Tagged with Regulator

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…

United Kingdom Life sciences have been steadily losing ground in the UK with a significant drop in global R&D investments and a decreasing number of patients enrolled in clinical trials. The British government has announced a GBP 650 million “Life Sci for Growth” package along with some pro-innovation regulation and a review…

UAE With a welter of regulatory upgrades in the UAE and Saudi Arabia in recent years, patients in the Middle East’s leading countries now have wider and faster access to cutting-edge biopharmaceutical innovation than ever before. Here, four leading lights in the region’s pharmaceutical industry highlight some of the most important…

Saudi Arabia The Saudi Food and Drug Authority (SFDA) has joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S), aimed at harmonising inspection procedures worldwide. Through PIC/S membership the SFDA looks to continue bolstering its capabilities and further its international collaboration efforts.   SFDA’s accession to PIC/S is one of the strategic projects of…

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…

USA During a panel discussion at the BIO International Convention, Peter Marks, director of the US FDA’s Center for Biologics Evaluation and Research (CBER) discussed the positive regulatory outcomes of the COVID-19 pandemic as well as the backlogs it created and the challenges of carrying the lessons learned forward.   At…

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,…

Belgium Xavier De Cuyper of the Federal Agency for Medicines & Health Products (FAMHP), Belgium’s drug regulator, explains the FAMHP’s pandemic response and lessons learned, how the Agency is keeping on top of the rapidly evolving technologies being brought forward today, and the significance of a new early access programme for…

Romania Part of PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece is focused on the expenditure control and cost containment policies that currently exist in the Romanian pharma market. Buy The Pharma Legal Handbook: Market Access & HTA – Romania here for £359.   1.…

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.  …

China China has made major healthcare strides over the past decade with regulatory reforms, infrastructure improvements, and the advancement of universal healthcare. While the COVID-19 pandemic revealed the need for further reform, the country continues to pursue the healthcare transformation goals established in its Health China 2030 program. These aspirations are…

MENA Amira Younes of AbbVie UAE examines how the COVID-19 pandemic highlighted the need for new ways of thinking about delivering regulatory effectiveness and efficiency in the region, and for flexibility from all stakeholders to ensure that therapies continue to reach patients in a timely manner.   Most countries in the…