Estándares internacionales sobre la calidad, seguridad y eficacia de los medicamentos

AutorXavier Seuba Hernández
Páginas115-151
&$3Ë78/2,,,
ESTÁNDARES INTERNACIONALES SOBRE
LA CALIDAD, SEGURIDAD Y EFICACIA
DE LOS MEDICAMENTOS
I. LA CALIDAD, SEGURIDAD Y EFICACIA
DE LOS FÁRMACOS
(QWUHORVSULPHURVREMHWLYRVGHODFRRSHUDFLyQLQWHUQDFLRQDOHQPD
WHULDGHVDOXG\'HUHFKRHVWXYR\DHQHOVLJOR;,;HOGHHVWDEOHFHUFLHU
WRVHVWiQGDUHVXQLIFDGRVUHODWLYRVDORVSURGXFWRVIDUPDFpXWLFRV'HVGH
HQWRQFHVOD JDUDQWtDGH ODFDOLGDGVHJXULGDG \HIFDFLDGHORV PHGLFD
PHQWRVKDVLGRXQDSUHRFXSDFLyQLQWHUQDFLRQDOFRQVWDQWH6HWUDWDGHXQD
WHPiWLFDFX\DJHVWLyQHQHOSODQRJOREDOVHKDSUHIHULGRGHMDUHQPDQRV
GHFRPLWpV GH H[SHUWRVGH OD 206\ RUJDQL]DFLRQHV GHQXHYR FXxR \
QRDGRSWDUHQFDPELRWUDWDGRVLQWHUQDFLRQDOHVPXOWLODWHUDOHVGHDOFDQFH
XQLYHUVDOXRWURWLSRGHWH[WRVTXHHVWDEOH]FDQREOLJDFLRQHVYLQFXODQWHV
 /$&$/,'$'6(*85,'$'<(),&$&,$'(/26
0(',&$0(1726(13(563(&7,9$,17(51$&,21$/
A. La calidad, seguridad y e cacia de los medicamentos
*DUDQWL]DUOD FDOLGDG VHJXULGDG\HIFDFLD GH ORVPHGLFDPHQWRV HV
IXQGDPHQWDOSDUDSUHVHUYDUODVDOXGLQGLYLGXDO\ ODVDOXGS~EOLFD3DUD
 /DGHIFLHQWHFDOLGDGSURYRFDLQWR[LFDFLRQHV\QRVDWLVIDFHHOHIHFWRWHUDSpXWLFRSUHWHQGLGR
\SXHGHLQFOXVRFDXVDUODPXHUWH$VLPLVPROD PDODFDOLGDGFRPSURPHWHODVDOXGS~EOLFDDO RUL
Ů
 ;$9,(56(8%$+(51È1'(=
GHPRVWUDUODFDOLGDGGHOIiUPDFRVHGHEHDSRUWDUODFRUUHVSRQGLHQWHGRFX
PHQWDFLyQFOtQLFDIDUPDFpXWLFD\ELROyJLFD3DUDGHPRVWUDUODHIFDFLD
VHSUHVHQWDOD GRFXPHQWDFLyQFOtQLFDTXHDWHVWLJXD ORVHIHFWRVSUHWHQGL
GRVSDUDGHPRVWUDUODVHJXULGDGVHGHEHDFUHGLWDUHOFXPSOLPLHQWRGH
ORVHVWiQGDUHVIDUPDFRSpLFRV \DSRUWDUORVUHVXOWDGRVGH ODVSUXHEDVGH
HVWDELOLGDGGHORVHQVD\RVFOtQLFRVGHODVSUXHEDVGHWR[LFLGDG\IDUPD
FROyJLFDVVREUHDQLPDOHV\ODLQIRUPDFLyQVREUHUHDFFLRQHVDGYHUVDV
(QHVWH FRQWH[WR VH GLVWLQJXHQ GRVJUDQGHVFRQFHSWRV HO GH ©FRQ
WUROGH FDOLGDGª\ HOGH©JDUDQWtD GHFDOLGDGª(O FRQWUROGH FDOLGDGVH
UHIHUHDODYHULIFDFLyQGHOD FDOLGDGGHO SURGXFWRWHUPLQDGR\DEDUFD
SURFHVRVRUJDQL]DFLyQ\GRFXPHQWDFLyQ \VXHOHUHDOL]DUVHDOUHJLVWUDU
HOIiUPDFR3RURWURODGRHOFRQFHSWRGH©JDUDQWtD GHFDOLGDGªHV PiV
FRPSUHKHQVLYRSXHVWRTXHHVWiLPEXLGRHQHOPHGLFDPHQWR\DOXGHDOD
FDOLGDGGHO IiUPDFRGHVGHVX IDEULFDFLyQKDVWDVX XVR/D JDUDQWtD GH
FDOLGDGFRPSUHQGHWRGRVORVSUHSDUDWLYRV\SURFHVRV TXHDVHJXUDQ TXH
VHVDWLVIDFHODFDOLGDGUHTXHULGDSDUDHOXVRSUHWHQGLGR3DUDHOORVHOOH
