Table 2.

Number of Products Submitted to and Approved by ANVISA by Product Type, 2013–2016 (N = 235).

Compound Types	Products Approved 2016, n (% of Total)	Products Submitted 2013, n (% of Total)	Products Submitted 2014, n (% of Total)	Products Submitted 2015, n (% of Total)	Products Submitted 2016, n (% of Total)	Products Submitted 2013–2016, n (% of Total)
Generics	90 (65%)	106 (88%)	24 (50%)	26 (54%)	8 (44%)	164 (70%)
New active substances	20 (14%)	5 (4%)	11 (23%)	12 (25%)	2 (11%)	30 (13%)
Biologics	19 (14%)	1 (0.8%)	10 (21%)	6 (13%)	8 (44%)	25 (11%)
Major line extensions	9 (7%)	9 (7%)	3 (6%)	4 (8%)	0	16 (7%)
Totals	138	121	48	48	18	235