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ASEAN : Association of South East Asian Nations. Brunei Cambodia Indonesia Lao People’s Democratic Republic Malaysia Myanmar Philippines Singapore Thailand Vietnam. Drug Registration in ASEAN : Dr.G.V.R.Joseph. Drug registration :

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ASEAN : Association of South East Asian Nations

Brunei Cambodia

Indonesia Lao People’s Democratic Republic

Malaysia Myanmar

Philippines Singapore

Thailand Vietnam

Drug Registration in ASEAN : Dr.G.V.R.Joseph

slide3
Drug registration :

Permission granted by the relevant state authority to use and distribute a certain drugs;

Main aim of registration is to ensure that the users get only safe, effective drugs of high quality.

Drug Registration in ASEAN : Dr.G.V.R.Joseph

ayush product exports to asean countries
AYUSH Product Exports to ASEAN Countries

Year Value in mn.US$

2004 8.23

2005 10.58

2006 21.58

2007 25.18

2008 38.13

Drug Registration in ASEAN : Dr.G.V.R.Joseph

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Major Exports :

Guar gum

Menthol

Chyawanprash

Herbal extracts etc.

Drug Registration in ASEAN : Dr.G.V.R.Joseph

format for drug registration
Format for Drug Registration :

ACTD - Common Technical Dossier

Common application format that will be submitted to ASEAN regulatory authorities for the registration of pharmaceutical products for human use.

Even though some of the Individual ASEAN Countries have their own drug registration formats, all ASEAN countries accept the ACTD.

Countries like Brunei Darussalam, Cambodia, Myanmar, Thailand, does not have any separate drug registration format but follow ACTD.

Drug Registration in ASEAN : Dr.G.V.R.Joseph

brunei
Brunei

Brunei Darussalam :

There is separate cell for Pharmaceutical services and the Department of Pharmaceutical service is mainly responsible for executing the control of drugs. There are more than 3500 Pharmaceutical products are registered. For the registration of Pharmaceutical products one has to submit the detailed monograph of the said product giving the details of the product pertaining to its Pharmacology,Pharmacokinetics,Toxicology,Biopharmaceutics,

Clinical Pharmacology, Clinical efficacy, Safety etc. as required for CTD and any other supporting documents like Clinical trial, comparative studies.

Drug Registration in ASEAN : Dr.G.V.R.Joseph

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Cambodia :

National policy on TM/CAM was issued in 1996 and regulations were issued in 1998. Regulation of herbal medicines in Cambodia was introduced in 1998. Herbal medicines are regulated as over-the-counter medicines and for self-medication only.

Cambodia follows the common ASEAN CTD for registration of Pharmaceutical Product for Human use. There are more than 48 registered herbal medicines; however, none of them are included on National essential drug list. Herbal medicines in Cambodia are sold in pharmacies as over-the-counter medicines, in special outlets, by licensed practitioners and without restriction.

Drug Registration in ASEAN : Dr.G.V.R.Joseph

slide9
Indonesia :

“National Policy on Development of Traditional Medicine” was issued in 2000. Laws and regulations on TM/CAM were first issued in 1993. Through a separate law for herbal medicines, regulation was established in 1993, and updated in 1994 and 1995. Herbal medicines are regulated as over-the-counter medicines, as a separate regulatory category and as traditional medicines. There are approx. 8632 registered herbal medicines in Indonesia. No herbal medicines are included on a National essential drug list. Herbal medicines are sold in pharmacies as over-the-counter medicines, in special outlets, by licensed practitioners and without restriction. Indonesia has its own drug registration format and also follows ASEAN CTD.

Drug Registration in ASEAN : Dr.G.V.R.Joseph

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Lao People’s Democratic Republic :

National policy on TM/CAM was included in the National Drug Policy issued in 1998. Regulations on herbal medicine in the Lao People’s Democratic Republic were issued in 2002; Herbal medicines are regulated as over-the-counter medicines. In the Lao People’s Democratic Republic herbal medicines are sold in pharmacies as over-the-counter medicines and by licensed practitioners. Lao PDR has its own has drug registration format and also follows ASEAN CTD.

Drug Registration in ASEAN : Dr.G.V.R.Joseph

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Malaysia :

National policy on TM/CAM, which was launched in the year 2001. The registration and licensing of TM/CAM is legislated through the Control of Drugs and Cosmetics Regulations 1984. Regulation for traditional medicines, including herbal medicines and dietary supplements formed part of the Control of Drugs and Cosmetics Regulations in 1984. Traditional medicines are allowed to be sold as over-the-counter medicines. As of December 2003, approximately 1200 traditional medicines, including herbal products are registered and regulated by DCA. However, none of these products are included on the National essential drug list. In Malaysia, herbal medicines are sold in pharmacies as over-the-counter drugs without any restrictions. For registering Pharmaceutical product on-line drug registration facility is available.

Drug Registration in ASEAN : Dr.G.V.R.Joseph

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Myanmar :

National policy on TM/CAM was issued in 1993.Myanmar follows the common ASEAN CTD for the registration of Pharmaceutical Products for human use. There are approx 3,678 registered traditional medicines in Myanmar. In Myanmar, the Traditional Medicines Drug law was enacted in 1996 to ensure the quality, safety and efficacy of traditional medicines. The regulatory statues used for herbal medicine are over-the-counter medicines and herbal medicine as a separate category. Herbal medicines are sold in pharmacies as over-the-counter medicines and without restriction

Drug Registration in ASEAN : Dr.G.V.R.Joseph

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Philippines :

National policy on TM/CAM was issued in 1997. The regulations on herbal medicines were issued in 1984; these regulations are separate form those for conventional pharmaceuticals. Herbal medicines are regulated as over-the-counter medicines. The Philippines has separate registration system for herbal medicines; however, the number of registered herbal medicines is not available. In the Philippines, herbal medicines are sold in pharmacies as over-the-counter medicines and in special outlets. Philippines has its own drug registration formats and also follows ASEAN CTD.

Drug Registration in ASEAN : Dr.G.V.R.Joseph

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Singapore :

National policy on TM/CAM was issued in 1995. There are National regulations on herbal medicines in Singapore. Herbal medicine is regulated as over-the-counter medicines. Singapore has its own drug registration format and follows common ASEAN CTD. There are no restrictions on the sale of herbal medicines, as long as they comply with the National regulations.

Drug Registration in ASEAN : Dr.G.V.R.Joseph

slide15
Vietnam :

National policy on TM/CAM is currently being developed. Laws and regulations on TM/CAM were issued in 1989.Herbal medicines are regulated as prescription and over-the-counter medicines. Vietnam has its own drug registration format and also follows ASEAN CTD. There are approx. 1573 registered herbal medicines in Vietnam; 267 herbal medicines are included on the National essential medicines list of 1996. In Vietnam, herbal medicines are sold in pharmacies as prescription and over-the-counter medicines, in special outlets and by licensed practitioners.

Drug Registration in ASEAN : Dr.G.V.R.Joseph

slide16
Thailand :

The National policy and programme on traditional medicine was issued in 1993, when the Institute of Thai Traditional Medicine was officially established under the Department of Medical Services. National laws and regulations on traditional medicines were issued in 1967 under the Drug Act B.E. 2510, which is divided into two parts covering modern and traditional medicines. Registered traditional medicines can be divided into prescription medicines or over-the-counter medicines. Medical, health and structure/function claims may be made about herbal medicines. Thailand has its own drug registration format and also follows ASEAN CTD. There are more than 2000 herbal medicines registered in Thailand; a total of more about 20 herbal preparations are included in the National list of essential drugs, A.D. 1999. Herbal medicines are sold in pharmacies as over-the-counter drugs, or licensed practitioners may make their own herbal preparations and sell them to patients. For registered household herbal medicines, there are no restrictions on sales.

Drug Registration in ASEAN : Dr.G.V.R.Joseph

ctd format
CTD Format:

Part I : Table of Content Administrative Information and Prescribing Information

Section A: Introduction

Section B: Overall ASEAN Common Technical Dossier Table of Contents

Section C: Documents required for registration (for example, application forms,

labeling, Product Data Sheet, prescribing information)

Part II : Quality Document

Section A: Table of Contents

Section B: Quality Overall Summary

Section C: Body of Data

Part III : Nonclinical Document

Section A: Table of Contents

Section B: Nonclinical Overview

Section C: Nonclinical Written and Tabulated Summaries

1. Table of Contents

2. Pharmacology

3. Pharmacokinetics

4. Toxicology

Drug Registration in ASEAN : Dr.G.V.R.Joseph

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CTD format cont…

Section D: Nonclinical Study Reports

1. Table of Contents

2. Pharmacology

3. Pharmacokinetics

4. Toxicology

Part IV : Clinical Document

Section A: Table of Contents

Section B: Clinical Overview

Section C: Clinical Summary

1. Summary of Biopharmaceutics and Associated Analytical Methods

2. Summary of Clinical Pharmacology Studies

3. Summary of Clinical Efficacy

4. Summary of Clinical Safety

5. Synopses of Individual Studies

Section D: Tabular Listing of All Clinical Studies

Section E: Clinical Study Reports

Section F: List of Key Literature References

Drug Registration in ASEAN : Dr.G.V.R.Joseph

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ASEAN Countries

having their own

Registration formats

Drug Registration in ASEAN : Dr.G.V.R.Joseph

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ASEAN Countries having their own Registration formats :

Indonesia:Traditional Medicines Name Package size Registration Number, name and industry address (at least name of city and country) Composition (species name of raw ingredient) Effects/Usefulness Usage Warning and contra- indication (if exist) Production Code Number Expired Date level of production/ Standard Operational Procedure; Utility or machine Source of available raw ingredients Quality Evaluation of Raw Ingredients Methods and Test Result of Stability/Durability

Drug Registration in ASEAN : Dr.G.V.R.Joseph

slide21

ASEAN Countries having their own Registration formats :

Lao People’s Democratic Republic:

Name and address of the local manufacturer,

importer

The International Non-Proprietary Name (INN) of the active ingredients)

Brand name (if any)

Composition of the product (formulation)

Unit price in US$

Dosage strength

Dosage form

Storage Condition

Shelf-life

Primary packaging

Size of packaging

Dispensing category (prescription or over-the counter drug)

Product Description

Pharmacological category (according to Lao EDL)

Contra-indications

Side/Adverse effects

Certificate of Analysis of the Finished Product

Assay method and other test procedure for the finished product

Manufacturing Method and Process of Production,

Samples in Market or Commercial Presentation

Labeling Materials Including Label, Package Leaflet, etc.

Certificate of Drug Registration Issued by the Regulatory Authority of the manufacturing country

List of countries in which the product is registered

Drug Registration in ASEAN : Dr.G.V.R.Joseph

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ASEAN Countries having their own Registration formats :

Malaysia:

PRODUCT VALIDATION:

Product Name:

Dosage Form:

Active Ingredients:

Substance Name: Active Ingredients, strength of substance, origin either plant, animal, others

Excipient:Substance Name: strength of substance, origin either plant, animal , others.

Any porcine materials: yes or no

Manufacturer: product classification

SECTION –A:

PRODUCT PARTICULARS:

Name of Product

Product description

Dosage form

Active Substance

Excipient substance

Product indication/usage:

Dose/use instruction:

contraindication:

Warning/precautions:

Drug Interactions:

Side Effects:

Signs and symptoms of overdose:

Storage Condition:

Shelf life:

Therapeutic code.

SECTION – B:

Batch Manufacturing formula

Attachment of Batch manufacturing formula documentation if any:

Manufacturing process:

Attachment of Manufacturing process documentation if any:

In process Quality control

Drug Registration in ASEAN : Dr.G.V.R.Joseph

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Malaysian Drug Registration format Cont..

Attachment of finished product specification documentation:

(details of specification and quality control test for finished product which

include a list of tests and specifications and state the limits or criteria of

acceptance for each test or specification).

Attachment of Stability Data Documentation (for two batches)

SECTION – C:

Pack size : weight, volume, quantity,

Immediate container type:

Container type description:

Barcode/serial no.

Recommended Distributors price

Recommended Retail Price.

