Tagged with regulatory,

Brazil Brazil’s ANVISA is commonly recognised as LatAm’s leading national medicines regulator and is defined by the Pan American Health Organization (PAHO) as a National Regulatory Authority of Regional Reference (NRAr) for medicines and vaccines. As part of our Transformative 2023: Regional Pharma Trends report, PharmaBoardroom’s Patrick Burton explores some of the key recent…

Morocco Camilia Benani, recently promoted to partner at DLA Piper’s Casablanca office, explains why the Moroccan healthcare sector has become a lightning rod for M&A activity in recent years. Drawing on her experience advising many of the organisations involved in these deals, Benani touches on the evolution of deal structuring in…

Hong Kong Hong Kong provides some of the best and most efficient healthcare in Asia, with Hong Kongers living to over 85 on average (compared to 83 in Singapore and 78 in mainland China), and the World Health Organisation ranks the city among the top 20 healthcare systems globally. However, unlike many…

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…

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…

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…

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…

Denmark Denmark has long been a global frontrunner in medical research ethics and now boasts a more robust ethical infrastructure, spearheaded by a new body, The National Centre for Ethics. Head of the Centre’s Science and Ethics Division Helle Harder explains the rationale behind its formation, how ethics covers the quality…