Tagged with Regulator

Hong Kong Professor Justin Wu, chief operating officer of the Chinese University of Hong Kong (CUHK) Medical Center, shares his professional background and interest in gastroenterology, his insights into the research and commercialization environment in Hong Kong, and his hope for government, industry and academia to work together to propel Hong Kong…

Regulatory This week Novartis received approval from the European Commission (EC) for Kymriah, their chimeric antigen receptor T cell (CAR-T) therapy for young people under 25 with cancer of the blood. Leading the way in innovative cancer cures with an unrivalled portfolio of over 20 approved oncology medicines, Novartis is the only company in the…

Turkey Dr. Ümit Dereli and Cengiz Aydın of the Association of Research-Based Pharmaceutical Companies (AIFD) inTurkey discuss significant recent changes in the Turkish ecosystem, including the improving recognition of the country’s regulatory agency, new pricing and localization policies, AIFD’s contribution to Turkey’s 11th Development Plan, and the ambition to make Turkey “a…

Portugal Portugal’s Minister of Health, Adalberto Campos Fernandes, details his three-tiered plan for national health in Portugal. He explains that empowering citizens, transforming the sector digitally and ensuring that the proximity of care is readily available to the entire nation are vital elements to combatting pressing problems concerning debt, an aging…

Regulation Herbal-based medicines or botanics have attracted strong attention around the world as part of a growing consumer enthusiasm for natural products, and in the face of a ‘prescription cascade’ in which severe side effects from combinations of classic medicine are becoming a health risk in themselves. However, regulatory frameworks have,…

China One of the more eye-catching and ambitious initiatives to come out of last March’s National People’s Congress, Premier Li Keqiang’s grand vision for the cultivation of a globally competitive cluster of metropolises and “innovation super-hub” in China’s Greater Bay Area (GBA), is now starting to take shape as the country…

India Dr. Letitia Robinson, Director of the US FDA India Office, provides insights into the main goals and responsibilities of the FDA in India and documents the US FDA’s collaboration efforts with its Indian regulatory counterparts. Could you introduce to our international readers the US FDA’s Office of International Programs and…

Spain Santiago de Quiroga, president editor of leading Spanish pharmaceutical industry newspaper El Global and CEO of healthcare communications group WeCare-u, discusses the country’s health priorities, highlighting the upcoming Personalized Medicine Plan that the government will issue by the end of 2018 and predicts how regulators are going to find new…

Pharma While drug developers, healthcare practitioners and patients all rejoice at the advent of a golden age of scientific advancement in medicine – symbolized by recent radical breakthroughs in all manners of domains from stem cells and CAR-T generation immunotherapy to gene tech and 3D bio-printing – it is clear that…

Spain Humberto Arnés, director general at Farmaindustria, Spain’s leading pharmaceutical industry association, discusses the dynamics of the Spanish pharmaceutical industry showcasing a growth of 2.7 percent of the total public pharmaceutical expenditure while highlighting the association’s strategic plan, revolving around sustainability and access, transparency with healthcare professionals, an increase in industrial…

Canada Bob McLay, vice president and general manager of Sobi in Canada, discusses how innovation and collaboration with regulators and payers are helping Sobi to bring its medicines to Canadians suffering from rare diseases, while emphasizing the importance of an adequate rare disease framework to streamline this process in the future.…

Portugal Heitor Costa, Executive Director for APIFARMA, the Portuguese Pharmaceutical Industry Association, outlines the recent improvements in industry and governmental agreements, the importance of non-prescription medicines, and raising societal awareness on the strengths of OTC medicines. While touching on pertinent topics that affect the entire pharmaceutical production value chain, Costa highlights…