Comparative analysis of evolution of regulatory environment in USA, Europe and Japan
Sandeep Kumar Dhiman and Harish Dureja
The industry of healthcare products is the utmost regulated segment as patients are not equipped with expert knowledge to determine the efficacy, safety, and quality of these products. Thus, the regulations come into play to ensure effectiveness and safety of healthcare products. The regulatory environment throughout the world is transforming incessantly to make it viable and objective. United States of America (USA), Europe (EU), and Japan are the most regulated geographies in the world. USA is the largest pharmaceutical market. Europe as a collective region is the second biggest pharmaceutical market. Japan, however, is the third largest single country market of pharmaceuticals. The objectives of the present study are to gain evidence on the existing regulatory set-up, key areas of regulatory focus and relative analysis of the evolution of regulatory environment in the USA, Europe, and Japan. The methodology used is a relative study based on original research carried out based on evidence available from universal resources and analysis of the facts, statements, and projections of regulatory focus. The findings included various areas of regulatory focus in three geographies including user fee, paediatric research, clinical trials, drug safety, anti-counterfeit/falsified medicines, price reimbursement policies, regulatory compliance, medical devices and biologicals regulations, ICH Q12 guideline, veterinary product reforms, review and approval pathways/timelines, breakthrough therapies, endocrine disruptors, and collaborative approaches etc. As internationally leading regulators, USFDA, EMA, and PMDA are working on specific areas of local and global interest in regulating healthcare products segment. The comparative analysis reflects discrete and overlapping goals to being reforms in regulating healthcare products.