Tagged with EG

India US FDA India Office Director Sarah McMullen discusses the importance of maintaining India’s role as a global supplier of low-cost generics while also navigating the complexities of innovating and producing more complex pharmaceutical products. She notes that increased product complexity will inevitably lead to more regulatory challenges, emphasizing the need…

Africa Medicines for Africa’s Lenias Hwenda argues that the success of the much-talked-about African Medicines Agency hinges on a critical mass of African national regulators achieving WHO Level 3 maturity status. While acknowledging the importance of international actors in making this happen, Hwenda argues that – if the African Medicines Agency…

Saudi Arabia Since joining Moderna as its first ex-US commercial employee in Spring 2020, Dan Staner has played a leading role in developing what is now one of the world’s top 20 biggest pharma companies. Speaking exclusively to PharmaBoardroom, Staner describes how Moderna has been able to fashion a new, optimised company…

China In 2023, the first full year after the COVID-19 pandemic, the National Medical Products Administration (NMPA) set a new record by approving the highest number of new drugs in China in a single year, write Chunrong Yu of Gracell Biotechnologies and Xu Wang of Novo Nordisk (China) Pharmaceuticals in the…

Europe The EMA’s Peter Arlett looks back on two years of the Accelerating Clinical Trials in the European Union (ACT EU) initiative which aims to improve the environment for clinical trials in the EU by transforming how trials are initiated, designed, and run. In conversation following DIA Europe 2024 in Brussels,…

China Chinese biotech Jacobio has made remarkable strides in pioneering first-in-class drug research, with their SHP2 inhibitor project only the second globally to initiate a clinical trial for a novel target and eventually licensed to AbbVie for approximately USD one billion in 2020. Chairman and CEO Dr Wang Yinxiang outlines Jacobio’sstrategic…

Saudi Arabia Ismail Shehada explains his decision to join leading Saudi firm Tabuk Pharmaceuticals, influenced by its potential for growth and strategic transformation in alignment with Saudi Vision 2030. He outlines the need to transition from consultancy-driven strategies to business implementation, aligning with the national agenda and achieving market leadership.   As…

Europe PharmaBoardroom caught up with Niklas Hedberg at DIA Europe 2024 in Brussels to gauge what more needs to be done ahead of the implementation of European HTA regulation in January 2025. Hedberg, who spoke at a host of panels across the event, also gave his take on the EU Pharma…

Japan In conversation at DIA Europe 2024 in Brussels, Shinobu Uzu of Japan’s regulatory agency, PMDA, laid out the organisation’s new five-year plan, how PMDA is hoping to incentivise more biopharmaceutical R&D in the country, and why Japan is “the gateway to Asia” in regulatory terms.   International pharmaceutical companies [should]…

Europe PharmaBoardroom was delighted to attend DIA Europe 2024 in Brussels earlier this month, bringing together a veritable who’s-who of the European and global regulatory community. The politicians, regulators, payers, patient advocates, industry representatives, and service providers in attendance were treated to a three-day buffet of engaging panels and townhalls with…

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 Dr Santosh Indraksha serves as Deputy Drugs Controller (India) for the Central Drugs Standard Control Organisation (CDSCO) under the Indian Ministry of Health and Family Welfare. As a representative of India’s main regulatory body for pharmaceuticals, tasked with overseeing the organisation’s international cell, Dr Indraksha outlines the key upgrades in…