dietary supplements seminar 2004

8/20/2019 Dietary Supplements Seminar 2004

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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


3/27

&'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


4/27

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*


5/27

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


6/27

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


7/27

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+;


9/27

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


11/27

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


12/27

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


13/27

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


14/27

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# $-e!t$


15/27

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


16/27

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


17/27

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


18/27

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


19/27

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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21/27


22/27

E"#ST$T#ON

OCESS

Un%ue reg%$trt%on no

MAL*333


23/27

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


24/27

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


25/27

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+$


26/27

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


27/27

'tt-9 // 00061-f@6go56+#

dietary supplements seminar 2004

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