of ensuring the safety of medicines, health products, cosmetics, and personal care products in Turkey. Its recently appointed president, Dr Tolga Karakan, discusses the agency’s work with the WHO, ICH and EU Commission to help Turkish patients and consumers, their experience with emergency…