Tagged with regulatory

Baltics Janis Silins of the Association of Biopharmaceutical Drug Manufacturers in Latvia discusses the organization’s purpose, collaboration efforts, and role in shaping policy reform. Could you please start by introducing the Association of Biopharmaceutical Drug Manufacturers in Latvia (Biofarmaceitisko Ražotāju Asociācijas Latvijā (BRAL)) and your role within the association? “We strive…

Serbia Between 2010 and 2012 just one of the 139 new medicines to receive market authorisations globally was approved for reimbursement in Serbia, compared with 44 in Bulgaria and 27 in Croatia; meaning a severe lack of patient access to much-needed treatments as well as an extremely challenging environment for innovative…

Lithuania Kristina Garuoliene, vice minister at the Ministry of Health of the Republic of Lithuania, explains the cornerstones behind the new National Drug Policy approved in August 2017, the commitment of the Ministry to ensuring Lithuanian patients have access to the latest high-quality medicines regardless of their location or spending power.…

Brazil Paulo Henrique Fraccaro, superintendent of the Brazilian Medical and Dental Devices Manufacturers Association (ABIMO), describes the central role of the association within the Brazilian medtech industry, the phenomenal potential of Brazil’s medtech sector for companies choosing to establish a production facility in Brazil and the importance of increased efficiency and…

Lithuania Šarūnas Narbutas, president at the Lithuanian Cancer Patients’ Coalition (POLA), explains the role of patients in shaping the Lithuanian healthcare system as well as the importance of having an integral approach when discussing with healthcare stakeholders to drive progress in the country. You hold a number of roles in different…

India A nationwide renowned neonatologist and member of the High Level Expert Group on Universal Health Coverage, NITI Aayog’s medical expert, Dr. Vinod K. Paul introduces the work that the government institution has been carrying out to improve India’s healthcare system since its creation in 2015 and discussed how India is…

India Newly appointed commissioner of the Food & Drugs Administration (FDA) of the Indian state of Maharashtra, Dr. Pallavi Darade, shares her objectives to further consolidate the FDA’s positioning as a transparent, efficient and trusted regulatory institution by involving the industry in any consultation and make them an integral part of…

Switzerland Petra Doerr, head of sector communication & networking as well as deputy executive director of Swissmedic, the Swiss surveillance authority for medicines and medical devices, discusses changes to the Swiss regulatory system and harmonizing the organization with its global counterparts. Swissmedic has embarked upon a comprehensive overhaul of its regulations in response…

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…

India Kanchana TK, director general of the Organisation of Pharmaceutical Producers of India (OPPI), the association which represents the interests of research-based pharmaceutical companies in India, discusses regulatory reform and how OPPI is helping to shape the Indian healthcare system. Please introduce yourself to our international readers and your journey to…

Lithuania Darius Sinkevičius, chairman of the board at the Lithuanian Association of Generic Pharmaceuticals Manufacturers (VGA), explains the main trends impacting the generic pharmaceutical industry in the country as well as the role of off-patent medicines in creating savings for the Lithuanian healthcare system. Can you give to our international audience…

Serbia Vera Nikolic-Dimic, executive director of the American Chamber of Commerce (AmCham) in Serbia, pinpoints the key facets of the Serbian economy that have captivated the interests of American businesses, the challenges and opportunities companies operating in the country are currently facing, as well as the Chamber’s fundamental role in promoting…