Tagged with Regulator

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…

Austria Alexander Biach, chairman of the Main Association of Austrian Social Security Institutions, discusses handling the responsibility for Austria’s Europe-leading social security coverage, current inefficiencies that need to be ironed out, and his blueprint for creating a faster, less complicated, more cost-effective, and equitable social insurance system. Last May, you were…

Lithuania Gintautas Barcys, director of the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania (SMCA), explains the increasingly significant role of the SMCA on a national and European level and highlights some of the most successful initiatives implemented by the institution over recent years. Can…

Poland Irena Rej, president of the Polish Pharmaceutical Chamber, Farmacja Polska, discusses the trends of the domestic pharmaceutical market and the recent changes to improve the introduction of innovative products. Furthermore, she highlights the strengths of the local OTC industry and the chamber’s role in facilitating active dialogue with key stakeholders…

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…

EMA The European Medicines Agency (EMA), the EU body responsible for the evaluation of medicinal products for use within the European Union, concluded a vote on Monday evening in Brussels following three rounds of voting. “We are delighted, it was very tight, it was nerve-wracking, to be honest” Halbe Zijlstra, Minister…

Lithuania Rūta Pumputienė, head of the Local American Working Group (LAWG), explains the main dynamics impacting the pharmaceutical sector in general as well as the key role of the LAWG in supporting the better access to innovative treatments. Can you please introduce yourself to our international audience as well as the…

Tunisia Jade Salhab, senior private sector development specialist at World Bank Tunisia, discusses the impact of the public-private dialogues initiated by his organization in Tunisia, and the additional measures needed to improve healthcare outcomes in Tunisia The World Bank, in response to a request from the government of Tunisia, facilitated a…

India Dilip G Shah, secretary-general of the Indian Pharmaceutical Alliance (IPA) and member of the Expert Review Committee on Access to Medicine (ATM), discusses the association’s commitment to assisting the Indian government with policies that ensure access to affordable medicines for all as well as the requirements that every candidate needs…