Tagged with Regulation

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…

Czech Republic A cross-industry push for better and broader access to innovative treatments is underway in the Czech Republic. Ripe for reform is the country’s orphan drug legislation as no standard pathway for their assessment, pricing and reimbursement currently exists.   [For cancer treatment the country has been] quite successful in moving…

Japan In April 2019, Yasuhiro Fujiwara was appointed as the new chief executive of Japan’s drug regulator and one of the world’s foremost regulatory bodies, the Pharmaceuticals and Medical Devices Agency (PMDA). Upon appointment, Fujiwara coined the “Four Fs” strategy, urging PMDA employees to have a “patient first,” “access first,” “safety…

USA Barbara Lopez Kunz, CEO of the Drug Information Association (DIA) in the USA, outlines the association’s four key areas of focus – regulatory science, patient engagement, translational science, and value and access – and highlights how it works with stakeholders across the healthcare continuum and across the globe.   Across…

Mexico Rafael Gual Cosío, director general of the Cámara Nacional de la Industria Farmacéutica (CANIFARMA), the umbrella industry association for the healthcare sector in Mexico, shares his perspectives on the complex situation in the Mexican healthcare landscape today; the importance of positive and open working relationships between the public and private…

USA In an exclusive interview, Janet Woodcock, head of the Center for Drug Evaluation and Research (CDER) at the US Food & Drug Administration (FDA) outlines how the world’s gold-standard agency for regulatory science is adapting to game-changing and often extremely expensive new therapies, why a sizeable impact from data and…

Mexico The election of populist President Andres Manuel Lopez Obrador (AMLO) on 1 July 2018 heralded a new era of hope and optimism for Mexicans. In the first 13 months of his term, he has made full use of his popularity. With enviable approval ratings consistently exceeding 60 percent, he has…

Romania State hospitals in Bucharest are increasingly overloaded with patients due to a lack of resources and specialists. This pressure is amplified by the fact that many Romanians turn to emergency services for even minor conditions. To rectify this situation, the Romanian state recently passed an emergency ordinance which allows private…

Russia The year 2019, which continued the trend of rapid and numerous changes in healthcare regulations in Russia, was rich with expectations, events and legislative proposals aiming to reform the Russian pharmaceutical industry: medical drugs labeling, reform of price determination, new procedure of entry into drugs civil circulation, amendments to regulatory…

USA Takeda’s Jessica S. Scott examines the steps already being taken to bring greater patient engagement to drug development and the regulatory decision-making process in the USA; as well as what more needs to be done in this crucial area.   Steps Taken by FDA Under the Food and Drug Administration…