ruslan aspan deputy of traditional drug, cosmetics and complementary product control
DESCRIPTION
EVALUATION OF. PHYTOPHARMACA. Product IN. Indonesia. Ruslan Aspan Deputy of Traditional Drug, Cosmetics and Complementary Product Control NATIONAL AGENCY OF DRUG AND FOOD CONTROL. EVALUATION OF. PHYTOPHARMACA. Product In. Indonesia. DEF : - PowerPoint PPT PresentationTRANSCRIPT
Ruslan Aspan
Deputy of Traditional Drug, Cosmetics and Complementary Product Control
NATIONAL AGENCY OF DRUG AND FOOD CONTROL
EVALUATION
OF
Product
IN
DEF :
Substances or mixture of substances forming from herbals, plants, animal parts and/or mineral raw materials, galenic preparation that has long historical used (It is the sum total of the knowledges, skills and practices based on the theories, beliefs and experiences indigenous to different cultures) empirically being used for the maintenance of health as well as in the treatment use.
Product In
EVALUATION OF
• Jamu have been recognized and used in Indonesia for many ages, as part of Indonesian culture
• It has been used for health purpose, including promotive, preventive, curative and rehabilitative purposes.
• At 18th century, as order of Sunan Pakubuwono (King of Surakarta Kingdom) was written a compilation of traditional medicines recipees (The book is known as “Serat Centini”)
Product In
EVALUATION OF
INDONESIAN TRADITIONAL MEDICINES (JAMU)
• “Minum Jamu” (Jamu Drinking) is Indonesian habit, done every morning before go to work, for maintain their health.
• At the beginning jamu was made from fresh plants at household, since the 20th century, jamu has been produced by industries, using modern technologies as well as hygiene sanitation aspect.
Product In
EVALUATION OF
INDONESIAN TRADITIONAL MEDICINES (JAMU)
According to the SUSENAS 2001 (National Economic Survey), 31.7% Indonesian citizens are practicing their health maintenance through traditional medicine utilization, wich made by:
– Home made 3.7 %– Jamu peddlers 14.5 %– Industries 13.5%
Product In
EVALUATION OF
Currently, there are 1.046 traditional medicines industries in Indonesia (big, small and micro scale industry).
47 pharmaceutical industries also produce traditional medicine
Product In
EVALUATION OF
Example of some big scale of traditional medicine industries:
– PT. Nyonya Meneer in Central Java.– PT. Sido Muncul in Central Java.– PT. Martina Berto in Jakarta.– PT. Mustika Ratu in Jakarta.– PT. Deltomed in Central Java– PT. Jamu Jago in Central Java.– PT. Air Mancur in Central Java.– PT. Simona in Central Java.– PT. Sari Sehat in Central Java.– PT. Sinde Budi Sentosa in Jakarta
Product In
EVALUATION OF
Some examples of pharmaceutical industries which produce traditional medicine:
– PT. Indo Farma– PT. Kimia Farma– PT. Phapros– PT. Soho – PT. Dexa Medica
Product In
EVALUATION OF
Product In
EVALUATION OF
JAMU
PHYTOPHARMACAFITOFARMAKA
SELF MEDICATION
-General Practitioner-Community Health Center-Hospital
EVIDENCE BASE
PRE-CLINICAL TRIAL &PRE-CLINICAL TRIAL &STANDARDIZATION STANDARDIZATION
OF PLANT MATERIALSOF PLANT MATERIALS
CLINICAL TRIALCLINICAL TRIAL
EMPIRICAL EVIDENCEEMPIRICAL EVIDENCETRADITIONAL medicinesTRADITIONAL medicines
STANDARDIZED HERBAL
MEDICINE
PHYTOPHARMACA
JAMUJAMU
Badan Pengawas Obat dan Makanan
Product In
EVALUATION OF
INDONESIAN HERBAL MEDICINE
TWO STEPS OF REGISTRATION AND EVALUATION :
1. Pre evaluation step :
To determine evaluation path, completeness and validity of registration documents, registration and evaluation fee.
2. Evaluation steps:
Submission of registration documents and evaluation process.
