WHO collaborative registration procedure using stringent regulatory authorities’ medicine evaluation: reliance in action?

Figures & data

Table 1. List of SRA CRP submissions and approvals (as of June 2021)

SRA	Medicines (INN)	Dosage and Pharmaceutical form	Therapeutic class (ATC/DDD Index)	Indication	Submissions n (%)	Approvals (n)	Applicant/ Manufacturer
EMA	etravirine	25 mg Dispersible tablets	Antivirals for systemic use	Treatment of HIV/AIDS	13(15)	11	Janssen Cilag International
EMA	darunavir	400 mg Tablets	Antivirals for systemic use	Treatment of HIV/AIDS	5(6)	4	Janssen Cilag International
EMA	darunavir	100 mg/ml Oral suspension	Antivirals for systemic use	Treatment of HIV/AIDS	4(5)	4	Janssen Cilag International
EMA	bedaquiline	100 mg Tablets	Anti-infective for systemic use	Treatment of tuberculosis	11(13)	5	Janssen Cilag International
MHRA	medroxyprogesterone acetate	104 mg/0.65 mL Suspension for injection	Sex hormones and modulators of the genital system	Long-term female contraception	17(20)	12	Pfizer Ltd
EMA (EU-M4all)	pyronaridine/artesunate	180 mg/60 mg Film-coated tablets	Antimalarials	Treatment of malaria	4(5)	4	Shin Poong Pharmaceutical Co., Ltd
EMA (EU-M4all)	pyronaridine/artesunate	60 mg/20 mg Granules for oral suspension	Antimalarials	Treatment of malaria	9(10)	5	Shin Poong Pharmaceutical Co., Ltd
EMA	piperaquine tetraphosphate/Artenimol (dihydroartemisinin)	160 mg/20 mg Film-coated tablets	Antimalarials	Treatment of malaria	1(1)	1	Alfasigma S.p.A, Italy
EMA	piperaquine tetraphosphate/Artenimol (dihydroartemisinin)	320 mg/40 mg Film-coated tablets	Antimalarials	Treatment of malaria	1(1)	1	Alfasigma S.p.A, Italy
EMA (EU-M4all)	dapivirine	25 mg Vaginal ring	Gynecological anti-infective and antiseptics	Prevention from HIV/AIDS	8(9)	0	IPM (International Partnership for Microbicides)
EMA	emicizumab	30/1 ml solution for injection	Antihemorrhagics	Prevention/ reduction of bleeding in patients with hemophilia A	3(3)	3	A F. Hoffmann–La Roche AG
EMA	emicizumab	60/0,4 ml solution for injection	Antihemorrhagics	Prevention/ reduction of bleeding in patients with hemophilia A	3(3)	3	A F. Hoffmann–La Roche AG
EMA	emicizumab	105/0,7 ml solution for injection	Antihemorrhagics	Prevention/ reduction of bleeding in patients with hemophilia A	3(3)	3	A F. Hoffmann–La Roche AG
EMA	emicizumab	150/1 ml solution for injection	Antihemorrhagics	Prevention/ reduction of bleeding in patients with hemophilia A	3(3)	3	A F. Hoffmann–La Roche AG
MHRA	methadone hydrochloride	10 mg oral solution	Analgesics	Substitution therapy for maintenance of opioid dependence	1(1)	0	Alkaloid AD Skopje
EMA	pneumococcal polysaccharide	conjugate vaccine (13-valent, adsorbed)	Bacterial Vaccines	Prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae	2(2)	0	Pfizer Ltd
Total					88	59

Figure 1. Geographic distribution of the SRA CRP approvals.

Figure 2. Regulatory approvals per therapeutic indication (n = 59).