Tagged with Regulation

Spain María Ángeles Figuerola, director of SEVeM – the Spanish Medicines Verification System – introduces the mission and mandate of the institute, major challenges, and SEVeM’s role within Spain’s healthcare ecosystem. Please start by introducing the mission and the mandate of the institute. “While we may not yet be feeling the effects…

Canada Canada’s medical cannabis market is valued as a USD 1.3 billion market opportunity, with the recreational market potential worth over USD eight billion. Ontario is the Canadian state with by far the largest number of licensed cannabis producers with 57 compared to just 22 in second-placed British Colombia and seven…

Global The global regulatory landscape for medical cannabis, showing the countries in which medical cannabis and cannabinoid treatments are legal / essentially legal, illegal but often unenforced, decriminalized, and illegal.   Made with Visme Infographic Maker   Click here to download our report on Canada’s world-leading medical cannabis industry

India In a context where even well-established, multi-billion-dollar domestic companies have received warning letters from the US FDA, quality compliance has clearly become strategically important across all layers of Indian organizations, including formulation and API companies as well as both B2B and B2C players.   My approach is extremely simple: quality…

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,…

Malta Andrew Corrieri, founder and CEO at Pharmaconsulta Ltd, tells the story of how he founded his consultancy, as well as the key expertise he can bring to its clients. Moreover, as one of the key experts in the industry, Corrieri takes the time to highlight the key advantages of doing…

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…

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…

Portugal Oscar Gaspar, VP of the Confederation of Portuguese Industry (CIP), president of the Portuguese Association of Private Hospitalization and former secretary of state for health (2009-2011), provides an informative insight into the state of Portugal’s healthcare system. Through compelling suggestions and observations on the current system, Gaspar sheds light on…

Canada Susanne Picard, founder and president at SPharm, speaks about how her passion for regulatory affairs led her to found her own consultancy in 1997 and how the company can look back at an impressive track record of success over the last 21 years. Here, she outlines key priorities to further…

Estonia Kristin Raudsepp, director general of Estonia’s drug regulator – the State Agency of Medicines – discusses her organization’s mandate, current priorities, and reactiveness to the pervading trends in international regulation. Can you introduce the State Agency of Medicines of Estonia and its mandate to our international readers? “Despite of the…

Switzerland With two billion people globally – predominantly in low and middle-income countries – having little or no access to medicine, a select group of service providers have emerged to try and further dialogue between pharmaceutical companies, regulators, healthcare professionals and patients on the issue of expanding access to medicines. At…