regulatory and ethical requirements for … hary wahyu-ppt.pdf · regulatory and ethical...
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13TH FERCAP International Conference
Sanur Beach Hotel, Sanur, Bali
Hary Wahyu T.
National Agency of Drug and Food Control Republic of Indonesia
REGULATORY AND ETHICAL
REQUIREMENTS FOR HERBAL
MEDICINE
Traditional medicine:
- Spesific for some countries
- It is sometimes accompanied by other traditional practice(s), e.g accupuncture, bekam (using chop), massage or others
- Sometimes used as complementary or alternative medicine
ASEAN Harmonization on TM
- Under AEC and Socio Culture pillars
- Harmonization on standards and technical requirements
INTRODUCTION (1)
INTRODUCTION (2)
Ref :
General guidelines for methodologies on research and evaluation of traditional medicine.
Geneva, World Health Organization, 2000 (document WHO/EDM/TRM/2000.)
• has a long history
• the sum total of knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures
• used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness
INTRODUCTION (3)
Single ingredient or in combination Derive from plants, animal, natural mineral Generation to generation According to Indonesia norms Contain no chemical(s)
Should get approval prior to marketing through pre market evaluation
By regulation
SIMILARITIES WITH DRUG
Raw materials sould be identified
Provide pharmacological effect
Supported by evidence(s)
Comply with Standards and
Technical requirements, such as
stability, GMP, GLP, GCP and
stability guideline
INTRODUCTION (4)
VS
Herbal
Traditional herbal
Traditional health use
Traditional treatment
Non traditional herbal
Non traditional
history
New non traditional claim
INTRODUCTION (5)
Traditional Claim Non Traditional Claim
INTRODUCTION (6)
Clearly identified, e.g : Location of plantation Content of compounds and its
quantity Method of preparation (e.g method
of extraction)
Non Traditional Claim
History of Use
Empirical data
Classical text Classical literature Pharmacopoeia
Scientific data
Preclinical data
Clinical data
Phase I Phase II clinical data Phase III clinical data Phase IV clinical data (if needed)
EVIDENCE(S) FOR CLAIM
Regulatory Framework for Product Placement (2)
Full dossier submission prior to marketing
Adm data
Safety data
Efficacy data
Quality data
Strong post market control
Pre market evaluation activities mostly done after the products in the market
Regulatory Framework for Clinical Trial (1)
Clinical Trial
Authori-zation (CTA)
Evaluate clinical trial documents and clinical trial product documents
Clinical trial document : Protocol, investigator brochure, Informed Consent , Investigator’s GCP certificate
Regulator approval to conduct clinical trial and to import trial product (if needed)
Official inspection by regulator to check the complience of related parties to GCP
To check documents, facilities, records, and any other resources related to the clinical trial
The objectives are to have quality and integrity data and to protect human subjects that participate in the clinical trial
Can be un-announced or announced GCP inspection
Regulatory Framework for Clinical Trial (2)
GCP
INSPECTION
The Need of CTA and GCP Inspection
Adequat
protocol
The data(s) meet
quality and integrity
requirements
The data(s) don’t
meet the quality and
integrity
requirements it
will bring to the
false evaluation
decision in the
registration process
CT conduct
comply to GCP
CT conduct
non comply to GCP
- Willing to have valid and credible clinical data
- Protection to the subject and investigator
2. Risk from
unreliable results Safety and efficacy
profil ??
Threatened people’s safety
Invetigational product
exposure 1. Risk on the subjects
Threaten subject’s safety
Design
CT conduct
CT conduct
Drug quality
Design Need review
Need review
Bias evaluation result
3. Non comply to GMP for IP
Clinical Trial Risk
Threatened subject’s safety