YDQDFDERWUHVDFWLYLGDGHVTXHDVXYH]DEDUFDQRWUDVPXFKDVHODQiOLVLV
GHOPHGLFDPHQWRVXUHJLVWUR\HOFRQWUROHLQVSHFFLyQGHODVSUiFWLFDVGH
PDQXIDFWXUDFLyQ
0HGLDQWHHODQiOLVLVGHORVPHGLFDPHQWRVVHFRPSUXHEDVXLGHQWLGDG
SRWHQFLDSXUH]DXQLIRUPLGDGELRGLVSRQLELOLGDG\ HVWDELOLGDGFDUDFWH
UtVWLFDVTXHUHFRJHQODV IDUPDFRSHDV 3RU RWUR ODGR HO UHJLVWUR FRQGL
FLRQDODFRPHUFLDOL]DFLyQGHORVIiUPDFRVSDUDODTXHVHGHEHDFUHGLWDU
ODHIFDFLD²QRUPDOPHQWH HQUHODFLyQFRQ XQ SODFHER² VHJXULGDG \
FDOLGDGGHOPHGLFDPHQWRDVtFRPRODVFRQGLFLRQHVGHFRPHUFLDOL]DFLyQ
6H WUDWD GH XQ DQiOLVLV JOREDO TXH UHTXLHUH XQ SHULRGR GH WLHPSR TXH
VXHOHRVFLODUHQWUHWUHV\ VHLVDxRV (QIXQFLyQ GHOWLSRGHSURGXFWRVX
IDEULFDFLyQVHGHQRPLQD©SULPDULDªR©VHFXQGDULDª\ HQDPERVFDVRV
ULJHQODV©EXHQDVSUiFWLFDVGHPDQXIDFWXUDFLyQªHVGHFLUORVHVWiQGDUHV
JLQDULQWR[LFDFLRQHVPDVLYDV\PiVDODUJRSOD]RODDSDULFLyQGHIDUPDFRUUHVLVWHQFLD\ODPHUPD
GHFRQIDQ]D HQ HOVLVWHPD VDQLWDULR 206 Por una reglamentación farmacéutica e caz como
garantía de seguridad, e cacia y calidad,3HUVSHFWLYDVSROtWLFDVGHOD206VREUH PHGLFDPHQWRV
Q~P*LQHEUD206S
 :+2Marketing Authorization of Pharmaceutical Products with Special Reference to Mul-
tisource (Generic) Products. A manual for a Drug Regulatory Authority,*HQHYD:+2S
 . :,('(10$©0HGLFLQH TXDOLW\ DGYHUVHUHDFWLRQV DQG DQWLPLFURELDO UHVLVWDQFHªHQ
6$'(5621 et al.,Managing Pharmaceutical in International Health%DVHO%RVWRQ%HUOLQ%LUNKDX
VHU9HUODJS
 :+2 Health Technology and Pharmaceuticals. 2000-2003 Strategy, *HQHYD :+2
:+2+73S
 6LELHQ HVWDVDFWLYLGDGHVVRQ LPSRUWDQWHVHQFDVR GHHVFDVH]GH UHFXUVRVODSULRULGDG HV
HOUHJLVWURGHIiUPDFRV SURFHGLpQGRVHVyOROXHJRD ODLQVSHFFLyQ\DO H[DPHQ.:,('(10$
op. citS
 /D©SULPDULDªLPSOLFDSURFHVDUPDWHULDOHVEiVLFRVSDUDFRQVHJXLULQJUHGLHQWHVDFWLYRVKD
ELWXDOPHQWHXQD HQWLGDG TXtPLFD FRPSOHMDPLHQWUDV TXH OD©VHFXQGDULDª VH OLPLWD DFRPELQDU
H[FLSLHQWHV\SULQFLSLRVDFWLYRVSDUDUHDOL]DUHOSURGXFWRIQDO
Ů
(67È1'$5(6,17(51$&,21$/(662%5(/$&$/,'$'6(*85,'$' 
UHODWLYRVD ODVLQVWDODFLRQHV SHUVRQDV\SUiFWLFDV TXHLQWHUYLHQHQ HQOD
IDEULFDFLyQTXHVHFRPSOHPHQWDQFRQODLQVSHFFLyQ
(OWpUPLQR©PHGLFDPHQWRVXEHVWiQGDUªGHVLJQDDXQ SURGXFWRFX\D
FRPSRVLFLyQHLQJUHGLHQWHVQRFRQFXHUGDQFRQODVHVSHFLIFDFLRQHVFLHQ
WtIFDVFRUUHFWDV\TXHHQFRQVHFXHQFLDSXHGHVHULQHIHFWLYR\SHOLJUR
VR'HQWURGH HVWDDPSOLDFDWHJRUtDVHVXHOHLQFOXLUORV IiUPDFRVIDOVL
