Study Released on Comparison of International Regulatory Authorities

  Pharmaceutical regulations vary widely across the world, and while our sister publication, Life Science Compliance Update, keeps compliance professionals abreast of new development and comparisons across continents and countries, an article published August 2017 in Nature Reviews Drug Discovery offers comparisons in terms of the regulators’ budgets, staff, new drug approvals and timelines for approvals.   Of the regulators in the more established major pharmaceutical markets (in this study, the United States, Europe and Japan are considered the regulators in such markets), the United States Food and Drug Administration (FDA) has the most internal reviewers (an estimated 2,000), though the European Medicines Agency (EMA) has a network of more than 4,500 experts providing scientific expertise to the agency.   Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), meanwhile, has about 560 reviewers, while the China Food and Drug Administration (CFDA) had only about 120 staff in its Center of Drug Evaluation to perform scientific evaluations through August 2015. Since August 2015, the research says the State Council of China has brought that number up to about 300 to work through a backlog of applications.    As far as new drug application (NDA) submissions and approvals, differing NDA definitions or their equivalents between authorities make direct comparisons difficult, though in the established markets, the FDA was not...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs