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

Outline :

Introduction

Evidences

Regulatory Framework

Risk on Clinical Trial

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 (1)

Listing or Registration

Registration

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