IFDGRVHVGHFLUSURGXFWRVFRPHUFLDOL]DGRVIUDXGXOHQWDPHQWHDOPHQWLU
FRQUHVSHFWRDVXRULJHQ6HWUDWDGHIiUPDFRVTXHVXHOHQLPSOLFDUXQD
YLRODFLyQGHXQGHUHFKRGHPDUFDVLELHQQRVLHPSUHVRQVXEHVWiQGDU$
SHVDUGHDODPD\RUDWHQFLyQGHGLFDGDDORVPHGLFDPHQWRVIDOVLIFDGRV
HQWpUPLQRVGH VDOXG S~EOLFD VRQ PXFKR PiV SUHRFXSDQWHV ODV FRQVH
FXHQFLDVGH IiUPDFRVVXEHVWiQGDU TXHQR QHFHVDULDPHQWHVRQIDOVLIFD
GRV
'XUDQWHORVHQVD\RVFOtQLFRVHOPHGLFDPHQWRVHSUXHEDFRPRPi[L
PRFRQXQRVFLHQWRVGHSHUVRQDVGHPRGRTXHVXVHJXULGDGVRODPHQWH
VHFRQRFH SOHQDPHQWH FXDQGR HO IiUPDFR VHFRPHUFLDOL]D3RU HOOR D
SHVDUGHTXHVHGHPXHVWUHLQLFLDOPHQWHODFDOLGDGVHJXULGDG\HIFDFLD
SXHGHQSURGXFLUVH HIHFWRV VHFXQGDULRV\ UHDFFLRQHV DGYHUVDVHVGHFLU
SUREOHPDVFRQ ODVHJXULGDG GHOIiUPDFR /DQHFHVLGDGGHFRQWURODUODV
UHDFFLRQHVDGYHUVDV\ORVSUREOHPDVGHVHJXULGDGGHORVIiUPDFRVKD
GDGROXJDUDODIDUPDFRYLJLODQFLDTXHFRPSUHQGLGD HQODIDUPDFRORJtD
FOtQLFDHV OD FLHQFLD \ODVDFWLYLGDGHV UHODFLRQDGDV FRQ OD GHWHFFLyQ
HYDOXDFLyQFRPSUHQVLyQ\SUHYHQFLyQGH ODVUHDFFLRQHV DGYHUVDV\ORV
HIHFWRVVHFXQGDULRVGHORVIiUPDFRV
B. Situación farmacéutica mundial en materia de calidad,
seguridad y e cacia
/DLQIRUPDFLyQVREUHODVHJXULGDGHIFDFLD\FDOLGDGGHORVPHGLFD
PHQWRVVH REWLHQH PHGLDQWHFRVWRVDVSUXHEDV GHODERUDWRULR\ HQVD\RV
FOtQLFRVVREUHDQLPDOHV\SHUVRQDV/DUHJXODFLyQGHGLFKDLQIRUPDFLyQ
\HQVD\RVVXHOHGLIHULUHQFDGDSDtVSRUORTXHKDVWDIHFKDVUHFLHQWHVODV
 :+2 ©&RPEDWLQJ FRXQWHUIHLW PHGLFLQHVª WHO Drug Information, YRO Q~P
S
 -0&$8'521 et al. ©6XEVWDQGDUGPHGLFLQHV LQ UHVRXUFHSRRUVHWWLQJV D SUREOHPWKDW
FDQQR ORQJHUEH LJQRUHGª Tropical Medicine and International HealthYRO Q~P 
S
 'HKHFKRQLQJ~QIiUPDFRHVFRPSOHWDPHQWHVHJXURSDUDWRGDV ODVSHUVRQDV\HQWRGDFLU
FXQVWDQFLD80&Viewpoint. Watching for safer Medicines. The scienti c and technical history.
Part 28SSVDOD80&:+2S
 )LJXUDQHQWUHODVGLH]SULPHUDVFDXVDVGHPRUWDOLGDGHQQXPHURVRVSDtVHV206La farma-
covigilancia: garantía de seguridad en el uso de los medicamentos 3HUVSHFWLYDVSROtWLFDV GHOD
206VREUHPHGLFDPHQWRVQ~P*LQHEUD206S
 -60,7+©8QIQLVKHGEXVLQHVVFOLQLFDOSKDUPDFRORJ\DQGZRUOGKHDOWKªWHO Drug In-
formationYROQ~PS
Ů

Para continuar leyendo

Solicita tu prueba

VLEX utiliza cookies de inicio de sesión para aportarte una mejor experiencia de navegación. Si haces click en 'Aceptar' o continúas navegando por esta web consideramos que aceptas nuestra política de cookies. ACEPTAR