Over the last decade, 2007-2016, convergence in approval times as well as changes in strategies of multinational pharmaceutical companies have resulted in more new active substances (NASs) being internationalised, referring here to receiving marketing authorisation in 6 major regulatory agencies, namely the European Medicines Agency (EMA), the US Food and Drug Authority (FDA), the Japan Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Swissmedic and the Australian Therapeutic Goods Administration (TGA). More specifically, the number of products approved by all the six agencies increased from 4 NASs in 2011-2012 to 13 NASs in 2015-2016.
High-unmet need was seen as one of the key drivers for internationalisation. A greater proportion of anti-cancer and immunomodulating NASs and, in particular, products given a Breakthrough Designation by FDA, obtained marketing authorisation in the six agencies compared with the rest of NASs. The size of sponsor also had an effect; companies with large R&D budgets (>3 billion USD) were more likely to internationalise their products and also submitted to the six agencies earlier. Such integration of worldwide drug development and registration by companies, as well as more efficient reviews within agencies, enable NASs to be made available to wider patient populations globally in a timely manner.