SECTION- D:

Mock up for Immediate Container

Mock up for outer container

Proposed package insert patient information leaflet)

SECTION – E:

Product owner

Manufacturer

other Manufacturer involved if any

Store address (if any)

SECTION- F:

Letter of Authorization from product owner

Is the active substances) patented in Malaysia : yes or no

Certificate of Pharmaceutical product (CPP):

Certificate of Free Sale(CFS): Certificate of Good Manufacturing Practice (GMP):

summary of product characteristics product data sheet if any):

Patient information leaflet (PIL) if any:

Attachment of Protocol of Analysis if any:

Attachment of Certificate of analysis for two batches:

Attachment of Specifications and Certificate of analysis of active ingredient if any:

other supporting Document if any:

Drug Registration in ASEAN : Dr.G.V.R.Joseph

slide24

ASEAN Countries having their own Registration formats :

APPLICATION FOR REGISTRATION OF PHARMACEUTICAL PRODUCT

To be filled up by the applicant

A.COMPANY APPLICANT

Company Name:

Complete Address:

Contact Numbers:

Type of establishment

Complete Name:

Complete Address:

B.TYPE OF APPLICATION

INITIAL REGISTRATION

RENEWAL REGISTRATION

MONITORED RELEASE EXTENSION

C.COMPLETE INFORMATION REGARDING THE PRODUCT

1. Generic Name (s):

2. Brand Name, if any:

3. Dosage Strength:

4. Dosage Form:

5. Route of Administration:

6. Pharmacologic Category:

7. Classification: Rx (Prescription Drug)

OTC (Over-the-Counter

Restricted/Regulated

Essential Drug List (EDL)

8. Claimed Shelf Life

9. Storage Condition

10. Primary Packaging (Market/Commercial Presentation):

11. Suggested Retail Price:

12. Reference Monograph:

Official:

Non-Official

Philippines:

Drug Registration in ASEAN : Dr.G.V.R.Joseph

slide25

ASEAN Countries having their own Registration formats :

Singapore:

Forensic Classification

Registration Status in Other Countries

Drug Registration in ASEAN : Dr.G.V.R.Joseph

slide26

ASEAN Countries having their own Registration formats :

Vietnam:

Summary of product characteristics.

Free Sale Certificate.

GMP Certificate.

Manufacturing process (fully detailed).

Quality specifications and analytical methods (fully detailed).

Certificate of analysis released by the manufacturer.

Report of stability studies.

Labeling samples.

Product samples.

Study report on toxicology.

Study report on experimental pharmacology.

Study report on pharmaco-kinetics and bioavailability.

Study report on clinical pharmacology.

Effects, indications, contra-indications, dosage, toxicity,

side-effects and the safety of that products

Drug Registration in ASEAN : Dr.G.V.R.Joseph

slide27

Countries having separate Herbal Medicine Registration format

Drug Registration in ASEAN : Dr.G.V.R.Joseph

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Countries having separate Herbal Medicine Registration format Cont..

Drug Registration in ASEAN : Dr.G.V.R.Joseph

slide29

Countries having separate Herbal Medicine Registration format Cont..

Drug Registration in ASEAN : Dr.G.V.R.Joseph

slide30

Comparative Chart with respect to details of Plant Monographs in standard books

Drug Registration in ASEAN : Dr.G.V.R.Joseph

slide31

Comparative Chart with respect to details of plant Monographs in standard books Cont..

Drug Registration in ASEAN : Dr.G.V.R.Joseph

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Comparative Chart with respect to details of plant Monographs in standard books Cont..

Drug Registration in ASEAN : Dr.G.V.R.Joseph

slide33

Comparative Chart with respect to details of Plant Monographs in standard books Cont..

Drug Registration in ASEAN : Dr.G.V.R.Joseph

slide34

Abbreviations:

WHO - World Health Organization

AHP - American Herbal Pharmacopoeia and Therapeutic Compendium

ESCOP - German Commission E Monograph

PDR - Physician Desk Reference for Herbals

ICMR - Indian Council of Medical Research

EMEA - European Medicines Evaluation Agency

BHC – British Herbal Compendium

BHP – British Herbal Pharmacopoeia

SLM – Sri Lanka Monograph

IP – Indian Pharmacopoeia

UP - Unani Pharmacopoeia

API - Ayurvedic Pharmacopoeia

HP - Homeopathic Pharmacopoeia

IHP - Indian Herbal Pharmacopoeia

Comparative Chart with respect to details of plant Monographs in standard books Cont..

Drug Registration in ASEAN : Dr.G.V.R.Joseph

slide35

Thank You

Drug Registration in ASEAN : Dr.G.V.R.Joseph