Drug Registration in ASEAN Countries

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(No Transcript)
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ASEAN Association of South East Asian Nations
Brunei Cambodia Indonesia Lao Peoples
Democratic Republic Malaysia Myanmar Philippines
Singapore Thailand Vietnam
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• 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.

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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
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Major Exports

• Guar gum
• Menthol
• Chyawanprash
• Herbal extracts etc.

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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.

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

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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.

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• 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.

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• Lao Peoples Democratic Republic
• National policy on TM/CAM was included in the
  National Drug Policy issued in 1998. Regulations
  on herbal medicine in the Lao Peoples Democratic
  Republic were issued in 2002 Herbal medicines
  are regulated as over-the-counter medicines. In
  the Lao Peoples 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.

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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.

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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

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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.

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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.

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• 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.

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• 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.

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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

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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

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ASEAN Countries having their own Registration
formats
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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 War
ning 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
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ASEAN Countries having their own Registration
formats

• Lao Peoples 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

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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
• ExcipientSubstance 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

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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

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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 Rest
ricted/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
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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
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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

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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
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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
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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
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Comparative Chart with respect to details of
Plant Monographs in standard books
S. No. Headings WHO AHP ESCOP PDR EMEA community monograph Quality tests BHC BHP SLM IP API UP HP IHP ICMR
01 Definition v v v v v v v v v v v v
02 Nomenclature v v v v v v v v v
a. Botanical Nomenclature v v v v v v v v v
b. Botanical Family v v v v v v v v v
03 Synonyms v v v v v v v v v v
04 Selected vernacular names/ Common Name v v v v v v v
05 Description v v v v v v v v
06 History v v v
07 Plant Material of interest v v
i. General Appearance v v v v
Botanical Identification v v v
ii Organoleptic properties v v v v
Macroscopic Identification v v v v v v v v v
iii Microscopic characteristics v v v v v v v v v v v
iv Powdered plant material v v v v v v
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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 BHC BHP SLM IP API UP HP IHP ICMR
08 Commercial Sources Handling v
i Collection v v
ii Cultivation v v
iii Drying v
iv Handling v v
v Storage v v v
vi Adulterants v v
vii Preparations v v
09 Geographical distribution v v v v v v
10 General identity tests v v v v v
11 Purity tests v v v v
i. Microbiology v v v v
ii. Total Ash v v v v v v
iii Acid-insoluble ash v v v v v v v
iv. Water-soluble extractive v v v v v v
v. Alcohol-soluble extractive v v v v v v
vi Foreign Organic Matter v v v v v v
vii Loss on Drying v v v
viii. Pesticide residues v v
ix Heavy Metals v v v v
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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 BHC BHP SLM IP API UP HP IHP ICMR
x Radioactive residues v v
xi Other purity tests v
12 Chemical assays v v v v v v v v
13 Major Chemical constituents/ Constituents v v v v v v v v v v
14 Dosage forms v v v v v v v v v v v
15 Adulterants and Substitutes v v
16 Therapeutics v v v v v v v v
a. Pharmacokinetics v v v
b. Pharmacodynamics v v v
c. Preclinical Safety Data v
17 Medicinal uses v v v v v v
i. Uses supported by clinical data v v v v
ii. Uses described in pharmacopoeias and in traditional systems of medicine v v v v
iii Uses described in folk medicine, not supported by experimental or clinical data v
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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 BHC BHP SLM IP API UP HP IHP ICMR
18 Pharmacology v v v v v v v v
a. Experimental pharmacology v v
b. Clinical pharmacology v v v v
19 Contraindications v v v v v
20 Warnings v v
21 Pregnancy and lactation v v v
22 Effects on ability to drive and use machines v v
23 Overdose v v v
24. Precautions v v v v v v v
a. Carcinogenesis, mutagenesis, impairment of fertility v v
b. Other precautions v
c. Adverse reactions v v v v v
d. Interactions v v
e. Posology v v
f. Toxicology v v
25 Regulatory Status v v
26 References v v v v v v
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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
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Thank You
Drug Registration in ASEAN Dr.G.V.R.Joseph