POLICY OF TRADITIONAL MEDICINES
اسلاید 1: www.tabaye.ir
اسلاید 2: DIRECTORATE OF RATIONAL DRUG USEDG OF PHARMACEUTICAL SERVICE & MEDICAL DEVICESMINISTRY OF HEALTH, INDONESIAPOLICY OFTRADITIONAL MEDICINES
اسلاید 3: 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 COMMUNITYMoH DECREE No: 47/MENKES/SK/II/1983
اسلاید 4: POLICY PROTECT THE COMMUNITY FROM DISADVANTAGE AND HAZARDS OF SUBSTANDARD PRODUCTSCLINICAL PROVEN TRADITIONAL MEDICINES NEED TO BE DEVELOPED AND TO BE UTILIZED IN MEDICAL CARE FOR COMMNUNITYMoH DECREE No: 47/MENKES/SK/II/1983
اسلاید 5: WHOENCOURAGES AND SUPPORTSTHE INTEGRATION OF TRADITIONAL AND COMPLEMENTARYMEDICINE INTO NATIONAL HEALTH CARE SYSTEMAND TO ENSURETHEIR RATIONAL USE(LEGAL STATUS OF TCM, WHO 2001)
اسلاید 6: TRADITIONAL MEDICINES should complySAFEEFECTIVEQUALITYRATIONAL USE(WHO) LEGAL STATUS OF TRADITIONAL MEDICINE AND COMPLEMENTARY/ ALTERNATIVE MEDICINE, 2002
اسلاید 7: CLASSIFICATIONJAMU (HERBAL MEDICINES)EKSTRAK TERSTANDAR (STANDARIZED EXTRACT)FITOFARMAKA (PHYTOPHARMACY)
اسلاید 8: TOXYCITY TEST ACUTE (LD50) SUBACUTECHRONICMUTAGENICITY TERATOGENICITYEMBRIOTOXICITYCARSINOGENICITYCLINICAL TEST (RCT) (MoH Decree No: 56 / 2000) TMSAFEEFECTIVEQUALITY GMP-TM(Good Manufacturing Practice – Traditional Medicines) MoH Decree No: 659 / 1991(KEPMENKES No: 650 Th 1991)
اسلاید 9: STEPS FOR DEVELOPMENTSTEP I:PRE-CLINICAL TESTTOXYICITY TESTPHARMACODYNAMICAL TESTSAFETYEFFICACY
اسلاید 10: SAFETYTOXYCITY:GENERALTOXYCITY SPECIFICTOXYCITY ACUTE (LD50)SUB-ACUTECHRONICTERATOGENICMUTAGENICCARCINOGENIC
اسلاید 11: STEP IIINITIAL STANDARDIZATIONSTEP IIIPHARMACEUTICAL TECHNOLOGY WHICH DEFINE IDENTITY ACURATELY TO STANDARIZED PRODUCT
اسلاید 12: STEP IVEFFICACY: CLINICAL TEST ACCORDING TO GCP(GOOD CLINICAL PRACTICES)RANDOMIZED DOUBLE BLIND CONTROL
اسلاید 13: CLINICAL TESTRESULTSAS A CONDITION FOR REGISTRATION FURTHER UTILIZATION IN FORMAL HEALTH CARE EFFORTSKEPMENKES No: 56/MENKES/SK/I/2000
اسلاید 14: PHYTOPHARMACYTRADITIONAL MEDICINES WHICH HAVE BEEN PROVEN SAFE, EFECTIVE QUALITY STANDARDIZEDMoH Decree No: 760 / 1992
اسلاید 15: PHYTOPHARMACYEQUAL TO MODERN MEDICINESABLE TO PRESCRIBED BY PHYCISIANSABLE TO UTILIZED IN A FORMAL HEALTH CARE FACILITIES
اسلاید 16: PHYTOPHARMACYTENSIGARDPHYTODIARRHEUMANEERX GRASTIMUNO
اسلاید 17: SP3TCENTRE OF DEVELOPMENT & APPLICATION TRADITIONAL MEDICINESPERFORM CLINICAL TESTING POTENTIAL ADVANCED TO PHYTOPHARMACY(MoH Decree No. 0584/MENKES/SK/VI/1995)
اسلاید 18: TRADITIONAL MEDICINESPROHIBITED MIXED/COMPOUNDED WITH MODERN MEDICINESMoH Decree 246/Menkes/Per/V/1990
اسلاید 19: MoH Decree No 1147/D/SK/IV/81 23 JUNE 1977 PROHIBIT PROCUCTION & DISTRIBUTION SUPOSITORIA, INTRAVAGINAL & EYE DROPS OF TMGUIDELINE OF TRADITIONAL MEDICINES 1985 LABELLING TM1993 REGULATION TMMoH Decree No 1516/A/81, 15 MAY 1981TM CONTAIN ETANOL
اسلاید 20: MEDICATION WITH TMSHORT TERMSAFETY PROVENLONG TERMSAFETY & EFICACY PROVEN
اسلاید 21: DEVELOPMENT STRATEGY DATA COLLECTIONDEVELOP MEDICATION GUIDELINESDEVELOP PILOT PROJECTMONITORING & EVALUATIONDEVELOP TO PHYTOPHARMACY
اسلاید 22: NOT YET PROVEN IN SAFETY AND EFICACYABLE TO UTILIZED OUTSIDE FORMAL MEDICAL CAREBY MEDICAL STAFFFOR RESEARCH PURPOSE COMPLY WITH GOOD CLINICAL PRACTICE (GCP)
اسلاید 23: TM
اسلاید 24: TERIMA KASIHTMTHANK YOU
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