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 :

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

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

Major Exports :

Guar gum

Menthol

Chyawanprash

Herbal extracts etc.

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

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 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

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

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

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

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

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

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

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

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
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:
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

 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

ASEAN Countries

having their own

Registration formats

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

 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

 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

 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

 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

 ASEAN Countries having their own Registration formats :

Philippines:
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

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

 ASEAN Countries having their own Registration formats :
Singapore:
Company Particulars

Company shall be based and registered in Singapore

Applicant particulars
Application Details
Type of Application

Type of Product

Type of Dossier

Reference Product

Product
* intended for export
Product
*
Information

Packaging, Shelf Life & Storage Condition

Forensic Classification

Registration Status in Other Countries

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

 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

Countries having separate Herbal Medicine Registration format
S.No NAME OF THE COUNTRY PHILIPPINES MALAYSIA ACTD

1 Name of Herbal or Homeopathic + + +

Medicine
2 Dosage Form + + +

3 Strength + + +

4 Color + + +

5 Commercial Presentations + + +

6 Country of Origin + +

7 Name of Applicant + + +

8 Business Address + + +
Phone
Fax
e-mail:

9 Name of Manufacturer + + +
Premises Address + + +
Postal Address
Phone
Fax
e-mail

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

 Countries having separate Herbal Medicine Registration format Cont..
10 Name of Local Agent +

11 Business Address +
Phone
Fax
e-mail

12 Product details + + +

13 List all active ingredients + + +

14 List all non active ingredients + + +

15 Origin or source of the raw materials + + +

16 Summary of the manufacturing + + +

procedure.

17 Shelf-life of the medicine. + + +

18 Certificate of analysis + + +

19 Toxicological, pharmacological and + + +

clinical information, as well as
therapeutic effects of the herbal
preparation

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

 Countries having separate Herbal Medicine Registration format Cont..

20 Indication + + +

21 Dosage and administration + + +

22 Contraindications + + +

23 Adverse reactions/Side effect + + +

24 Precautions + + +

25 Use in pregnancy and lactation +

26 Treatment of over dosage + + +

27 Interactions with other drugs or food + + +

28 Storage conditions + + +

29 Application fee paid

30 Declaration by applicant +

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

 Comparative Chart with respect to details of Plant Monographs in standard books
S. Headings WHO AHP ESCOP PD EMEA BH BH SL IP API UP HP IHP ICMR
No. R community C P M
monograph
& Quality
tests

01 Definition √ √ √ √ √ √ √ √ √ √ √ √

02 Nomenclature √ √ √ √ √ √ √ √ √

a. Botanical √ √ √ √ √ √ √ √ √
Nomenclature

b. Botanical Family √ √ √ √ √ √ √ √ √

03 Synonyms √ √ √ √ √ √ √ √ √ √

04 Selected vernacular √ √ √ √ √ √ √
names/ Common
Name

05 Description √ √ √ √ √ √ √ √

06 History √ √ √

07 Plant Material of √ √
interest

i. General Appearance √ √ √ √

Botanical √ √ √
Identification

ii Organoleptic √ √ √ √
properties

Macroscopic √ √ √ √ √ √ √ √ √
Identification

iii Microscopic √ √ √ √ √ √ √ √ √ √ √
characteristics

iv Powdered plant √ √ √ √ √ √
material

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

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

S. No. Headings WHO AHP ESCOP PDR EMEA BH BHP SLM IP API UP HP IHP ICM
community C R
monograph &
Quality tests

08 Commercial Sources & √

Handling

i Collection √ √

ii Cultivation √ √

iii Drying √

iv Handling √ √

v Storage √ √ √

vi Adulterants √ √

vii Preparations √ √

09 Geographical √ √ √ √ √ √
distribution

10 General identity tests √ √ √ √ √

11 Purity tests √ √ √ √

i. Microbiology √ √ √ √

ii. Total Ash √ √ √ √ √ √

iii Acid-insoluble ash √ √ √ √ √ √ √

iv. Water-soluble extractive √ √ √ √ √ √

v. Alcohol-soluble √ √ √ √ √ √
extractive

vi Foreign Organic Matter √ √ √ √ √ √

vii Loss on Drying √ √ √

viii. Pesticide residues √ √

ix Heavy Metals √ √ √ √

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

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

S. Headings WHO AHP ESCOP PD EMEA BH BH SL IP API UP HP IHP ICMR

No. R community C P M
monograph
& Quality
tests

x Radioactive residues √ √

xi Other purity tests √

12 Chemical assays √ √ √ √ √ √ √ √

13 Major Chemical √ √ √ √ √ √ √ √ √ √
constituents/
Constituents

14 Dosage forms √ √ √ √ √ √ √ √ √ √ √

15 Adulterants and √ √
Substitutes

16 Therapeutics √ √ √ √ √ √ √ √

a. Pharmacokinetics √ √ √

b. Pharmacodynamics √ √ √

c. Preclinical Safety √
Data

17 Medicinal uses √ √ √ √ √ √

i. Uses supported by √ √ √ √
clinical data

ii. Uses described in √ √ √ √

pharmacopoeias and
in traditional
systems of medicine

iii Uses described in √

folk medicine, not
supported by
experimental or
clinical data

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

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

S. Headings WHO AHP ESCOP PD EMEA BH BH SL IP API UP HP IHP ICMR

No. R community C P M
monograph
& Quality
tests

18 Pharmacology √ √ √ √ √ √ √ √

a. Experimental √ √
pharmacology

b. Clinical √ √ √ √
pharmacology

19 Contraindications √ √ √ √ √

20 Warnings √ √

21 Pregnancy and √ √ √
lactation

22 Effects on ability to √ √
drive and use
machines

23 Overdose √ √ √

24. Precautions √ √ √ √ √ √ √

a. Carcinogenesis, √ √
mutagenesis,
impairment of
fertility

b. Other precautions √

c. Adverse reactions √ √ √ √ √

d. Interactions √ √

e. Posology √ √

f. Toxicology √ √

25 Regulatory Status √ √

26 References √ √ √ √ √ √

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

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

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

Thank You

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