Oktober 2005. Volume 3, No. 3

Drug and Food Gontrol
BADAN
Newsletter
RI
N"ttqril Ag"r"y
"f
Volume 3 No.3, October 2005
The 3o edition ofNADFC Newsletter published in medio
October 2005 is strive to give the readers on some
imporTant news, public warnings and regular activities
of NADFC in the third quafter of 2005. One of the
ls that the
important neyvs
NADFC has been
successfu//y aciomplished the WHO assessmenf of
National Vaccine Regulatory System on 15-19 August
2005. The investigation team of NADFC suppofted by
N QCLD F fo u nd trad iti o n al med ici ne s wh ich we re mi xed
with chemical subsfances. In order to protect the
people's health, the NADFC then published public
warnings which were also disseminated to all regional
offices of NADFC throughout Indonesia.
UNITAR supporfs a limited number of country-based
projects which meant to strengthen capacities and
facilitate development of a national GHS
implementation strategy. These projects are executed
by
UNITAR with funding from the government of
Switze rl a ndand Eu rope a n Com m i ssi on.
Hearing with House of Parliament members, dlscussed
about the importance of having regulations on food and
drug control. The
9''
ASEAN Food Conference 2005
was held on 8-10 August 2005 in Bidakara Hotel,
Jakarla. The Conference discussed currentissues on
Ethnic and traditional Food, Food Technology
Education, Food Processing Engineering, Food Safety,
and Nutrition and Health. The Conference was
officially opened by the Minister
of Research
and
Technology.
Regulation Government of Republic of lndonesia no. 21
2005 regarding Genetically Modified Product was
signed by President Republic of lndonesia on 19 May
2005 in Jakarta.
Thankyou.
/
Public Worning : ARMA S/N GAIVG SAN
LANGS/NG AYU Product Confoining Drug
C hem ico I Subs/onces Sl BUTRAM I N E
HYDROCHLORTDE
UNITAR
...
..........
1
Copocity Building Progrctmme in
/ndoneslo
............
The WHO Assessrnenl of The Notronctl
Voccine ReguloforySyslem in lndonesio
Public Worning : lllegol Producf Confctining
Drug Chemicol Substonce SILDENAFIL
CITRATE
2
.....
2
......
2
Governmenl Regulotion No.21 yeor 2005
on Biosofely of Geneficolly Modified
Product
......
4
Ihe 9'' ASFAN Food Conference 2005 . . .. . .. 4
NADFC's Vision ond Mlsslon lmplementotion
on Achieve Sofely ond quolily s/ondords
Phormoceulicol
I
Producls
olrtrtta -l Nr.r.-1. Octohcr' )005
.... ....
..
..
4
l-l
ffi
V
supports a limited number of country based projects
to strengihen capacities and facilitate development of
a national GHS implementation strategy, in the context of the
UNITAR Globally Harmonized System of Classification and
Agency for each of the four sectors of transport, industrial
production, agriculture and consumer products as well as
the industry and civil society partners. The lead sectoral
agency for transport is Ministry of Transportation, lndustrial
production is Ministry of lndustry, Agricultural is Ministry of
Labelling-
Agriculture, Consumer Product is Ministry of Trade.
eginning in 1 June 2005 until 31 May 2007-, UNITAR
of
Programm'e,
Chemicals (GHS) Capacity Building
with funding from the Government of
Switzerland and the European Commission.
The overallgoal of the national GHS projects is to strengthen
capacities to implement the GHS by the year 2008. lt thus
contributes both to the protection of human health and the
environment from dangerous chemicals, and to facilitating
the trade in chemicals between countries and their trading
partners. Illore specifically, national projects aim at
achieving the following objectives for the four sectors
affected by the GHS. A National GHS lmplementation
Committee (or an existing committee) comprising representatives of ministries and stakeholder groups for the
purpose of advising matters of project implementation and
drafting laws/regulations will be established in each partner
country. NADFC is designated as a Project Coordinating
For the duration of the project, NADFC as the Coordinating
Agency will convene meetings of the GHS lmplementation
Committee; provide secretariat support to the project; and
coordinate participation of national representatives at GHSrelevant international meetings.
The project is divided into three phases as follows :
1. Phase 1 : Preparation of a GHS situation/Gap analysis
and Comprehensibility Testing (approximately 6
2.
3.
months)
2 : Targeted GHS Capacity Development
(approximately I 2 months)
Phase 3 : Development of a Sirategic plan (Road map)
Phase
for National GHS lmplementation by
2008
(approximately 6 months).-
The programms of the visit are as follows:
r/
ln medio of August 2005, the National Agency of Drug and
Food Control (NADFC) as a National Regulatory Authority
(NRA) has been visited by the WHO review team in the
context
of the programme on assessment of
national
vaccine regulatory system in lndonesia. Mr. R. Dobbelaer
from NCL Belgium as a team leader.
The previous assessment were conducted in 200'l for
pharmaceutical and biologycal product and 2003 for
biologycal product. The objectives of these programms are
to assess the national vaccine regulatory system against
the WHO published indicators and to develop and submit an
updated institutional development plan.
