Tagged with regulatory

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…

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.…

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…

UAE As a part of its continued digitalisation efforts, the United Arab Emirates (UAE) has launched the region’s first pharmaceutical track-and-trace system, Tatmeen. With the new system, which will monitor each stage of drug production, the country aims to boost transparency, eliminate the sale of counterfeit medicines, build trust in the…

Switzerland An extract from PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece gives the lowdown on price controls and reference pricing systems in Switzerland. Buy The Pharma Legal Handbook: Market Access & HTA – Switzerland here for £359.   1.1 How does price control at…

Brazil The latest from Brazilian Pharma, including the controversial proposal to transform Brazil’s regulatory agency, ANVISA; Ease Labs’s canabidiol approval, Biolab’s international expansion ambitions and Eurofarma’s multiple myeloma deal.    ANVISA’s autonomy challenged by Congress (Regulatory Focus) After the swearing in Brazilian’s President Luiz Inácio Lula da Silva earlier this year,…

Japan Writing in the February 2023 edition of DIA’s Global Forum magazine, Yumi Wakabayashi of Janssen, Takahiro Horimatsu from the Institute for Advancement of Clinical and Translational Science at Kyoto University, Hiroshi Asai of Astellas, Yasuhiro Himeno from the Government of Japan’s Cabinet Office, and Hiroyuki Taruno of the Cancer Institute…