ANNEXES
IV. REGULATORY ENVIRONMENT FOR TB MEDICINES REGULATORY ENVIRONMENT FOR TB MEDICINES: ACCORDING TO NATIONAL POLICY
Unregistered TB drugs are available through compassionate use/other legal mechanisms**
If YES, which one of these mechanisms is in place?
National Essential Medicines List (nEML) reflects WHO recommendations***
Yes, except for Lfx, Gfx
Afghanistan vi
Armenia Bangladesh
Yes, except for Gfx
vi
No Yes, except for Mfx, Gfx
Belarus Brazil
Yes, except for Gfx
Cambodia
Yes
CAR
No
China
Yes, except for Gfx
DRC
Yes, except for Gfx
Ethiopia
Waiver
Georgia
Compassionate use, regular import procedure, exemption mechanisms, importation for unregistered drugs, under programmatic use
Yes, except for Gfx vii
India
Kazakhstan
NA
vii
Yes, except for Gfx
Indonesia
No
?
Yes, except for Gfx
Kenya
Yes, except for Gfx
Kyrgyzstan
viii
No
Mozambique
ix
Yes, except for Gfx
Myanmar
viii
Nigeria
No
Pakistan
Yes, except for Mfx, Gfx
PNG
Yes, except for Mfx, Gfx
Philippines
Yes, except for Mfx, Gfx
Russian Fed.
No
South Africa
Yes, except for Lfx, Gfx
Tajikistan
Yes, except for Gfx Humanitarian access channel
Yes, except for Gfx
Ukraine Viet Nam Zimbabwe
ix
Yes, except for Gfx
Swaziland
74
Group A medicines are on the nEML***
Yes, except for Gfx Research framework and Expanded Access Program
Yes, except for Mfx, Gfx x
Yes, except for Gfx
x
(**) Compassionate use, expanded access programmes, import waivers or other legal mechanisms. (***) Group A: levofloxacin (Lfx), moxifloxacin (Mfx), gatifloxacin (Gfx) / Group B: amikacin (Am), capreomycin (Cm), kanamycin (Km), (streptomycin, S) / Group C: ethionamide (Eto) (or prothionamide, Pto), cycloserine (Cs) (or terizidone, Trd), linezolid (Lzd), clofazimine (Cfz) / Group D1: pyrazinamide (Z), ethambutol (E), high-dose isoniazid (Hh) / Group D2: bedaquiline (Bdq), delamanid (Dlm) / Group D3: p-aminosalicylic acid (PAS), imipenem-cilastatin (Ipm/Cln), meropenem (Mpm), amoxicillin-clavulanate (Amx-Clv), (thioacetazone, T). (Notes: streptomycin is part of the category II retreatment regimen, which should no longer be prescribed according to WHO’s latest recommendations (May 2017); only medicines listed in anti-TB sections of nEMLs are listed as YES)