Tagged with Regulatory Reform

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,…

China One of the more eye-catching and ambitious initiatives to come out of last March’s National People’s Congress, Premier Li Keqiang’s grand vision for the cultivation of a globally competitive cluster of metropolises and “innovation super-hub” in China’s Greater Bay Area (GBA), is now starting to take shape as the country…

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…

Spain Santiago de Quiroga, president editor of leading Spanish pharmaceutical industry newspaper El Global and CEO of healthcare communications group WeCare-u, discusses the country’s health priorities, highlighting the upcoming Personalized Medicine Plan that the government will issue by the end of 2018 and predicts how regulators are going to find new…

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…

Spain Humberto Arnés, director general at Farmaindustria, Spain’s leading pharmaceutical industry association, discusses the dynamics of the Spanish pharmaceutical industry showcasing a growth of 2.7 percent of the total public pharmaceutical expenditure while highlighting the association’s strategic plan, revolving around sustainability and access, transparency with healthcare professionals, an increase in industrial…

Canada Bob McLay, vice president and general manager of Sobi in Canada, discusses how innovation and collaboration with regulators and payers are helping Sobi to bring its medicines to Canadians suffering from rare diseases, while emphasizing the importance of an adequate rare disease framework to streamline this process in the future.…

Portugal Heitor Costa, Executive Director for APIFARMA, the Portuguese Pharmaceutical Industry Association, outlines the recent improvements in industry and governmental agreements, the importance of non-prescription medicines, and raising societal awareness on the strengths of OTC medicines. While touching on pertinent topics that affect the entire pharmaceutical production value chain, Costa highlights…

Spain Ángel Luis Rodríguez de la Cuerda, secretary general of AESEG, the trade association of generic producers in Spain, discusses the initiatives that the organization is undertaking to develop a true generic culture in the country and a new proposal changing the requirement for originator drugs to remain at the same…

Ecuador The recently appointed Deputy Minister of Public Health Governance and Surveillance, Dr. Carlos Durán Salinas, elaborates on some of the most recent changes implemented by the government and the tremendous efforts that the administration is making towards the construction of a harmonized and efficient healthcare system in Ecuador, notably in…

Portugal ARSLVT exists to make sure that people living in the Lisbon and Tagus Valley have access to quality health care, adapting the resources available to the region’s health needs and complying with and enforcing the National Health Plan. Luis Pisco is confident in Portugal’s development as a healthy nation, and…

Portugal Maria-Ceu Machado, president of INFARMED the National Authority of Medicines and Health Products, stresses the importance of healthcare restructuring and streamlining work practices in Portugal. In her first year as president, Maria and her team have brought in new rules on medicine approval times, confronted challenges in the reference pricing…