REGULATORY FRAMEWORK
Jakarta, 9-10 September 2014
Direktorat Standardisasi Obat Tradisional,
Kosmetik dan Produk Komplemen
Badan Pengawas Obat dan Makanan
2017
JAMU, OBAT HERBAL
TERSTANDAR, FITOFARMAKA
DAN KONDISI GLOBAL
Pengelompokkan Obat Bahan Alam
(Peraturan Kepala Badan POM No.HK.00.05.4.2411 Tahun 2004
Tentang Ketentuan Pokok Pengelompokkan dan Penandaan
Obat Bahan Alam Indonesia).
OBAT BAHAN
ALAM
INDONESIA
JAMU
OBAT HERBAL
TERSTANDAR
FITOFARMAKA
Catatan :
•
Bukti dukung berasal dari bukti
empiris {berdasarkan riwayat turun
temurun penggunaan obat bahan
alam (bagian tertentu atau
keseluruhan bagian tumbuhan)
untuk tujuan tertentu}
•
Merupakan wadah sementara
jamu
(yang
memiliki bukti empiris) sebelum menuju
fitofarmaka
•
Bukti dukung berasal dari uji pada hewan coba.
•
Penggunaan hewan coba pada tahapan uji pada
dasarnya untuk melihat
profil awal
(toksisitas
dan farmakodinamik/khasiat). Dan untuk
pemastian profil keamanan-khasiat selanjutnya
dilakukan tahap uji pada manusia.
•
Untuk OHT dikarenakan sudah memiliki data
empiris, penguatan melalui uji praklinik
(toksisitas dan farmakodinamik) dapat diterima.
•
Dapat berasal dari jamu (dengan bukti
dukung empiris) maupun dari non
jamu (non empiris).
•
Bukti dukung berasal dari uji pada
hewan coba dan uji pada manusia.
•
Fleksibilitas yang diberikan
Data toksisitas sub kronik dan kronik bisa diabaikan
(
case by case
)
Fase I bisa diabaikan (
case by case
)
Fase II dan III bisa digabung (
case by case
)
•
Kendala lambatnya penambahan jumlah fitofarmaka
kurangnya kompetensi industri/pelaku di bidang uji
klinik (misal metodologi diuji pada hewan coba dan
pada manusia)
perlunya upaya dan biaya yang lebih
industri/pelaku sudah merasa nyaman berada pada
kelompok OHT
KONSEP EMPIRIS
Obat bahan alam terbagi menjadi 2 (dua) yaitu
1. Traditional medicine (di Indonesia
dianalogikan dengan Jamu) dengan bukti
dukung empiris. Klim indikasi biasa diawali
dengan Traditionally used for... dan
2. Herbal medicine (di Indonesia dianalogikan
dengan Fitofarmaka) dengan bukti dukung
ilmiah (uji pada hewan coba dan pada
manusia)
KONSEP DI GLOBAL PEMENUHAN DATA
DALAM PENGEMBANGAN
1. Berikut gambaran obat bahan alam yang masih
berbasis pada penggunaan tradisional maupun
setelah ada perubahan dari penggunaan
2. Kondisi/persyaratan tersebut diatas juga
diterapkan oleh negara-negara di timur
tengah dan tercantum pada
Guidelines on
minimum requirements for the registration of
herbal medicinal products in the Eastern
3
. Bagaimana dengan di ASEAN
Type of TM claim
Scope
Examples to illustrate the scope
(as determined by the regulatory
authority of each Member State)
Traditional
Health
Use
Traditionally used for general health maintenance or enhancement
• Traditionally used to maintain health for people above 40 yrs old
• Tonic traditionally used to restore energy and health in women after childbirth/puerperium
• Tonic traditionally used to strengthen body by nourishing blood and invigorating vital energy
Traditional
Treatment
Traditionally used to relieve or alleviate a symptom, or treat a disease or medical condition according to the principles of traditional medicine, with the exception of the prohibited diseases according to each Member State
To prevent/stop/slow down the progress of a mild or self-limiting disease or medical condition, based on principles of traditional medicine
• A Traditional medicine for dizziness/vomiting during travel in car, boat and airplane
• Traditionally used to prevent cold or flu
• Traditionally used to relieve cold and sore throat
• Traditionally used to treat stomachache
• Traditionally used to treat constipation
• A traditional medicine to relieve itchiness
Scientifically
Established
Treatment
To relieve a symptom or treat a disease, disorder or medical condition substantiated by scientific evidence, which corroborates TM principles*
*as determined by the regulatory authority of each Member State
• For treatment of hypertension
• To treat or relieve arthritis
• Used to lower blood pressure
• Used to reduce blood sugar
16
Jenis Klaim TM Level bukti Kriteria Well-documented Untuk klaim TM
Bukti untuk mendukung klaim TM
Traditional Health Use
Evidence from documented traditional use and knowledge
- Claims for general health maintenance or enhancement are documented in TM references
- In accordance with TM principles and practice
Evidence of documented traditional use or history of use that may be found in the following:
Classical TM Texts
Pharmacopoeias and Monographs Reference Textbooks/Journals Traditional Treatment Evidence from documented traditional treatment
- Claims for treatment and prevention are documented in TM references - In accordance with TM principles and practice
Evidence of documented history of traditional treatment that may be found in the following:
Classical TM Texts
Pharmacopoeias and Monographs Reference Textbooks/Journals Scientifically
Established Treatment
Scientific data and TM principles
- Claims for treatment supported by scientific data
(such as in vitro, in vivo, epidemiological and/or
human intervention studies)
- In accordance with TM principles and practice
Compulsory evidence:
Substantiation of TM claims based on scientific data as required by the regulatory authority to be conducted on finished product or ingredient(s).Justification will have to be provided to the regulatory authority if evidence provided is based on ingredient
At least 1 additional evidence:
Evidence of documented history of traditional treatment that may be found in the following:
Classical TM Texts
Pharmacopoeias and Monographs Reference Textbooks/Journals
Note: Refere es that are used to su sta tiate a TM lai i lude ASEAN Me er States’ offi ial phar a opoeias a d o ographs.
