Pharmaceutical regulations vary widely in different countries, though new research published Friday 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 (the authors from the European Center of Pharmaceutical Medicine and Novo Nordisk point to the US, Europe and Japan as being the regulators in such markets), the US Food and Drug Administration (FDA) has the most internal reviewers (about 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 in China, prior to August 2015, China Food and Drug Administration (CFDA) had only about 120 staff in its Center of Drug Evaluation to perform scientific evaluations, though the research says the State Council of China has since brought that number up to about 300 to clear 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, US FDA was noted as approving the most NDAs for new drugs (45) in 2015, though Japan’s PMDA approved the most NDAs (48) in 2016.
Similarly, timelines to NDA approval have different definitions and processes, though the researchers said the shortest time to market was 210 calendar days for EMA and the longest was 900 calendar days for CFDA (though CFDA is trying to accelerate that process).
NDA review fees also vary, the authors reported, noting India had the lowest fees (50,000 Indian rupees; ~$1,000), whereas FDA had the highest ($2.3 million).
"Overall, the regulatory authorities in developed countries such as the United States, European Union, UK, Canada and Japan are more evolved in terms of regulatory systems and resources, such as technical reviewers, but have higher NDA fees," the authors wrote.
Nature Reviews Drug Discovery