Transcript Document 7282706

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-thecounter 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 overthe-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-thecounter 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
Indonesia:
ASEAN Countries having their own Registration formats :
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
Malaysia:
ASEAN Countries having their own Registration formats :
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
Singapore:
ASEAN Countries having their own Registration formats :
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.
No.
Headings
WHO
AHP
ESCOP
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
√
√
√
Organoleptic
properties
√
EMEA
community
monograph
& Quality
tests
BH
C
BH
P
√
√
√
√
√
√
√
√
√
√
SL
M
√
IP
API
UP
HP
IHP
ICMR
√
√
√
√
√
√
√
√
√
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Botanical
Identification
ii
PD
R
√
Macroscopic
Identification
√
√
√
√
√
√
√
√
√
√
√
√
iii
Microscopic
characteristics
√
√
√
iv
Powdered plant
material
√
√
√
√
√
√
√
√
√
√
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√
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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
community
monograph &
Quality tests
BH
C
BHP
SLM
IP
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
08
API
UP
IHP
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Foreign Organic Matter
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√
√
√
√
vii
Loss on Drying
√
√
viii.
Pesticide residues
√
√
Heavy Metals
√
√
ix
HP
√
√
√
√
√
Drug Registration in ASEAN : Dr.G.V.R.Joseph
√
ICM
R
Comparative Chart with respect to details of plant Monographs in standard books Cont..
S.
No.
Headings
WHO
AHP
ESCOP
PD
R
EMEA
community
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
√
BH
C
BH
P
SL
M
IP
API
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√
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√
√
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UP
HP
IHP
ICMR
√
√
√
√
√
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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
PD
R
EMEA
community
monograph
& Quality
tests
BH
C
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
SL
M
IP
API
UP
HP
IHP
√
ICMR
√
√
√
√
√
√
√
√
√
√
√
√
√
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√
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BH
P
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Drug Registration in ASEAN : Dr.G.V.R.Joseph
Abbreviations:
WHO
AHP
ESCOP
PDR
ICMR
EMEA
BHC
BHP
SLM
IP
UP
API
HP
IHP
–
–
–
–
-
Comparative Chart with respect to details of plant Monographs in standard books Cont..
World Health Organization
American Herbal Pharmacopoeia and Therapeutic Compendium
German Commission E Monograph
Physician Desk Reference for Herbals
Indian Council of Medical Research
European Medicines Evaluation Agency
British Herbal Compendium
British Herbal Pharmacopoeia
Sri Lanka Monograph
Indian Pharmacopoeia
Unani Pharmacopoeia
Ayurvedic Pharmacopoeia
Homeopathic Pharmacopoeia
Indian Herbal Pharmacopoeia
Drug Registration in ASEAN : Dr.G.V.R.Joseph
Thank You
Drug Registration in ASEAN : Dr.G.V.R.Joseph