FOOD AND DRUG ADMINISTRATION ( FDA )

Republic Act No. 9711, an act t!en"t#enin" an$ !ationali%in" t#e !e"ulato!& capacit& o' t#e
(u!eau o' Foo$ an$ D!u" b& etabli#in" a$e)uate tetin" labo!ato!ie an$ 'iel$ o''ice,
up"!a$in" it e)uip*ent, au"*entin" it #u*an !eou!ce co*ple*ent, "i+in" aut#o!it& to
!etain it inco*e, !ena*in" it t#e Foo$ an$ D!u" A$*init!ation (FDA), a*en$in" ce!tain
ection o' Republic Act No. ,7-., /a i"ne$ b& 0!ei$ent on Au"ut 11, -..9.
2ontent 3#o/4
Gene!al Function
De+elop plan policie, p!o"!a* an$ t!ate"ie 'o! !e"ulatin" p!ocee$ 'oo$, $!u"
an$ ot#e! !elate$ p!o$uct
Fo!*ulate !ule, !e"ulation an$ tan$a!$ 'o! licenin" an$ acc!e$itation o' p!ocee$
'oo$, $!u" an$ ot#e! !elate$ p!o$uct
2on$uct licenin" an$ acc!e$itation o' p!ocee$ 'oo$, $!u" an$ ot#e! !elate$
p!o$uct.
0!o+i$e tec#nical, conultati+e an$ a$+io!& e!+ice to an$ $e+elop capabilit& o' 'ile$
o''ice on licenin" an$ en'o!ce*ent o' la/, !ule an$ !e"ulation pe!tainin" to
p!ocee$ 'oo$, $!u" an$ ot#e! !elate$ p!o$uct.
Monito!, e+aluate an$ enu!e co*pliance o' *anu'actu!e!, $it!ibuto!, a$+e!tie!
an$ !etaile! o' p!ocee$ 'oo$, $!u" an$ ot#e! !elate$ p!o$uct to #ealt# !ule an$
!e"ulation an$ tan$a!$ o' )ualit&.
A$+ie t#e Sec!eta!& an$ Un$e!ec!eta!& o' 5ealt# on *atte! pe!tainin" to !e"ulation
o' p!ocee$ 'oo$, $!u" an$ ot#e! !elate$ p!o$uct.
0olic&, 0lannin" an$ A$+ocac& Di+iion
Speci'ic Function
De+elop plan, policie an$ p!o"!a* pe!tainin" to t#e !e"ulation o' p!ocee$ 'oo$,
$!u" an$ ot#e! !elate$ p!o$uct.
0!o+i$e tec#nical in'o!*ation an$ aitance to client an$ t#e "ene!al public on
*atte! pe!tainin" to 'oo$ an$ $!u" la/, !e"ulation, 'unction an$ e!+ice.
De+elop an$ *aintain a $atabae o' all licene$6acc!e$ite$ p!ocee$ 'oo$, $!u"
an$ ot#e! !elate$ p!o$uct.
0!o*ote !ational $!u" ue, el' !eliance an$ tailo!e$ p!ocu!e*ent an$ *onito! $!u"
p!ice pe! Gene!ic 7a/ an$ t#e 0#ilippine D!u" Fo!*ula!&
2on$uct p#a!*aco8epi$e*iolo"ical an$ p#a!*aco8econo*ic anal&i.
Re"ulation Di+iion I
Speci'ic Function
2on$uct inpection an$ iue licene 'o! t#e ope!ation o' etabli#*ent in+ol+e$ in
t#e i*po!tation, e9po!tation, $it!ibution an$ !etailin" o' p!ocee$ 'oo$, $!u", *e$ical
$e+ice, in +it!o !ea"ent, co*etic an$ #oue#ol$ #a%a!$ou ubtance
Monito! an$ enu!e )ualit& o' p!ocee$ 'oo$, $!u" an$ ot#e! !elate$ p!o$uct
t#!ou"# collection o' a*ple '!o* outlet an$ po!t o' ent!&.
:n'o!ce ei%u!e, con'ication an$ con$e*nation o!$e! co+e!in" p!o$uct +iolatin" 'oo$
an$ $!u" la/, !e"ulation an$ tan$a!$.
