Major improvements in the regulatory environment as well as changes in strategies of multinational companies have led to a decrease in the time to marketing authorisation as well as an increase in the number of medicines that have become available over the last decade, 2008-2017, across six major regulatory agencies, namely the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), the Japan Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Swissmedic and the Australian Therapeutic Goods Administration (TGA). More specifically, the number of common products approved by all six agencies increased from 12 in 2008-2012 to 51 in 2013-2017.

Underlying factors influencing the overall time it takes for a new medicine to be submitted and then approved by an agency include company strategy, the conduct and the type of the review process, the type of the product and its therapeutic area; these aspects are analysed and discussed in this study. Nevertheless, one of the key factors that may determine the likelihood and timing of submission is the size of the sponsor, which will be a focus of this Briefing, where a medicine may be less likely to become internationalised beyond the first country of submission if it is developed by a smaller company.