Tagged with regulation,

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…

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…

Brazil Leandro Pinheiro Safatle, executive secretary of the Brazilian Drug Market Regulation Chamber (CMED) explains why pharmaceuticals was the only sector to have resisted the country’s recent recession, the role that CMED has played in stabilizing the price evolution of medicines in Brazil, and the importance of increasing the regulatory framework’s…

Canada Colette Rivet, executive director of the Cannabis Canada Association, leading Canadian licensed medical cannabis producers, talks regulatory challenges, upcoming opportunities, export ambitions and collaboration with the provincial and federal government in light of the upcoming legalization of cannabis for adult use in Canada. Colette, can you introduce the Cannabis Canada…

Japan Number of consultations for drugs in Japan by category in 2016. Oncology drugs leads the way, followed by gastrointestinal drugs and respiratory tract drugs. The launch of new medicines for major non-communicable diseases in Japan from 2004-2016 in terms of both applications and approvals. Regenerative medicine product approvals in Japan…

Japan Dr. Tatsuya Kondo is chief executive of Japan’s regulatory authority, the Pharmaceuticals and Medical Devices Agency (PMDA). Since taking the role in 2008, Dr. Kondo, a qualified neurosurgeon with wide-ranging experience in R&D activities, has been responsible for all the operations of PMDA, including relief for adverse health effects of…

Austria Maria Seriakov, CEO and founder of M bioserviceS, a young Austrian company dealing globally that specialises in logistics, regulatory affairs and quality control of biologics, discusses the challenges of navigating differing regulations across the globe as well as the how a hands-on approach ensures a product’s high quality. Furthermore, she…