Transcript FDA of Thailand - Chulabhorn Research Institute

FDA Thailand
By
HIV Module/Marketing Group
Mr. Manaswee Arayasiri
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FDA Thailand
• Introduction
• Drugs registration
• The effect of FDA on Marketing
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Introduction
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About FDA Thailand
Role and Responsibility
Relating Acts
Administration of Acts
Organization of FDA for controlling
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About FDA Thailand
• Consumer protection activities on food
and drugs have begun in Thailand since
1909
• Established in 1922 as a Narcotic division
• In 1937, the agency renamed to Food and
Drug division
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About FDA Thailand
• In 1953, the agency renamed to Division
of Food and Drug Control.
• In 1974, Division of Food and Drug
Control was promoted to be the Office of
Food and Drug Administration, having
the status as department of Ministry of
Public Health.
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Roles and Responsibilities
• Major is to ensure that health
products(i.e. food, drug etc.) available to
consumers are of standard quality,
efficacy, and safety.
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Roles and Responsibilities
• Main tasks are to control and monitor
both pre- and post-marketing phases of
manufacture, import, transport, storage
and sale
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Relating Act
• Drug Act 1987 (5th revision)
• Food Act 1979
• Cosmetic Act 1992
• Narcotic Act 1987 (3rd revision)
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Relating Act
• Psychotropic Substances Act 1992(3rd
revision)
• Volatile Substances Act 1990
• Medical Devices Act 1988
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Administration of Acts
• Committees of drug, food, narcotics,
cosmetics etc. follow Acts
• Committees to develop policies and
promote technological development on
food, drugs and chemical safety
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Organization of FDA for
controlling
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Drug control division
Food control division
Toxic substance control division
Narcotic control division
Cosmetic control division
Medical device control division
Public relation and Advertisement control
division
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Drug Registration
• How to register drugs
• Drugs registration procedure
• Other registration
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How to register drug
• Contact Drug control division FDA
Thailand Ministry of Public Health
Nonthaburi Thailand
• E-mail address: www.fda.moph.go.th
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Drug registration procedure
• In this HIV module, Assume use
procedure of new drugs registration in
term of Generic drug
• Generic drug is an imitation of an
original brand-name drug, when the
patent or trademark protection on
original brand-name drug expires
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Drug registration procedure
• Step 1 : Asking permission for
Bioequivalence study
• Step 2 : Asking permission for
produce/order sample drug for study
• Step 3 : Asking permission for register
Pharmacopoeia
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Definition
• Pharmacopoeia is a book described
drugs; one issued by an officially
recognized authority and serving as
standard
• Bioequivalence study is study drugs in
term of therapeutic response compare
between innovator product and original
product
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Drug registration procedure
• Step 1 : Asking permission for
Bioequivalence study
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Document for application
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Label every size of container
Accompany literature
Clinical trial report
Certificate of free sale
Detail of protocol for Bioequivalence
study
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Procedure
Send protocol to asking for Bioequivalence study
Officers consider
Experts consider
The subcommittee consider
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Procedure (Continue)
The subcommittee consider
Approve
Correct/adjust
Not approve
Reconsider
Approve
Not approve
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Drug registration procedure
• Step 2 : Asking permission for
produce/order sample drug for study
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Document for application
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Label every size of container
Accompany literature
Certificate of GMP
Certificate of free sale
Certificate of Analysis
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Definition
• Certificate of GMP is certificate for
factory about Manufacturing practice
follow WHO practice
• Certificate of Free Sale is document
present that drug is legally sold in the
country of origin
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Definition
• Certificate of Analysis is report present
result of pharmaceutical product
standard checking
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Procedure
Approve for Bioequivalence study
Producer asking for production/order sample drug
Officers consider
Approve for production/order sample drug
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Procedure (Continue)
Producer can begin Bioequivalence study
Result of Bioequivalence study
Asking for register pharmacopoeia
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Drug registration procedure
• Step 3 : Asking permission for register
pharmacopoeia
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Document for application
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Sample drugs
Label every size of container
Accompany literature
Result of Bioequivalence study
Finished product Specification
Certificate of free sale
Certificate of import drug (Step 2)
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Procedure
Asking for register pharmacopoeia
Officers consider
Experts consider
The subcommittee consider
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Procedure (Continue)
The subcommittee consider
Approve
Correct/adjust
Not approve
Reconsider
Approve
Not approve
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Other registration
• License to produce drugs
• License to sell drugs
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The effect of FDA on
Marketing
• Cost of product
• Regulation in Selling
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Cost of Product
• Bioequivalence Study
• License for register, production, selling
drug
• Quality control in production and
environment
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Regulation in Selling
• Producer must have license for sell drug
• Amount of selling must follow license
• Advertisement ; clearly, include side
effect and no over/false the real
properties
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Thank you very much
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Dr. Suvit
Dr. Maria
Mrs. Podjana
all listeners
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Thank you for pay attention
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