Tagged with Regulator

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…

Belgium Belgian Former Minister of Social Affairs, Public Health and Asylum & Migration Maggie de Block outlines some of the key reforms her Ministry has rolled out since she took office in 2014 and the urgent changes to Belgian healthcare that still need to take place.   Along with the Netherlands,…

Romania Dan Zaharescu, executive director of the Romanian Association of Pharmaceutical Manufacturers (ARPIM), shares his insights on market access, the need to reform pricing methodologies, the debate around the claw-back tax, his expectations for the newly appointed minister of health and prime minister, as well as his objectives for 2020.  …

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…

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…

Chile Against a backdrop of protests against Chile’s market-dominant socio-economic model, President Sebastián Piñera has announced a wave of reforms to address inequalities and improve treatment within the country’s healthcare system. However, there are no guarantees that these motions will pass in their entirety, or that they will quell public dissatisfaction…

Czech Republic Martin Mátl, executive director of the Czech Association of Pharmaceutical Companies (ČAFF), shares the key priorities and challenges of the association and its members; assesses the Czech generics ecosystem, and gives insight into the importance of generics in providing a sustainable healthcare environment with ready availability of medicines for patients.…

Sweden In a market where revolutionary treatments and new technologies threaten to introduce structural changes, the need for national authorities and regulators to adapt and catch up with the pace of the industry is of uttermost importance. Dr Catarina Andersson Forsman, director general of the Swedish Medical Products Agency (MPA), shares…

Medical Cannabis Thailand has recently gained a new status as the first Asian country to legalise medical cannabis for medical treatment and research. In a sweeping move, the Thai parliament voted unanimously in favor of its legalisation in November 2018, with the bill then signed into law in early 2019.    Starting…

Spain María Jesús Lamas, director and César Hernández García, head of medicines for human use at the Spanish Agency of Medicine and Health Products (AEMPS), discuss the challenges impacting the evaluation and analysis of products today. Furthermore, they give insights into why Spain is a leading global clinical trials destination and…

Malaysia Dr Ramli Zainal, the director at National Pharmaceutical Regulatory Agency (NPRA), expresses the continuous work of NPRA to build a strong regulatory ecosystem in Malaysia and the important role that the Malaysian regulator has in the ASEAN region. He also takes time to explain the upcoming priorities to further establish…

Regulation Dominique Martin, CEO of the ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) provides a fascinating insight into the French process of authorizing drugs and medical products, his commitment to increased transparency and increased efficiency, and the opportunity for France to take the lead in European…