The main objective was to review the regulation and control
of vaccines conducted by NADFC and review relevant
functions or areas that may involve other institutions such as
the National lmmunization Programme (NEPI) against the
WHO published NRA indicators. This activity included
identifying specific technical inputs that may be needed by
the national vaccine regulatory system to meet the NRA
critical indicators required by the WHO prequalification.
Iitltrnta.l No..l.
Ot rohu' 1005
r/
r/
r/
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Review of the functions during the 2003 review and
achievements reported (NADFC and NEPI) at central
and district level NADFC and NEPI
Regulatory inspections in a Regional NADFC Office
Review of Regulatory inspections, Clinical evaluation of
safety and efficacy and Post-marketing surveillance
Visit to vaccine manufacturer to document GMP
enforcement
Visit to immunization and disease surveillance
programme
Presentation of the findings and discussions of the
recommendations technical inputs needed, timelines,
funding sources, and mechanisms
for
monitoring
progress and impact and identify training needs for
each relevant functions and indicators.-
The other objective is to find and formulate list of gaps on
technical inputs needed, timelines, funding sources, and
mechanisms
for monitoring progress and impact and
training needs for each relevant functions and indicators.
Most of the indicators assessment on NADFC have been
improved compared to 2003 result.-
!q.
\
trl
g
,l
Jamu Sehat Pria "Seki", Samiaji,
Capsul/TR.003202221 (fictiv e number)
Jamu "Pasihot" Andalan Pria Perkasa,
capsul/TR.003202301 (fi ctive number)
Tablet "Cobra Laut" TR.003200621 (fictive number)
10
11
12
13
14
15
Tablet "Pas-Tipas", Obat Kuai dan Tahan Lama/
without registraiion number
Obat Kuat dan Tahan Lama "Busur Perkasa",
Capsul/TR.89351 8901 (fictive number)
Obat Kuat dan Tahan Lama "X-mas" (siated as Klimax),
Capsul/TR.048277 503 (fi ctive number)
Obat Kuat dan Tahan Lama "Pegasus Kuda Terbang",
Capsul/TR.024341 57 2 (fictive number)
Obat Kuat "Spider",
Capsul/TR.99357 58412 (fictive number)
Obat penambah Vitalitas Pria "Scorpion",
capsul/TR.022341563 (fictive number)
Penambah vitalitas dan Gairah Sex "Vi-Gra",
capsul/TR.022341 563 (fictive number)
Obat Kuat Pria Dewasa "Pastigra,
capsul/TR.04258336 1 (fictive number)
Jamu Kuat dan Tahan Lama "Kuda Mas",
capsul/TR.0243511 47 2 (fictive number)
Jamu Kuat Perkasa "Spontan On,
capsuliTR.023 4357 32 (fictive number)
Obat Kuai Andalan Pria Dewasa "Bali-Bali",
capsul/TR.023541 832 (fictive number)
Obat Kuat Andalan Pria Merk "Bali-Bali",
capsul/TR.2336457'108 (fictive number)
Iitlttntt,-l
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tohcr' )00
j
Kopja Aneka Sari,
Jawa Tengah, lndonesia
PJ. Khasiat Makasar
lndonesia
PJ. Tawon Api Makasar
Banyumas
Drs. Naspan, Cilacap
Sildenafil Citrate
Not registered / illegal
Sildenafil Citrate
Not registered / illegal
Sildenafil Citrate
Not registered / illegal
Sildenafil Citrate
Not registered / illegal
PJ. Bangun Sukses
Perkasa, Denpasar
PJ. Great Herb,
lndonesia
PJ. Alam Sehat, Jabar
Sildenafil Citrate
Not registered / illegal
Sildenafil Citrate
Not registered / illegal
Sildenafil Citrate
Not registered / illegal
PJ. Sinar Makmur,
Madura
PJ. Sinar Makmur,
Madura
Hema Care
Sildenafil Citrate
Not registered / illegal
Sildenafil Citrate
Not registered / illegal
Sildenafil Citrate
Not registered / illegal
Hema Care
Sildenafil Citrate
Not registered
PJ. MakmurAbadi,
Jatim
PJ. Sinar Wahyu,
Sumbar
PJ. Madura Sakti
Sildenafil Citrate
Not registered / illegal
Sildenafil Citrate
Not registered / illegal
Sildenafil Citrate
Not registered / illegal
PT. Jaya Makmur,
Sildenafil Citrate
Not registered / illegal
Bandung
t
i
illegal
Drug and Food Gontrol Newsletter
Advisors:Drs. H. Sampurno, MBA; Mawanvati Djamaluddin, Dipl. Pharm; Chief Editor:E.D. Syarief Syamsuri, MSc;
Secretary Editor : Dra. Yunida Nugrahanti; Editorial Staff : Drs. Rahardjo, Dra. Tutut Sumartini, Dra. Lia Marliana,
MKes, Dra. Diah Tritunggariani, MKes, Yanni Parmawati, SSi; Distribution : Jaeni, Delima
Address : Bureau of lnternational Cooperation, The National Agency of Drug and Food Control Republic of lndonesia,
Jalan Percetakan Negara No. 23 Jakarta 10560 lndonesia email : [email protected], website :www.pom.go.id
Volume 3 No.3, October
2005
4