Revista Farmespaña Industrial - Septiembre Octubre 2026

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b)$/#A-:')/#*%#"&)'D'*"*#%5#7"#*';')"7'M"&'+(# *%# 7"# $%*# $%;07")/$'"?# !"# HPQ# <# 7/5# e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`%'(/#g('*/9#7"#Pe`Q#4"#"&7"$"*/#"*%> -A5# &+-/# *%:%(# ;%5)'/("$5%# 7/5# 5PNT\OTQ% ,M[Pb^% &_OMbP% :P_\NbZ% n5,&:o # &0"(*/# 0("# 505)"(&'"# "&)'D"# *%5"6"$%&%# *%# 7"# 7'5)"# %0$/6%"# *%# .%&4"5# *%# $%.%$%(&'"?# !/5# )')07"> $%5# *%:%$A(# &/()'(0"$# "67'&"(*/# 7"# u7)'-"# .$%&0%(&'"# %5)":7%&'*"# "()%5# *%# 50# $%)'$"*"# 5"7D/# G0%# 7"# "0)/$'> *"*# :$')A('&"# '(*'G0%# %F6$%5"-%()%# /)$/# &"7%(*"$'/?#!"#";%(&'"# )"-:'8(# 4"# *%.'('*/# 50# 6/5'&'+(# 5/:$%# 7/5# -%*'&"-%()/5# :"5"> */5# %(# -'&$/:'/-"9# "6/$)"(*/# -"</$# &7"> $'*"*# 5/:$%# %7# -"$&/# "67'&":7%# "# 6$/*0&)/5# *%5)'("*/5# "# 6$%D%('$# /# )$")"$# %(.%$-%*"*%5# -%*'"()%# 7"# -/*'.'&"> &'+(# /# 505)')0&'+(# *%7# -'&$/:'/-"#40-"(/? /*)+c=+8TG)89" 89IB)$+"+&I9$)P+8)H$"89$"I+M9&" 89$%&9@ Q05)$"7'"#&/()'(u"#6$/.0(*'M"(*/#%(#50#%5)$"> )%;'"# *%# "7'(%"-'%()/# '()%$("&'/("7?# !"# YcQ# "*/6)+#'('&'"7-%()%#1E#;0="5#&'%()=.'&"5#'()%$> ("&'/("7%5#6$/&%*%()%5#*%#/$;"('5-/5#&/-/# W@e9#HPQ#<#,VQ#<#6/5)%$'/$-%()%#6$/605/#'(> &/$6/$"$#/)$"5#NN?#H()$%#%5)"5#u7)'-"5#5%#'(&70> <%(# */&0-%()/5# $%7"&'/("*/5# &/(# :'/5'-'> 7"$%59# '(-0(/;%('&'*"*9# D"&0("59# 6$/*0&)/5# '(4"7"*/5# <# D"7'*"&'+(# *%# 6$/&%5/59# "*%-A5# *%#(0%D"5#;0="5#W@e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a$+"I9F'&$)P+8)H$"89$"'@"G989";>'*%9" '$"'@"89$%&9@ !"5#'('&'")'D"5#*%#7"5#6$'(&'6"7%5#"0)/$'*"*%5# -0%5)$"(# 0("# ";%(*"# $%;07")/$'"# %56%&'"7> -%()%# "&)'D"# %(# .":$'&"&'+(9# '(56%&&'/(%59# *")/5# <# "$-/('M"&'+(?# ,VQ# %5)A# $%D'5"(*/# 5'-07)A(%"-%()%# 50# %5)$0&)0$"# '(56%&)/$"9# 505# 6$/;$"-"5# *%# )"5"5# <# 505# -%&"('5-/5# *%# '()%$"&&'+(#&/(# 7"# '(*05)$'"x#H0$/6"#&/(> )'(u"# "*"6)"(*/# $%G0'5')/5# &'%()=.'&/5# <# &/(5)$0<%(*/# 0("# '(.$"%5)$0&)0$"# $%;07")/> $'"#:"5"*"#%(#*")/5x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ñ La actividad regulatoria internacional continúa mostrando un esfuerzo por modernizar los procedimientos sin reducir las expectativas sobre calidad y cumplimiento. 35 FARMESPAÑA INDUSTRIAL · SEP/OCT 26 farmaiNdustrial GloBal reGulatorY NeWs