Tagged with Regulation

Europe The full list of medicines recommended for approval by the European Medicines Agency (EMA) in 2020 divided by therapeutic area and with drugs that contained a new active substance highlighted in bold. The EMA approved a raft of new oncology medicines in 2020, as well as new treatments in haematology/…

Americas Writing in the March edition of DIA’s Global Forum magazine, EMD Serono’s Ana Padua outlines the findings of a recent study into accelerated regulatory pathways in Latin America which aim to reduce approval timelines for innovative medicines.   The Latin America region offers a number of registration pathways to accelerate…

Singapore As the most important pharma hub in its region, and one of the most important globally, many companies look to launch new products in Singapore first before expanding to other markets. This situation keeps the Health Sciences Authority (HSA) – the country’s regulatory body – extremely busy. While challenges, including…

Canada As the only country in the world to boast a universal healthcare system that does not cover prescription drugs, Canada has been struggling with the concept of ‘national pharmacare’ for a number of years now, with fierce advocates on both sides of the debate.   Canada [has] some of the…

USA Dr Peter Marks MD, PhD, director of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), highlights the Center’s contributions related to the regulatory science behind vaccine development, including vaccines to prevent COVID-19; the Center’s efforts to facilitate the advancement of the field…

Opinion In the third of a series of articles chronicling Biogen/Eisai’s Alzheimer’s Disease (AD) treatment aducanumab’s torturous journey to market, Dr Neil Cashman highlights what the next steps in the process will be, why US FDA approval for the drug will pave the way for researchers working on second-generation AD medicines,…

Opinion In the wake of a spate of television advertisements for dietary supplements claiming to offer solutions to the COVID-19 crisis, regular PharmaBoardroom contributor Yacine Sellam argues for the need for a more robust regulatory framework in Algeria and even the creation of a unified FDA-style regulator to counter this threat…

China On March 30, 2020, the State Administration for Market Regulation (SAMR) enacted the Amended Drug Registration Regulation (DRR) as part of its efforts to strengthen and streamline its regulation of the pharmaceutical industry. The DRR seeks, on the one hand, to further confirm a series of changes made in drug…

Romania Dan Minoiu, partner at Romanian law firm Mușat & Asociații, shares his insights into the main trends shaping the healthcare environment in Romania from a regulatory and legal perspective, the challenges currently facing his clients, and his hopes for the future of the country.   Our clients always stress how…

Pricing Pushback from drug companies on Canada’s newest drug pricing regulations has led the country’s regulatory body to reconsider their implementation. Companies cite the push for cost-effectiveness as a reason for withdrawing drug approval applications, cutting jobs, or delaying launches, claiming the new pricing regulations will substantially reduce revenues.    The…

Belgium Xavier De Cuyper introduces the Federal Agency for Medicines & Health Products (FAMHP) and the essential role it plays in Belgium’s healthcare regulatory framework since being founded in 2007. De Cuyper goes on to shed light on the organization’s several ongoing priorities which include embracing digital trends, unlocking the potential…

Czech Republic Pharma industry stakeholders are generally quick to suggest that the Czech Republic is one of the most over-regulated markets in Europe, with new or innovative therapies facing significant delays before being able to enter the market.   While the timelines are still outside the defined framework, the situation is much…