Table 1.

Failure rate per country in quality surveys, bioequivalence studies, accelerated biostability studies, laboratory assembled collections and case reports/MRA seizures

Countries	Accelerated biostability studies			Bioequivalence studies			Quality surveys			Laboratory assembled collections			MRA seizure			Total
	N	n	Failure rate %	N	n	Failure rate %	N	n	Failure rate %	N	n	Failure rate %	N	n	Failure rate %	No of data points	N	n failed	Failure rate %
Africa				627	65	10.4	122	33	27							45	749	98	13.1
Botswana							13	4	30.8							3	13	4	30.8
Kenya							42	5	11.9							20	42	5	11.9
Nigeria				9	5	55.6	50	22	44.0							6	59	27	45.8
South Africa				618	60	9.7										13	618	60	9.7
Zambia							17	2	11.8							3	17	2	11.8
Americas	18	0	0.0	18	18	100.0	18	0	0.0							5	54	18	33.3
Mexico				18	18	100.0	18	0	0.0							2	36	18	50.0
USA	18	0	0.0													3	18	0	0.0
Asia	218	87	39.9	436	53	12.2	5082	732	14	20	1	5.0	2	2	100.0	145	5758	875	15.2
Armenia							42	4	9.5							5	42	4	9.5
Azerbaijan							31	3	9.7							5	31	3	9.7
Cambodia							117	31	26.5							2	117	31	26.5
India	206	87	42.2	362	6	1.7	3484	377	10.8	12	0	0.0	2	2	100.0	92	4066	472	11.6
Indonesia				74	47	63.5	71	4	5.6							4	145	51	35.2
Kazakhstan							842	176	20.9							16	842	176	20.9
Myanmar/Burma							13	1	7.7							1	13	1	7.7
Pakistan										8	1	12.5				2	8	1	12.5
Thailand	12	0	0.0				198	50	25.3							5	210	50	23.8
Uzbekistan							45	6	13.3							5	45	6	13.3
Vietnam							239	80	33.5							8	239	80	33.5
Europe				5	0	0.0	113	6	5.3	18	0	0				16	136	6	4.41
Republic of Belarus							60	4	6.7							5	60	4	6.7
Switzerland										4	0	0.0				1	4	0	0.0
Ukraine							53	2	3.8							4	53	2	3.8
UK				5	0	0.0				14	0	0.0				6	19	0	0.0
Unstated							920	108	11.7				65	65	100.0	11	985	173	17.6
Total	236	87	36.9	1086	136	12.5	6255	879	14.1	38	1	2.6	67	67	100.0	222	7682	1170	15.2

MRA, Medicines Regulatory Agency.