0!o+i$e tec#nical conultati+e an$ a$+io!& e!+ice an$ $e+elop capabilit& o' 'iel$
o''ice on licenin" an$ en'o!ce*ent o' !e"ulation inclu$in" *onito!in" i' a$+e!e $!u"
!eaction.
De+elop t#e tec#nical capabilit& o' Foo$ an$ D!u" !e"ulation O''ice! ai"ne$ at 'iel$
o''ice.
Re"ulation Di+iion II
Speci'ic Function
2on$uct inpection an$ iue licene 'o! t#e ope!ation o' etabli#*ent in+ol+e$ in
t#e *anu'actu!e an$ !e8pac;in" o' p!ocee$ 'oo$, $!u", *e$ical $e+ice, in +it!o
$ia"notic !ea"ent, co*etic an$ #oue#ol$ #a%a!$ou ubtance.
Monito! an$ enu!e co*pliance o' *anu'actu!e! /it# !e)ui!e*ent o' Goo$
Manu'actu!in" 0!actice (GM0).
:n'o!ce ei%u!e, con'ication an$ con$e*nation o!$e! co+e!in" p!o$uct +iolatin" 'oo$
an$ $!u" la/, !e"ulation an$ tan$a!$.
De+elop t#e tec#nical capabilit& o' Foo$ an$ D!u" Re"ulation O''ice! ai"ne$ at 'iel$
o''ice.
0!o$uct Se!+ice Di+iion Speci'ic Function
Fo!*ulate tan$a!$ an$ "ui$eline 'o! t#e !e"it!ation o' p!ocee$ 'oo$, $!u",
co*etic, *e$ical $e+ice, in +it!o $ia"notic !ea"ent an$ #oue#ol$ #a%a!$ou
ubtance.
:+aluate an$ p!ocee application an$ iue ce!ti'icate o' p!o$uct !e"it!ation an$
ce!ti'icate o' p!o$uct litin".
0!o+i$e aitance in t#e *onito!in" o' p!o$uct +iolatin" 'oo$ an$ $!u" la/,
!e"ulation an$tan$a!$.
7abo!ato!& Se!+ice Di+iion
Speci'ic Function
2on$uct labo!ato!& tet on 'ini#e$ p!o$uct to $ete!*ine co*pliance /it# tan$a!$ o'
a'et&, e''icac&, pu!it& an$ )ualit&.
2on$uct tet on pac;a"in" *ate!ial ue$ 'o! 'oo$, $!u", co*etic, *e$ical $e+ice
an$ ot#e! !elate$ p!o$uct.
0!o$uce p!ope!l&8b!e$ labo!ato!& ani*al ue$ 'o! to9icolo"ical e9a*ination, bioaa&
an$ biolo"ical !eea!c# an$ $e+elop*ent.
A$*init!ati+e Di+iion
Speci'ic Function
0!o+i$e "ene!al a$*init!ati+e an$ lo"itic uppo!t e!+ice uc# a pe!onnel,
'inance, co**unication, $ocu*entation, ecu!it&, an$ 'acilit& ope!ation an$ *aintenance
e!+ice.
7e"al Di+iion
Speci'ic Function
0!o+i$e le"al a$+ice in t#e en'o!ce*ent o' 'oo$ an$ $!u" la/ an$ !e"ulation.
2on$uct a$*init!ati+e p!ocee$in" an$ )uai8<u$icial #ea!in" on cae !elate$ to 'oo$
an$ $!u" la/ an$ !e"ulation.
0!epa!e !eco**en$ation, !eolution an$ ot#e! a$*init!ati+e iuance pe!tainin" to
!e"ulation o' p!ocee$ 'oo$, $!u", an$ ot#e! !elate$ p!o$uct.
2on$uct in+eti"ation o' conu*e! co*plaint on p!o$uct !e"ulate$ b& t#e (u!eau.
Monito! p!o$uct a$+e!tie*ent an$ p!o*otion to c#ec; co*pliance /it# e9itin"
"ui$eline on *e$ical an$ nut!itional clai*.