Table 2.

Association of characteristics of EML applications leading to negative recommendations between 2002 and 2023 (univariate and multivariate logistic regression).

	Applications submitted (N = 359)	Negative recommendations (N = 148)	Negative/total	Univariate OR (95% CI)	Multivariate OR (95% CI)
List
EML	222	95	0.43	1.00	1.00
EML&EMLc	106	36	0.34	0.69 (0.42–1.11)	0.62 (0.35–1.04)
EMLc	31	17	0.55	1.62 (0.76–3.46)	1.88 (0.81–4.35)
Listing
Core	216	81	0.38	1.00	1.00
Complementary	134	62	0.46	1.43 (0.93–2.22)	1.93 (1.11–3.36)
Core & Complementary	9	5	0.56	2.08 (0.54–8.00)	3.28 (0.75–14.29)
Therapeutic group
Communicable	134	46	0.34	1.00	1.00
Noncommunicable	225	102	0. < 45	0.63 (0.40–0.98)	0.70 (0.37–1.30)
Active substance
Chemical	308	120	0.39	1.00	1.00
Biological	51	28	0.55	1.91 (1.05–3.46)	1.94 (0.94–3.98)
Orphan designation
No	291	129	0.44	1.00	1.00
Yes	68	19	0.28	0.49 (0.27–0.87)	0.28 (0.14–0.55)
Single applicant
WHO	77	21	0.27	1.00	1.00
Non-profit organization	99	37	0.37	1.59 (0.83–3.04)	1.13 (0.52–2.45)
Pharmaceutical company	62	36	0.58	3.69 (1.81–7.52)	4.00 (1.88–8.55)
Academia	36	19	0.53	2.98 (1.31–6.80)	2.31 (0.89–6.06)
Healthcare institution	10	3	0.30	1.14 (0.27–4.83)	0.90 (0.19–4.35)
WHO Collaborating Center	17	4	0.24	0.82 (0.24–2.80)	0.54 (0.14–2.16)
Individual	19	12	0.63	4.57 (1.59–13.16)	3.37 (1.02–11.11)
Multiple applicants	33	14	0.42	1.96 (0.84–4.61)	2.05 (0.78–5.38)
NA	6	2	0.33	1.33 (0.23–7.81)	0.81 (0.12–5.41)

Bold values indicates statistical significance.