dietary supplements seminar 2004
TRANSCRIPT
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CONTROL OF DIETARY
SUPPLEMENTS INMALAYSIA
TAN LIE SIE
DRUG EVALUATION AND SAFETY DIVISIONNATIONAL PHARMACEUTICAL CONTROL BUREAU
MINISTRY OF HEALTH MALAYSIA
Seminar on dietary supplements - 15 January 2004
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CONTENTS
Food / Drug Interf!e
Regu"tor# Pro!e$$ %n M"#$%
Con!ern$
Con!"u$%on
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&'t %$ t'%$ %nterf!e(
) %nter!t%on of *
regu"tor# reg%+e$, ) no %nternt%on""#
$tndrd%$ed --ro!',
) !o+-"e. 0%t' -u1"%!'e"t' nd $fet#%+-"%!t%on$
FOOD/D!" #NTEF$CE
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Guide to Classification of Food-Drug Interface Products(Guide to determining if a product is to be regulated by the NPCB/FQC)
Product
Ingredients
Pure Form of activeingredient (singly or in
combination)
Natural product that are nottraditionally used as food and of
medicinal value
Food base
♦Vitamin♦mineral♦amino acid
♦Fatty acid
♦Fibre♦LyophilizedBacteria♦nzyme
• !lfalfa tablets•"pirulina•#oyal $elly•Noni $uice
•Pegaga tablet•%erbal product
&' or more
Food base
Less than &' food base or more
than ' active ingredients of
natural products* But if the latterpossess high potencies+ the product
shall be revie,ed by the -ommittee+
even if they contain less than ' of
these ingredients*NPCB-National Pharmaceutical Control Bureau
FQC – Food Quality Control Division
. If a product is more than &' food based but contains pure forms of active ingredient (e*g*/ vitamins 0 minerals) that e1ceed the amounts permitted in Food #egulations 23&4
the company shall be advised to reduce the amounts of these active ingredients and be regulated by F5-*
. Intended use and claim should not be used as sole criteria for classification but can be used as a guide
. Instruction for use and pharmaceutical dosage form li6e tablet+ capsule+ should not be used as criteria for classification but can be used as a guide*
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If -rodu!t !ont%n$ "e$$ t'n 234 offood)1$ed %ngred%ent$ nd +ore t'n*34 of t'e !t%5e %ngred%ent$ $u!'
-rodu!t $'"" 1e regu"ted 1# NPCB6Not 0%t'$tnd%ng t'%$ gener" ru"e for$-e!%7! %ngred%ent$ 0'%!' -o$$e$$'%g' -oten!%e$ e5en %f t'e# !ont%n"e$$ t'n *34 of t'e !t%5e
%ngred%ent$ t'e# $'"" 1e re5%e0ed 1#t'e !o++%ttee nd +# 1e regu"ted1# NPCB %f %t %$ found ne!e$$r#
FOOD/D!" #NTEF$CE
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If -rodu!t %$ +ore t'n 234 food 1$ed 1ut
!ont%n$ -ure for+$ of !t%5e
%ngred%ent 8e6g69 5%t+%n$ : +%ner"$;t't e.!eed t'e +ount$ -er+%tted %nFood Regu"t%on$
t'e !o+-n# $'"" 1e d5%$ed to
redu!e t'e+ount$ of t'e$e !t%5e %ngred%ent$nd 1e
regu"ted 1# B?MM6
FOOD/D!" #NTEF$CE
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Fo""o0%ng !r%ter% $'ou"d not 1e u$ed $$o"e !r%ter% for !"$$%7!t%on 1ut !n 1eu$ed $ gu%de
Intended u$e nd !"%+
In$tru!t%on for u$e nd -'r+!eut%!"do$ge for+$ "%@e t1"et !-$u"e et!
FOOD/D!" #NTEF$CE
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DRUG CONTROL AUTHORITY
NATIONAL PHARMACEUTICAL
CONTROL BUREAU 8NPCB;8$ Se!retr%t / E.e!ut%5e Ar+;
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D!" CONTO% $!T&O#T'
(DC$) Reg%$ter "" drug$ 8-re$!r%-t%on
o5er)t'e)!ounter nd 'er1"
+ed%!%ne$; nd !o$+et%! -rodu!t$ L%!en$e +nuf!turer$ %+-orter$
nd 0'o"e$"er$ of reg%$tered
-rodu!t$ Mon%tor t'e u"%t# nd $fet# of
+r@eted -rodu!t$ t'roug' Po$t)Reg%$trt%on Mr@et Sur5e%""n!e :
Ad5er$e Drug Re!t%on$ Re-ort%ng
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T*e Control o+ Dru,s and
Cosmetis e,ulations1.4
Regu"t%on 8
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T*e Control o+ Dru,s and
Cosmetis e,ulations1.4
A -rodu!t$ de7ned %n t'eRegu"t%on$ +en$ a dru, in a p*armaeutial dosa,e +orm or aosmeti *ain, a sin,ular
identity omposition *arateristisand ori,in3
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T*e Control o+ Dru,s
and Cosmetise,ulations 1.4A drug %$ u$ed on 'u+n$ 8nd n%+"$;
to -re5ent !ure tret or redu!e
%""ne$$ to d%gno$e d%$e$e
for !ontr!e-t%on
to %ndu!e ne$t'e$% 8$edte;
to !'nge or to !ontro" -'#$%o"og%!"fun!t%on
to !ontro" 1od# 0e%g't
gener" +%ntenn!e or -ro+ot%on of
'e"t' or 0e"" 1e%ng
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D#ET$'
S!%EENTS Produ!t$ %ntended to $u--"e+ent t'e
d%et t@en 1# +out' %n for+$ $u!' $-%""$ !-$u"e$ t1"et$ "%u%d$ or-o0der$ nd not re-re$ented $!on5ent%on" food6
M# %n!"ude %ngred%ent$ $u!' $
V%t+%n$ M%ner"$ A+%no A!%d$Ntur" Su1$tn!e$ of -"nt/n%+" or%g%nEn#+e$
Su1$tn!e$ 0%t' nutr%t%on" / -'#$%o"og%!"
