Tagged with regulation

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…

Ukraine Tetyana Dumenko, director of the State Expert Center (SEC) of the Ministry of Health of Ukraine, the regulatory agency responsible for product registration, pre-clinical studies and clinical trials approval and pharmacovigilance, provides insights into some of her initial achievements since taking the position and her main strategic priorities to further…

Colombia In explaining the role of the Colombia National Food and Drug Surveillance Institute (INVIMA) and its impact on the regulatory landscape of the healthcare sector, Javier Guzman, Executive Director, centres the discussion on four key pillars: institutional strengthening, efficiency, transparency and competitiveness. He speaks about his main priorities, the Colombian…

Mexico Luisa Gutierrez, CEO at Medisi, explains the importance of helping get fast registration for high quality medtech products registrations and explains Medisi’s integral solutions for both the regulation and distribution of medical devices. Ms. Gutierrez you have quite an unusual professional profile. What triggered you to start your entrepreneurial journey…

Mexico Representatives of Olivares, one of the leading law firms in Mexico, explain the evolving status of cannabis and narcotics for medicinal use in the country. A new Bill authorizing the use of cannabis for medical treatments was passed by the Senate in December 2016, but there is still a long…

Mexico Fausto Hernández, CEO at ValidPro, explains the unique business model of the company as well as the high added value of its qualification and validation services; offering integral solution that position ValidPro as the regulatory partner of choice for the pharmaceutical industry. Could you please introduce yourself to our international…

USA While pledging to lower drug prices has proved popular, the Trump administration’s proposed FDA reform has been getting some pharmaceutical executives worried. In a meeting with Big Pharma CEOs at the end of January; US President Donald Trump called for drug prices to be lowered, US production of medicines to…

France In an exclusive interview, Agnès Buzyn, Chairwoman of the Board for the French National Authority for Health (Haute Autorité de Santé – HAS), on her organization’s priorities, the particularities of the French healthcare system, and what can be learned from other countries’ systems. Your career includes experiences as a doctor,…