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 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…
Mexico David López García, Mexico country manager of global rare genetic therapy player Biomarin, outlines the challenging situation around patient access to orphan drugs in Mexico and the importance of building awareness of rare diseases. The challenge for orphan drugs is the price. It is not always easy to explain…
Belgium On 3 February 2020 the Act of 20 December 2019 amending various legal provisions concerning shortages of medicinal products was published in the Official Gazette. Except for Articles 2 and 4, which entered into force on 31 January 2020, the act’s provisions entered into force on 13 February 2020. In our view, the…
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…
Hungary Tamás Demeter, Country Manager for AOP Orphan shares his insights on the footprint of the company in Hungary, the areas of therapeutic need that AOP caters to, the performance of 2019 and its key achievements, the ecosystem of rare diseases in Hungary, and patient awareness while highlighting the role of…
Czech Republic Ewopharma’s Jan Krejčí, Country Manager for the Czech affiliate for the last eight years, shares the achievements of the company in its two main business pillars, prescription drugs, and consumer healthcare, and the successful entry into the hospital segment through the challenging and rewarding journey launching Santhera’s orphan drug for…
Czech Republic Medicine shortages are a European-wide issue. In 2016, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) formed a task force to investigate availability issues, including medicines that are authorized but not marketed, and supply chain disruptions in order to improve the continuity of medicine supply across Europe. …
UAE Myriam Hakim, the recently appointed GM for Japanese specialty pharma firm Kyowa Kirin’s UAE affiliate, discusses the strategic significance of the UAE and the Gulf region as a whole to the global group. I appreciate all the efforts the [UAE] authorities have been putting into fast-tracking registration for innovative…
USA In 2019, the US FDA’s Center for Drug Evaluation and Research approved 42 novel drugs, down from 59 drugs approved in 2018. Novartis had four drugs approved, the highest number from any single pharma company. 16 of the 42, or 38 per cent, received orphan drug designation. This listing does…
China Mike Chen, president and CEO of ACROBiosystems, shares his global success as a manufacturer of recombinant proteins supporting biologics R&D and how he hopes to expand his business to eventually set up a multifaceted platform for MNCs and biotechs. By having a manufacturing facility in the USA or Europe,…
Czech Republic Tomáš Votruba of the Association of Full-Line Wholesalers (AVEL), which gathers the three major players of the pharmaceutical distribution market in the Czech Republic, gives an overview of the current priorities and challenges for wholesalers, and how he advocates for the interests of his members by working closely with the…
See our Cookie Privacy Policy Here