Transcript PENERTIBAN PENEBANGAN LIAR HUTAN PRODUKSI

DIRECTORATE OF RATIONAL DRUG USE
DG OF PHARMACEUTICAL SERVICE & MEDICAL DEVICES
MINISTRY OF HEALTH, INDONESIA
NATIONAL POLICY
TRADITIONAL MEDICINES IS
AN INTEGRAL PART OF HEALTH CARE
ENSURING ITS SAFETY, EFFICACY & QUALITY
SUPPORT FURTHER DEVELOPMENT AND IMPROVEMENT
OF FORMS OF TRADITIONAL MED.
DEEMED SAFE & EFFICACIOUS
IN ORDER TO FULFIL THE GOAL OF
OPTIMAL HEALTH FOR THE COMMUNITY
MoH DECREE No: 47/MENKES/SK/II/1983
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/1983
WHO
ENCOURAGES AND SUPPORTS
THE INTEGRATION OF
TRADITIONAL AND COMPLEMENTARY
MEDICINE
INTO
NATIONAL HEALTH CARE SYSTEM
AND TO ENSURE
THEIR RATIONAL USE
(LEGAL STATUS OF TCM, WHO 2001)
TRADITIONAL MEDICINES
should comply
SAFE
EFECTIVE
QUALITY
RATIONAL USE
(WHO) LEGAL STATUS OF TRADITIONAL MEDICINE
AND COMPLEMENTARY/ ALTERNATIVE MEDICINE, 2002
CLASSIFICATION
JAMU (HERBAL MEDICINES)
EKSTRAK TERSTANDAR
(STANDARIZED EXTRACT)
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
FITOFARMAKA (PHYTOPHARMACY)
TM
TOXYCITY TEST
(KEPMENKES No: 650 Th 1991)
ACUTE (LD50)
SUBACUTE
CHRONIC
MUTAGENICITY
TERATOGENICITY
EMBRIOTOXICITY
CARSINOGENICITY
CLINICAL TEST (RCT)
(MoH Decree No: 56 / 2000)
GMP-TM
(Good Manufacturing Practice – Traditional Medicines)
MoH Decree No: 659 / 1991
SAFE
EFECTIVE
QUALITY
STEPS FOR DEVELOPMENT
STEP I:
PRE-CLINICAL TEST
TOXYICITY TEST
SAFETY
PHARMACODYNAMICAL TEST
EFFICACY
SAFETY
TOXYCITY:
GENERAL
TOXYCITY
ACUTE (LD50)
SUB-ACUTE
CHRONIC
SPECIFIC
TOXYCITY
TERATOGENIC
MUTAGENIC
CARCINOGENIC
STEP II
INITIAL STANDARDIZATION
STEP III
PHARMACEUTICAL TECHNOLOGY
WHICH DEFINE IDENTITY ACURATELY
TO STANDARIZED PRODUCT
STEP IV
EFFICACY:
CLINICAL TEST
ACCORDING TO GCP
(GOOD CLINICAL PRACTICES)
RANDOMIZED
DOUBLE BLIND CONTROL
CLINICAL TEST
RESULTS
AS A CONDITION FOR REGISTRATION
FURTHER UTILIZATION IN FORMAL HEALTH
CARE EFFORTS
KEPMENKES No: 56/MENKES/SK/I/2000
PHYTOPHARMACY
TRADITIONAL MEDICINES
WHICH HAVE BEEN PROVEN
SAFE, EFECTIVE
QUALITY
STANDARDIZED
MoH Decree No: 760 / 1992
PHYTOPHARMACY
EQUAL TO MODERN MEDICINES
ABLE TO PRESCRIBED BY PHYCISIANS
ABLE TO UTILIZED
IN A FORMAL HEALTH CARE FACILITIES
PHYTOPHARMACY
TENSIGARD
PHYTODIAR
RHEUMANEER
X GRA
STIMUNO
SP3T
CENTRE OF
DEVELOPMENT & APPLICATION
TRADITIONAL MEDICINES
PERFORM CLINICAL TESTING
POTENTIAL ADVANCED TO
PHYTOPHARMACY
(MoH Decree No. 0584/MENKES/SK/VI/1995)
TRADITIONAL MEDICINES
MoH Decree 246/Menkes/Per/V/1990
PROHIBITED
MIXED/COMPOUNDED
WITH MODERN MEDICINES
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 1981
TM CONTAIN ETANOL
MEDICATION WITH TM
SHORT TERM
SAFETY PROVEN
LONG TERM
SAFETY & EFICACY PROVEN
DEVELOPMENT STRATEGY
DATA COLLECTION
DEVELOP MEDICATION GUIDELINES
DEVELOP PILOT PROJECT
MONITORING & EVALUATION
DEVELOP TO PHYTOPHARMACY
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)

TM

TM