Revista Farmespaña Industrial Mayo Junio 2026

Panorama regulatorio internacional , 6# -/%)2>)/# *27'6")/*$/# $%)2*%"-$/%"6# ($7'2#28/6'-$/%"%&/#F"-$"#'%#,/&20 6/# H'2# -/,5$%"# &/(# +'2*;"(# "3"*2%0 )2,2%)2# /3'2()"(<# L/*# '%# 6"&/?# 2>$()2# '%"# 3*2($4%# -*2-$2%)2# 3"*"# "-262*"*# 26# "--2(/# "# %'28/(# )*")",$2%)/(# :# *2&'-$*# -"*7"(# "&,$0 %$()*")$8"(<#L/*#/)*/#6"&/?#6"(#"72%-$"(#*2+'2*0 ;"%#26#-/%)*/6#2%#G*2"(#&/%&2#32*-$52%#*$2(0 7/(#2()*'-)'*"62(?#2(32-$"6,2%)2#2%#-"6$&"&?# +"5*$-"-$4%#:#('32*8$($4%#&26#,2*-"&/< _,<$B;` !"(# %/)$-$"(# *2-$2%)2(# 3*/-2&2%)2(# &2# =()"0 &/(#n%$&/(?#='*/3"#:#M($"0L"-9+$-/#,'2()*"%# H'2#2()"# )2%($4%#%/#2(#3'%)'"6?#($%/#2()*'-0 )'*"6<# !/(# *27'6"&/*2(# 2()G%# "N'()"%&/# ('(# ,"*-/(# 3"*"# *2(3/%&2*# "# 3*/&'-)/(# ,G(# -/,362N/(?# -"&2%"(# &2# (',$%$()*/# 76/5"62(# :#'%"#$%%/8"-$4%#-$2%)9+$-"#H'2#:"#%/#2%-"N"# 2%#,/&26/(#)*"&$-$/%"62(< L"*"#6/(#3*/+2($/%"62(#&2#*27'6")/*:#"{"$*(?# 26#*2)/#%/#2(#(/6/#(27'$*#6/(#-",5$/(?#($%/#2%0 )2%&2*#F"-$"#&4%&2#(2#&$*$72#26#($()2,"#2%#('# -/%N'%)/< #*%+B;*"D$)B;* =%#=()"&/(#n%$&/(?#6"#"-)$8$&"&#*2-$2%)2#&2# 6"#CkM#*2+62N"#'%"#"72%-$"#H'2#2()G#3*/5"%0 &/# %'28"(# F2**",$2%)"(# 3"*"# 7"%"*# 826/0 -$&"&?# "'%H'2# ($%# *2%'%-$"*# "# ('# 3"326# &2# -/%)*/6< n%/#&2#6/(#262,2%)/(#,G(#8$($562(#2(#26#&20 ("**/66/#&26#Q/,,$(($/%2*R(#m")$/%"6#L*$/*$):# Z/'-F2*# L*/7*",<# =()2# 3*/7*","# 32*,$)2# "-262*"*#6"#*28$($4%#&2#&2)2*,$%"&/(#3*/&'-0 )/(#-/%($&2*"&/(#2()*").7$-/(<#=%#6"(#16)$,"(# (2,"%"(?# 6"# Ck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k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m/# (2# )*")"# &2# '%# )2,"# 3'%)'"6?# ($%/# &2# '%"#69%2"#&2#8$7$6"%-$"#H'2#6628"#"D/(#28/0 6'-$/%"%&/#:#H'2#-/%)$%1"#",36$G%&/(2#"# %'28/(#)$3/(#&2#3*/&'-)/(< W)*/# 2N2# $,3/*)"%)2# 2(# 6"# *2&'--$4%# &26# '(/# &2# "%$,"62(# 2%# $%82()$7"-$4%<# !"# CkM# F"# *2+/*;"&/#('#2()*")27$"#2%#2()2#G,5$)/?# 3*/,/8$2%&/#,.)/&/(#"6)2*%")$8/(?#F2**"0 ,$2%)"(# &$7$)"62(# :# 26# '(/# &2# $%)26$72%-$"# "*)$+$-$"6<# =()2# -",5$/# %/# (/6/# *2(3/%&2# "# -/%($&2*"-$/%2(# .)$-"(?# ($%/# )",5$.%# "# 6"# 51(H'2&"# &2# ,/&26/(# ,G(# 3*2&$-)$8/(# :# 2+$-$2%)2(< =%# 26# G,5$)/# &2# &$(3/($)$8/(# :# (/+)w"*2?# 6"#"72%-$"#F"#,/()*"&/#'%"#3/($-$4%#,G(# -/%(2*8"&/*"<# =6# *2-F";/# "# -$2*)"(# 3*/0 3'2()"(# 3"*"# +62>$5$6$;"*# 6"# *27'6"-$4%# &2# (/+)w"*2#,.&$-/#$%&$-"#H'2?#32(2#"#6"#3*20 ($4%#&26#(2-)/*?#6"#Ck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n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n este espacio analizamos los principales cambios regulatorios que afectan al desarrollo, fabricación y comercialización de productos sanitarios, farmacéuticos y biotecnológicos. El objetivo es ofrecer una visión práctica de las tendencias regulatorias que están definiendo el entorno del sector a nivel internacional. La sección está elaborada por Andrés Gola Isasi , Consultant & Project Manager PBSV (PharmaBioServ) 42 FARMESPAÑA INDUSTRIAL · MAY/JUN 26 farmaindustrial regulatorY neWs