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…
Hong Kong Haematological oncologist Dr Raymond Liang, gives his take on the adoption and challenges of CAR-T therapy in Hong Kong, the necessity of collaboration with mainland China for patient referrals and clinical trials, and the evolution of both Hong Kong’s hospital and regulatory infrastructure, which point to a brighter future for…
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,…
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…
Opinion Writing in the March 2024 edition of the DIA Global Forum magazine, Scott P. Commins of the University of North Carolina School of Medicine, Jasmine Uchi of VeganMed, and Sachin A. Shah of the University of the Pacific address the use of animal-derived ingredients (ADIs) in pharma and outline a…
Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In principle, the regulatory framework set out in the previous Chapters applies. However, differing requirements or procedures apply for specific types of medicinal products. The Medicines Act distinguishes several types of medicinal products, including homeopathic…
India J&J India’s Jayashri Kulkarni lays out her approach to comprehensive leadership, drawing on her diverse career history across various sectors; her mandate to leverage innovative assets to transform disease management in India; and the importance of actively championing diversity, equity, and inclusion (DEI) within the company, building a future-fit organization…
Portugal Speaking to PharmaBoardroom as Janseen is rebranding as Johnson & Johnson Innovative Medicine, managing director for Portugal, Filipa Mota e Costa, discusses the affiliate’s expanded local footprint and its ranking as the number one pharmaceutical company in the country. She also explains Portugal’s market access progress, including the consolidation of…
Europe The European Union’s just-released and first essential medicines list is the latest in a series of measures designed to limit the bloc’s reliance on countries outside its borders and avoid drug shortages. As Elisabeth Stampa of generic and biosimilar lobby group Medicines for Europe recently explained to PharmaBoardroom, this is…
Europe The COVID-19 pandemic and subsequent shortages of essential medicines and APIs laid bare Europe’s reliance on suppliers outside its borders. To combat this issue and ensure that Europe is better prepared for future health crises, the Spanish Presidency of the EU is advocating for a focus on ‘strategic autonomy’ up…
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…
Morocco Sanofi’s Adrien Delamare-Deboutteville describes the access to innovation landscape in Morocco today, how Sanofi is aiming to bolster access in line with the country’s universal healthcare transformation, and the lessons he took from his last position managing the company’s Ukraine operations as war broke out. We want to be…
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