1 FDA Thailand By HIV Module/Marketing Group Mr. Manaswee Arayasiri.

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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

• 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

• 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

• 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

The subcom m ittee consider

Experts consider

Officers consider

Send protocol to asking for B ioequivalence study

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Procedure (Continue)

Approve

Approve Not approve

Reconsider

Correct/adjust Not approve

The subcom m ittee consider

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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

• 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 production/order sam ple drug

Officers consider

Producer asking for production/order sam ple drug

Approve for B ioequivalence study

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Procedure (Continue)

Asking for register pharm acopoeia

Result of B ioequivalence study

Producer can begin B ioequivalence study

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Drug registration procedure

• Step 3 : Asking permission for register pharmacopoeia

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Document for application

• 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

The subcom m ittee consider

Experts consider

O fficers consider

Asking for register pharm acopoeia

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Procedure (Continue)

Approve

Approve Not approve

Reconsider

Correct/adjust Not approve

The subcom m ittee consider

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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

• Dr. Suvit

• Dr. Maria

• Mrs. Podjana

• all listeners

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Thank you for pay attention