Tagged with Medicines

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…

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,…

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…

Europe The European Medicines Agency (EMA) recommended 77 drugs for marketing authorisation in 2023, including 39 new active substances, coming up behind the FDA’s record 55 new drug approvals last year. Cancer led the roster of EMA green lights with 25 authorisations, including nine therapies the agency has discerned as major…

Belgium Belgium, one of Europe’s most important countries for biopharmaceutical production and R&D, assumed presidency of the Council of the European Union on the first of January. As part of its Presidency Programme, Belgium has highlighted health as one of its 14 focus areas, with the hope of strengthening the three…

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…

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…

Africa Writing in the July 2023 edition of DIA’s Global Forum magazine, Nevena Miletic of Roche and the IFPMA’s Africa Regulatory Network and Ian Hudson from the Bill and Melinda Gates Foundation look back on the progress made towards instituting an African Medicines Agency and the next steps in this important…

Europe As part of a wide-ranging conversation with PharmaBoardroom published earlier this month, European Medicines Agency (EMA) Executive Director Emer Cooke laid out four of the Agency’s core focus areas for the coming year, including the lessons to be taken from the pandemic response, why antimicrobial resistance must not be neglected,…

Europe As part of the EU’s Pharmaceutical Strategy for Europe, the European Commission has come out with a set of proposals to revise EU pharmaceutical legislation. The reforms, which aim to make medicines more available and accessible across Europe by reducing regulatory exclusivity, speeding up review processes and reinforcing supply chains…

Europe In conversation at DIA Europe 2023 in Basel, European Medicines Agency Executive Director Emer Cooke looks back at the lessons EMA has taken from the COVID-19 pandemic response, outlines the Agency’s approach to antimicrobial resistance, and highlights how it hopes to contribute to a stronger European clinical trials ecosystem.  …