fun!t%on
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6*y re,ister dietary
supplements7Need to -rote!t !on$u+er
%ntere$t$
Re!ord of -rodu!t$ reg%$terednd t'e%r re$-e!t%5ere$-on$%1"e +r@et ut'or%t%on'o"der$ nd +nuf!turer$
Mon%tor%ng nd enfor!e+ent Regu"te !"%+$
Sfet# $-e!t$
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E"#ST$T#ON C#TE#$
SAFETY Produ!t$ 0%"" not 1e reg%$tered %f t'ere
re -u1"%! 'e"t' !on!ern$ 1$ed on
$fet# !on$%dert%on$ 8%ngred%ent$u$ed !o+1%nt%on$;
U--er d%"# "%+%t$ $et for $o+e5%t+%n$ nd +%ner"$
&rn%ng$/-re!ut%on$ +# 1e reu%red%n -rodu!t "1e""%ng
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E"#ST$T#ON C#TE#$
UALITY H5e to !o+-"# 0%t' !urrent Good
Mnuf!tur%ng Pr!t%!e$ 8!GMP;
reu%re+ent$
) %nfr$tru!ture /f!%"%t%e$
) -er$onne"
) -ro!e$$e$ nd !ontro"$
S'ou"d !onfor+ to $et $tndrd$ of u"%t#
) r0 +ter%"$
) 7n%$'ed -rodu!t
) $t1%"%t# te$t%ng
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E"#ST$T#ON C#TE#$
CLAIMS 8 EFFICACY ;
Su--"e+ent$ +# not 1er d%$e$e !"%+$
8%e !-1"e of !ur%ng tret%ng or-re5ent%ng d%$e$e;, e%t'er e.-"%!%t or%+-"%ed
A""o0ed to 1e %nd%!ted $ D%etr# /Food/ Nutr%t%on" Su--"e+ent
Fun!t%on !"%+$ 0'%!' de$!r%1e t'e-'#$%o"og%!" ro"e of t'e nutr%ent %nnor+" fun!t%on%ng of t'e 1od# +# 1e-er+%tted
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E"#ST$T#ON
OCESSOn)"%ne reg%$trt%on -ro!e$$8$%ng"e $tge;
Implementation of the on-lineregistration system :
1 July 20031 July 2003 - for pharmaceuticals(generics), and the “!"# products
1 January 200$1 January 200$ - for traditionalproducts
1 %ac 200$1 %ac 200$ - targeted date for the
&"' and iotech products
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Flo Chart of !egistration Process
"Pre-mar#et $%%roval&
egal *e+uirements
uidelines, "riteria,
rocess (a.ridged) /uality test for
traditional products
Obtain smart card
JKPP
Applicant
BPFK evaluate
application
Request for
additional info
Prepare evaluationreport
Request for
additional
info
Secretariat
Not
satisfactorySatisfactory
Report
complete
Report
incomplete
DA
Input data 0 submit
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E"#ST$T#ON
OCESS
Un%ue reg%$trt%on no
MAL*333
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CONCENS
Con$u+er -er!e-t%on t't -rodu!t %nt'e for+ of mediine %$ -er!e%5ed to1e drug for tret+ent
Re$-on$%1"e %nfor+t%on -ro5%$%on6 T'ere%$ -otent%" '%g' r%$@ to !on$u+er$ $ re$u"t of %n$u!%ent or %n!orre!t%nfor+t%on or frudu"ent -rodu!t$6
) A"t'oug' -rodu!t +# not 1e to.%! or
dngerou$ !on$u+er$ +# !o+-ro+%$et'e%r 'e"t' 1# not $ee@%ng -ro-er+ed%!" ttent%on6
) C"%+$ 1out $u--"e+ent$ $'ou"d notd%5ert ttent%on 0# fro+ et%ng 'e"t'# d%et
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CONC%!S#ON
T'ere %$ tre+endou$ %ntere$t %n
nd de+nd for 'e"t'$u--"e+ent$ nd need forregu"tor$ to !!o++odte
1ot' t'e %ndu$tr# nd!on$u+er$ %n t'%$ re6
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CONC%!S#ON
Ho0e5er t'e gro0%ng +r@et
for $u--"e+ent$ %n "e$$re$tr%!t%5e regu"tor#
en5%ron+ent !rete$ t'e-otent%" for $u--"e+ent$ to 1e
-rone to u"%t#)!ontro"-ro1"e+$
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CONC%!S#ON
Aut'or%t# to regu"te nd
--ro5e -rodu!t reg%$trt%onnd "%!en$%ng t'roug' -re)+r@et $$e$$+ent 'e"-$
en$ure t't !on$u+er$ '5e!!e$$ to $fe '%g' u"%t#-ro-er"# "1e"ed -rodu!t$6
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