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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 :
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
Guar gum
Menthol
Chyawanprash
Herbal extracts etc.
Major Exports :
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
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
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
CTD format cont…
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:
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
ASEAN Countries having their own Registration formats :
Drug Registration in ASEAN : Dr.G.V.R.Joseph
Lao People’s Democratic Republic: Name and address of the local manufacturer,importerThe International Non-Proprietary Name (INN) of the active ingredients)Brand name (if any)Composition of the product (formulation)Unit price in US$Dosage strengthDosage formStorage ConditionShelf-lifePrimary packagingSize of packagingDispensing category (prescription or over-the counter drug)Product DescriptionPharmacological category (according to Lao EDL)Contra-indicationsSide/Adverse effectsCertificate of Analysis of the Finished ProductAssay method and other test procedure for the finished productManufacturing Method and Process of Production,Samples in Market or Commercial PresentationLabeling Materials Including Label, Package Leaflet, etc.Certificate of Drug Registration Issued by the Regulatory Authority of the manufacturing countryList of countries in which the product is registered
ASEAN Countries having their own Registration formats :
Drug Registration in ASEAN : Dr.G.V.R.Joseph
Malaysia:
PRODUCT VALIDATION:Product Name:Dosage Form:Active Ingredients:Substance Name: Active Ingredients, strength of substance, origin either plant, animal, othersExcipient:Substance Name: strength of substance, origin either plant, animal , others.Any porcine materials: yes or noManufacturer: product classificationSECTION –A:PRODUCT PARTICULARS:
Name of ProductProduct descriptionDosage formActive SubstanceExcipient substanceProduct 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 formulaAttachment of Batch manufacturing formula documentation if any:Manufacturing process:Attachment of Manufacturing process documentation if any:In process Quality control
ASEAN Countries having their own Registration formats :
Drug Registration in ASEAN : Dr.G.V.R.Joseph
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 priceRecommended Retail Price.SECTION- D:Mock up for Immediate ContainerMock up for outer containerProposed package insert patient information leaflet)SECTION – E:Product ownerManufacturerother Manufacturer involved if anyStore address (if any)SECTION- F:Letter of Authorization from product ownerIs the active substances) patented in Malaysia : yes or noCertificate 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:
Malaysian Drug Registration format Cont..
Drug Registration in ASEAN : Dr.G.V.R.Joseph
Philippines:ASEAN Countries having their own Registration formats :
Drug Registration in ASEAN : Dr.G.V.R.Joseph
APPLICATION FOR REGISTRATION OF PHARMACEUTICAL PRODUCTTo be filled up by the applicantA.COMPANY APPLICANTCompany Name:Complete Address:Contact Numbers:Type of establishmentComplete Name:Complete Address:B.TYPE OF APPLICATIONINITIAL REGISTRATIONRENEWAL REGISTRATIONMONITORED RELEASE EXTENSIONC.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-CounterRestricted/RegulatedEssential Drug List (EDL)
8. Claimed Shelf Life9. Storage Condition10. Primary Packaging (Market/Commercial Presentation):11. Suggested Retail Price:12. Reference Monograph:
Official:Non-Official
Company Particulars
Company shall be based and registered in Singapore
Applicant particulars
Application Details
Type of Application
Type of Product
* *
Reference Product
Product intended for export
Type of Dossier
Product Information
Singapore:
Packaging, Shelf Life & Storage Condition
Forensic Classification
Registration Status in Other Countries
ASEAN Countries having their own Registration formats :
Drug Registration in ASEAN : Dr.G.V.R.Joseph
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
ASEAN Countries having their own Registration formats :
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 AddressPhone Fax e-mail:
+ + +
9 Name of Manufacturer + + +
Premises Address Postal AddressPhone Faxe-mail
+ + +
Drug Registration in ASEAN : Dr.G.V.R.Joseph
10 Name of Local Agent +
11 Business AddressPhone Faxe-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
+ + +
Countries having separate Herbal Medicine Registration format Cont..
Drug Registration in ASEAN : Dr.G.V.R.Joseph
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 +
Countries having separate Herbal Medicine Registration format Cont..
Drug Registration in ASEAN : Dr.G.V.R.Joseph
Comparative Chart with respect to details of Plant Monographs in standard books
Drug Registration in ASEAN : Dr.G.V.R.Joseph
S. No.
Headings WHO AHP ESCOP PDR
EMEA community monograph
& Quality tests
BHC
BHP
SLM
IP API UP HP IHP ICMR
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
√ √ √ √ √ √
Comparative Chart with respect to details of plant Monographs in standard books Cont..
Drug Registration in ASEAN : Dr.G.V.R.Joseph
S. No. Headings WHO AHP ESCOP PDR EMEA community
monograph & Quality tests
BHC
BHP SLM IP API UP HP IHP ICMR
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 √ √ √ √
Comparative Chart with respect to details of plant Monographs in standard books Cont..
Drug Registration in ASEAN : Dr.G.V.R.Joseph
S. No.
Headings WHO AHP ESCOP PDR
EMEA community monograph
& Quality tests
BHC
BHP
SLM
IP API UP HP IHP ICMR
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
√
Comparative Chart with respect to details of Plant Monographs in standard books Cont..
Drug Registration in ASEAN : Dr.G.V.R.Joseph
S. No.
Headings WHO AHP ESCOP PDR
EMEA community monograph
& Quality tests
BHC
BHP
SLM
IP API UP HP IHP ICMR
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 √ √ √ √ √ √
Comparative Chart with respect to details of plant Monographs in standard books Cont..
Drug Registration in ASEAN : Dr.G.V.R.Joseph
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
Thank You
Drug Registration in ASEAN : Dr.G.V.R.Joseph