Table 1.
Median approval times: The reported median approval times from various regulatory authorities between 2013 and 2019
| Authority, years | Country | Median approval times (calendar days) | Number of applications |
|---|---|---|---|
| US Food and Drug Administration, 2017–2019 | USA | 247 | 48 |
| Health Canada, 2015–2019 | Canada | 347 | 30 |
| Australian Therapeutic Goods Administration (TGA), 2015–2019 | Australia | 351 | 25 |
| European Medicines Agency (EMA), 2015–2019 | European countries | 433 | 27 |
| Swiss Medic, 2015–2019 | Switzerland | 527 | 28 |
| Agência Nacional de Vigilância Sanitária (ANVISA), 2013–2016 | Brazil | 795 | 138 |
| South African Health Products Regulatory Authority (SAHPRA), 2015–2018 | South Africa | 1622 | 121 |