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DIRECTORATE OF RATIONAL DRUG USEDG OF PHARMACEUTICAL SERVICE & MEDICAL DEVICES
MINISTRY OF HEALTH, INDONESIA
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NATIONAL POLICYNATIONAL POLICY
TRADITIONAL MEDICINES IS TRADITIONAL MEDICINES IS AN INTEGRAL PART OF HEALTH CARE AN INTEGRAL PART OF HEALTH CARE
ENSURING ITS SAFETY, EFFICACY & QUALITYENSURING ITS SAFETY, EFFICACY & QUALITY
SUPPORT FURTHER DEVELOPMENT AND IMPROVEMENT OF FORMS OF SUPPORT FURTHER DEVELOPMENT AND IMPROVEMENT OF FORMS OF TRADITIONAL MED. TRADITIONAL MED.
DEEMED SAFE & EFFICACIOUS DEEMED SAFE & EFFICACIOUS IN ORDER TO FULFIL THE GOAL OF IN ORDER TO FULFIL THE GOAL OF
OPTIMAL HEALTH FOR THE COMMUNITYOPTIMAL HEALTH FOR THE COMMUNITY
MoH DECREE No: 47/MENKES/SK/II/1983MoH DECREE No: 47/MENKES/SK/II/1983
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POLICY
PROTECT THE COMMUNITY FROM DISADVANTAGE AND HAZARDS OF SUBSTANDARD PRODUCTS
CLINICAL PROVEN TRADITIONAL MEDICINES NEED TO BE DEVELOPED AND TO BE UTILIZED IN MEDICAL CARE FOR COMMNUNITY
MoH DECREE No: 47/MENKES/SK/II/1983MoH DECREE No: 47/MENKES/SK/II/1983
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WHO
ENCOURAGES AND SUPPORTSTHE INTEGRATION OF TRADITIONAL AND COMPLEMENTARYMEDICINE INTO NATIONAL HEALTH CARE SYSTEMAND TO ENSURETHEIR RATIONAL USE
(LEGAL STATUS OF TCM, WHO 2001)
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TRADITIONAL MEDICINES should comply
SAFE
EFECTIVE
QUALITY
RATIONAL USE
(WHO) (WHO) LEGAL STATUS OF TRADITIONAL MEDICINE LEGAL STATUS OF TRADITIONAL MEDICINE
AND COMPLEMENTARY/ ALTERNATIVE MEDICINE, 2002AND COMPLEMENTARY/ ALTERNATIVE MEDICINE, 2002
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CLASSIFICATION
JAMU (HERBAL MEDICINES)
EKSTRAK TERSTANDAR (STANDARIZED EXTRACT)
FITOFARMAKA (PHYTOPHARMACY)
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TOXYCITY TEST ACUTE (LD50)
SUBACUTE
CHRONIC
MUTAGENICITY
TERATOGENICITY
EMBRIOTOXICITY
CARSINOGENICITY
CLINICAL TEST (RCT) (MoH Decree No: 56 / 2000)
TM
SAFEEFECTIVEQUALITY
SAFEEFECTIVEQUALITY
GMP-TM
(Good Manufacturing Practice – Traditional Medicines) MoH Decree No: 659 / 1991
(KEPMENKES No: 650 Th 1991)
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STEPS FOR DEVELOPMENTSTEP I:STEP I:
PRE-CLINICAL TESTPRE-CLINICAL TEST
TOXYICITY TESTTOXYICITY TEST PHARMACODYNAMICAL TESTPHARMACODYNAMICAL TEST
SAFETYSAFETY EFFICACYEFFICACY
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SAFETY
TOXYCITYTOXYCITY:
GENERALGENERALTOXYCITYTOXYCITY
SPECIFICSPECIFICTOXYCITY TOXYCITY
ACUTE (LD50)ACUTE (LD50)SUB-ACUTESUB-ACUTE
CHRONICCHRONIC
TERATOGENICTERATOGENICMUTAGENICMUTAGENIC
CARCINOGENICCARCINOGENIC
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STEP II
INITIAL STANDARDIZATIONINITIAL STANDARDIZATION
STEP IIISTEP III
PHARMACEUTICAL TECHNOLOGY PHARMACEUTICAL TECHNOLOGY WHICH DEFINE IDENTITY ACURATELYWHICH DEFINE IDENTITY ACURATELY
TO STANDARIZED PRODUCTTO STANDARIZED PRODUCT
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STEP IV
EFFICACY: EFFICACY:
CLINICAL TEST CLINICAL TEST
ACCORDING TO ACCORDING TO GCPGCP
(GOOD CLINICAL PRACTICES)(GOOD CLINICAL PRACTICES)
RANDOMIZEDRANDOMIZED
DOUBLE BLIND CONTROLDOUBLE BLIND CONTROL
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CLINICAL TEST
RESULTSRESULTS
AS A CONDITION FOR REGISTRATION AS A CONDITION FOR REGISTRATION
FURTHER UTILIZATION IN FORMAL HEALTH FURTHER UTILIZATION IN FORMAL HEALTH CARE EFFORTSCARE EFFORTS
KEPMENKES No: 56/MENKES/SK/I/2000
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PHYTOPHARMACY
TRADITIONAL MEDICINES
WHICH HAVE BEEN PROVEN
SAFE, EFECTIVE
QUALITY
STANDARDIZED
MoH Decree No: 760 / 1992
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PHYTOPHARMACY
EQUAL TO MODERN MEDICINES
ABLE TO PRESCRIBED BY PHYCISIANS
ABLE TO UTILIZED
IN A FORMAL HEALTH CARE FACILITIES
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PHYTOPHARMACY
TENSIGARD
PHYTODIAR
RHEUMANEER
X GRA
STIMUNO
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SP3TCENTRE OF
DEVELOPMENT & APPLICATION TRADITIONAL MEDICINES
PERFORM CLINICAL TESTING POTENTIAL ADVANCED TO
PHYTOPHARMACY
(MoH Decree No. 0584/MENKES/SK/VI/1995)
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TRADITIONAL MEDICINES
PROHIBITED
MIXED/COMPOUNDED
WITH MODERN MEDICINES
MoH Decree 246/Menkes/Per/V/1990MoH Decree 246/Menkes/Per/V/1990
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MoH Decree No 1147/D/SK/IV/81 23 JUNE 1977
PROHIBIT PROCUCTION & DISTRIBUTION SUPOSITORIA, INTRAVAGINAL & EYE DROPS OF TM
GUIDELINE OF TRADITIONAL MEDICINES
1985 LABELLING TM
1993 REGULATION TM
MoH Decree No 1516/A/81, 15 MAY 1981TM CONTAIN ETANOL
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MEDICATION WITH TM
SHORT TERM
SAFETY PROVEN
LONG TERM
SAFETY & EFICACY PROVEN
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DEVELOPMENT STRATEGY
DATA COLLECTION
DEVELOP MEDICATION GUIDELINES
DEVELOP PILOT PROJECT
MONITORING & EVALUATION
DEVELOP TO PHYTOPHARMACY
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NOT YET PROVEN IN SAFETY AND EFICACY
ABLE TO UTILIZED OUTSIDE FORMAL MEDICAL CARE
BY MEDICAL STAFF
FOR RESEARCH PURPOSE
COMPLY WITH GOOD CLINICAL PRACTICE (GCP)
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TM
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TM