Decision tree on the evidence required to support the
different types of TM claims
A proposed TM claim
Traditional Health Use Claim Traditional Treatment Claim Scientifically Established Treatment Claim Refer to Table 2 and Sections 4.2 and 4.3
Evidence of documented
traditional use or history
of use that may be found
in the following:
•
Classical TM Text
•
Pharmacopoeias and
Monographs
•
Reference Textbooks /
Journals
Evidence of documented
history of traditional
treatment that may be
found in the following:
•
Classical TM Text
•
Pharmacopoeias and
Monographs
•
Reference Textbooks /
Journals
Compulsory evidence:
Substantiation of TM claims based on scientific data, as required by the regulatory authority to be conducted on finished product or ingredient(s). Justification will have to be provided to the regulatory authority if evidence provided is based on ingredient
At least 1 additional evidence:
Evidence of documented history of traditional treatment that may be found in the following:
• •Classical TM Texts
• •Pharmacopoeias and Monographs
• •Reference Textbooks/Journals
Does it meet the criteria of well documented TM
claim based on substantiation of
evidence?
Does it meet the criteria of well documented TM
claim based on substantiation of
evidence?
Does it meet the criteria of well documented TM
claim based on substantiation of
evidence?
Not a well-documented
Traditional Health Use
Claim
NO
Not a well-documented
Traditional Treatment
Claim
NO
Not a well-documented Scientifically Established Treatment Claim NO YES Traditional Health Use Claim Traditional
Treatment Claim Scientifically Established
Treatment Claim YES
Type of HS
claim
Scope
Examples to illustrate the scope
- as determined by the regulatory
authority of each Member State
General or
Nutritional
For Nutritional Support and General Health
Maintenance. Benefits derived from supplementation
beyond
a perso ’s daily dietary i take.
• Supple e ts utritio
• Supports healthy gro th a d
Development
• Nourishes the ody
• Relie es ge eral tired ess, eak ess
• Helps to ai tai good health
Functional
Relate to a positive contribution to health or to
the improvement of a function or to modifying
or preserving health in the context of the total
diet on normal functions or biological activities
of the body.
Maintains or enhances structure or function of
the body, excluding disease related claims.
Supports health and to relieve/reduce/
lessen/ease minor body discomforts in some
physiological processes (e.g. ageing, Menopause,
pregnancy)*.
*as determined by the regulatory authority of each
Member State
• Mai tai s/Supports healthy joi ts
• Mai tai s/Supports i
u ity
• Mai tai s healthy li er fu tio
• Mai tai s/Supports alert ess
• Mai tai s/Supports e tal
performance
• Pro otes healthy ski
• Helps to relie e post
-menopausal
discomforts
• Aids i digestio to relie e i digestio
•
Bifidobacteria in product A helps to
improve slow transit system in 14 days
• Supports health i agei g
• Supports health i e opause
• Supports health i preg a y
Type of
HS claim
Scope
Examples to illustrate the scope
- as determined by the
regulatory
authority of each Member State
Disease
Risk
Reduction
Significantly altering or reducing a
risk factor of
a disease or health related
condition*.
*as determined by the regulatory
authority of each Member
State
• Helps to redu e risk of
osteoporosis by
strengthening bone
• Helps to redu e the risk of
OBAT HERBAL
REGISTRASI OHT
•
Protokol Uji Praklinik diajukan ke
BPOM untuk persetujuan
•
Data praklinik sebagai bukti dukung
khasiat keamanan registrasi Obat
Herbal Terstandar
REGISTRASI FITOFARMAKA
•
Data praklinik bisa berasal dari data praklinik
Obat Herbal Terstandar (namun bila perlu
disesuaikan) atau data praklinik baru (tidak
perlu protokol uji praklinik, tidak perlu
dimintakan persetujuan BPOM)
•
Pengajuan persetujuan pelaksanaan uji klinik
diserahkan dokumen Protokol Uji Klinik,
Informed concern
, dan
Investigator Brochure
)
•
Data klinik sebagai bukti dukung khasiat
keamanan registrasi fitofarmaka
CONTOH KEKURANGAN SAAT EVALUASI DOKUMEN & PROTOKOL UJI KLINIK
UJI PRA KLINIK
UJI KLINIK
1.
Data uji farmakodinamik belum
menggambarkan penyakit yang
dikondisikan namun sudah ada
tindakan/prosedur lanjutan.
2.
Data keamanan berupa toksisitas sub
kronis dan teratogenik yang masih
memerlukan klarifikasi lebih lanjut
dikarenakan misalnya paparan
histologi yang inkonsisten
3.
Kurangnya jumlah hewan coba yang
digunakan
4.
Terdapat kejadian serius di ginjal dan
lever di semua hewan coba yang
digunakan, baik di mencit maupun di
kelinci
1.
Metodologi uji yang kurang
sesuai
2.
Kriteria inklusi dan eksklusi yang
belum sesuai
3.
Jumlah subjek yang kurang
4.
Endpoint efikasi tidak menjawab
apa yang menjadi tujuan uji