Application of
Registration documents
• Determination of registration path• Check completeness and validity of registration documents i.e.
administrative doc technical doc
PRE EVALUATIONPRE EVALUATIONRESULTRESULT
COMPLETE &CORRECT DOC
INCOMPLETE ORUNCORRECT DOC
ADITIONAL ORCORRECTION OF
DATARESPONS IN WRITINGTO PAY
THE REGISTRATION FEE
FLOW OF REGISTRATION PRE EVALUATION STEPS
FLOW OF REGISTRATIONEVALUATION STEPS
APPLICANT
COMPLETEDOC
EVALUATION TEAM
SAFETY, EFFICACY,TECHNOLOGY,
LABELINGEVALUATION
REJECTION
APPROVAL
REGISTRATION DATA
APPEAL
HEARING
ADDITIONAL DATA
NATIONAL COMMITTEEOF TRAD. DRUG. & FS
EVALUATION
EVALUATION / REEVALUATION
CRITERIA
TECHNICAL EVALUATION& RECOMMENDATION
REGULARMEETING
CLAIM LEVEL
A. General ClaimSupported by: At least has one of these references:
– Pharmacopoeia– Monograph or “Materia Medika”– 3 difference references on traditional medication history– It has been approved for being used in one country
Or scientific data– Descriptive study, case studies or report from relevant expert
committee
Example : “To help maintaining liver function” “ Traditionally use for …..”
Product In
EVALUATION OF
B. Moderate ClaimSupported by: At least have two of these references:
– Pharmacopoeia– Monograph or “Materia Medika”– 3 difference references on traditional medication history– It has been approved for being used in one country
Or Scientific data:– Analytical study including epidemiological cohort study and
case control or– Multiple time serial study without or with intervention
including population study in one country and inter country
Example : “To help recovery stamina”
Product In
EVALUATION OF
CLAIM LEVEL
CLAIM LEVEL
C. High ClaimSupported by:
– Systematic review from all of Randomized Controlled Trial (RCT), which lead to indifferent significantly result of clinical trial, (meta-analysis)
– Double Blind Randomized Controlled Trial
Example : “For Treatment of hypertension”
“For Treatment of erectile disfunction”
Product In
EVALUATION OF
PRODUCT SHOULD ACHIEVE QUALITY, EFFICACY AND SAFETY STANDARD
THERAPEUTICAL EFFECT IS REACHED IF APPROPRIATELY USED AS INDICATED
Product In
EVALUATION OF
1. PRECLINICAL TRIAL
a. Toxicity test (safety test)
b. Pharmacodynamic test (efficacy test)
2. PHARMACEUTICAL TECHNOLOGY
3. CLINICAL TRIAL
1. PRECLINICAL TRIAL
a. Toxicity test (safety test)
b. Pharmacodynamic test (efficacy test)
2. PHARMACEUTICAL TECHNOLOGY
3. CLINICAL TRIAL
Responsibility and true Research protocol
Ethical clearance
Responsibility and true Research protocol
Ethical clearance
RESEARCH SUPPORTRESEARCH SUPPORT
Product In
EVALUATION OF
STEPS FROM TRADITIONAL MEDICINE INTO PHYTOPHARMACA
1. PRECLINICAL TRIAL :a. Toxicity test/Safety :
Acute toxicity test : to decide an acute potencial toxicity/LD50, clinical disorders, toxicological spectrum effect and lethal mechanismLongterm toxicity test : to study toxic effect of traditional medicine long term usage
b. Pharmacodynamic test/Efficacy : to study toxic effect of the traditional drugs-sample. Experiment methods are perfomed on expected therapeutic activity. Animal experiment (in vivo) and specimen (in vitro) is perfomed in a healthy animal or unhealthy-manipulated animal. Observation of expected respon after treatment (can also be observed in another respon)
2.PHARMACEUTICAL TECHNOLOGY : to standardized Phytopharmaca product (simplisia, ekstract, dosage form, standard parameter of quality of raw material, extract, dosage form).
3. CLINICAL TRIAL :Clinical trial conducted in compliance with the requirement to GCP (Good Clinical Practise)Design to be used are : Randomized controlled trial
Product In
EVALUATION OF
Long term toxicity testLong term toxicity test
Expected Period of Clinical Use
Administration Period for The Toxicity Study
Single dosage or repeated administration for less than 1 week
2 weeks to 1 month
Repeated administration, between 1 to 4 weeks
4 weeks to 3 months
Repeated administration, between 1 to 6 months
3 – 9 months
Long term repeated administration for more than 6 months
9 – 12 months
Product In
EVALUATION OF
OBAT HERBAL TERSTANDAR
Product In
EVALUATION OF
FITOFARMAKA (1)
Product In
EVALUATION OF
Product In
EVALUATION OF
FITOFARMAKA (2)
Product In
EVALUATION OF
FITOFARMAKA (3)
Product In
EVALUATION OF
FITOFARMAKA (4)
Product In
EVALUATION OF
FITOFARMAKA (5)
