Manaswee Arayasiri

FDA Thailand

1. Introduction
Acquired Immune Deficiency Syndromes (AIDS) is an important disease in this century.
Many scientists are searching for a way to cure this disease, but until today a
treatment for AIDS has not been discovered. Drug Companies continue to look for
a drug that can be used to cure this disease already thinking about how their drug
could be marketed. Because of the increasing number of AIDS patients every year
and the high a number of patients, AIDS-curing drug is in high demand from
patients that want to cure their disease. If a Drug Company discovers a new drug
that is more efficient than the drugs that sell in the market, the Drug Company can
make a significant profit from AIDS patient. If they have a good marketing group
to find such market, and to collect information about how to sell drug in any
country etc, they will use this information to make decision about selling the drug.
Accordingly, AIDS is an important disease and the drug that are used to cure this
disease are important too. So, if our Drug Company wants to make profit from
selling AIDS-curing drug, the marketing will play an important role. Information
about how to sell drug in any country that is a marketplace is important. If Drug
Company knows that this country is a big market, but the drug from Drug
Company is not registered from government of this country to use. The Drug
Company will not be able to sell the drug and it will loose profit from selling drug
in this country. The government office that has responsibility to approve a drug for
use in Thailand is The Office of Food and Drug Administration of Thailand (FDA
Thailand). Thus, FDA Thailand plays an important role for a Drug Company that
wants to sell a drug in Thailand. In this report, I will describe the procedures that
need to be followed in order for our Drug Company to get approval by the FDA
Thailand to sell our drug in Thailand.

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2. FDA Thailand and marketing

2.1 Introduction about FDA Thailand
2.1.1 A brief history of FDA Thailand
Consumer protection activities on food and drugs were begun in Thailand in 1909. Earlier
activities emphasized merely on controlling of adulteration in food and drugs. The scope
of responsibilities has been expanding since then. Historical evolution of the office can be
chronologically listed as follows:
 1922: Narcotic Act was the first promulgated registration. The agency was therefore
named as the Narcotic Division, which was operating under Ministry of Interior.
 1937: The agency was restructured and renamed as Food and Drug Division under
Ministry of Interior.
 1953: The agency was expanded and moved from Ministry of Interior to Ministry of
Public Health and renamed as Division of Food and Drug Control.
 1974: The Division of Food and Drug Control was promoted to be the Office of Food
and Drug Administration, having the status equivalent to a department of Ministry of
Public Health.
2.1.2 Roles and Responsibilities of FDA Thailand
Major roles and responsibilities of FDA Thailand are to ensure that health product (food,
drugs, cosmetics, medical devices, narcotic substance, and household hazardous
substances) available to consumers are of standard quality, efficacy, and safety. The main
tasks of the office are to control and monitor both pre- and post-marketing phases of
manufacture, import, transport, storage and sale up to the requirements of eight Acts. The
eight Acts consist of Food Act 1979, Drug Act 1987#(5th revision), Cosmetic Act 1992,
Narcotic Act 1987#(3rd revision), Psychotropic Substance Act 1992#(3rd revision),
Volatile Substances Act 1990, and Medical Devices Act 1988. Administration of the Acts
is performed through eight committees that follow any of Acts and three committees that
develop policies and promote technological development on food, drugs and chemical
safety.
2.1.3 Organization of FDA Thailand
At present, the office of Food and Drug Administration comprises of ten divisions and
two small entities. The divisions related to controlling product, are the following:
 Food control division has a duty to follow Food Act and control quality standard,
control food production plant, give certificate of food register, give license to produce
and import food, and research and development food product.
 Drug control division has a duty to follow Drug Act and control quality standard, give
certificate of drug register, give license to produce, import and sell drug, and research
and development drug product.
 Cosmetic control division has a duty to follow Cosmetic Act and control quality
standard, give certificate of cosmetics register, give license to produce, import and
sell cosmetics, and research and development cosmetic product.
 Medical devices control division has a duty to follow Medical devices Act and ensure
that development, support, control and monitor medical devices which are produced,
imported or sold have quality standard and are efficient and safe to use.

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 Toxic substance control division has a duty to follow Toxic substance Act in section
of household toxic substance and set standard, conclude and distribute information
about danger of toxic substance in any products, give license to produce toxic
substance.
 Narcotic control division has a duty to follow Narcotic Act and Psychotropic
Substance Act and set quality standard, control production plant, give certificate of
narcotic register, and give license to produce and import narcotic substance.
2.2 How to sell new drug in Thailand?
The Drug Company can get information about the FDA Thailand approval process for
selling a drug by going to the FDA Thailand homepage www.fda.moph.go.th or by
contacting directly the Drug Control division of FDA Thailand Ministry of Public Health
Nonthaburi Thailand. Briefly, the process of drug approval by the FDA Thailand starts
from asking for permission to import drugs for approval or study. After completion of the
study, the company can send the results of the study and other documents to register the
drug and ask permission to produce and sell the drug later.
2.2.1 General information
“Drug” in the meaning of Drug Act, is any substance that is intended for use in the
diagnosis, treatment, relief, care or prevention of human or animal disease or illness. The
drugs have many types such as antibiotics, vaccines etc. FDA regulates drug registration
of all types of drugs. Other information from Drug Act includes:
 With respect to registration, FDA Thailand separates new drugs in two categories:
original drug registration and generic drug registration.
 The companies who want to have a license to produce, sell, and import drugs must
have a representative such as a manager to conduct its affairs. The representative
should nor less than 20 full years of age, and he/she should be resident of Thailand.
The representative should have never been judged guilty of an offence for which an
element provided by law is dishonesty or an offence under the law on sale of drugs or
this Act for which the penalty provided includes imprisonment. The representative
must not be mentally sick or declared incompetent or quasi-incompetent and must not
be afflicted with leprosy, tuberculosis in the dangerous stage, elephantiasis in the
stage where the symptoms appear to be socially objectionable, severe drug addiction
or chronic alcoholism.
 The company must have premises to produce sale or store the drugs and be able to
control and maintain the quality of drugs with respect to character and quantity. The
company must use a trade name, which is not a repetition of, or similar to the trade
name used by a licensee whose license is suspended or has been revoked for less than
a full year. The company must have persons to follow the Drug Act such as first class
pharmacists, second class pharmacists etc. After the company has satisfied the a fore
mentioned requirement, it can ask for license to produce or import new drug for study
and ask to register the drug later.
2.2.2 Process of asking for license to import drugs for study
The company must first prepare the documents for asking for a license to import drugs.
Those include:
 Label every size of container and label present protocol code No.
 Accompany literature
 Clinical trials report from origin country of drugs

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 Certificate of free sale from origin country of drugs

 Detail of protocol for study include amount of drug that will be used in the study such
as protocol for bioequivalence study (generic drugs), protocol for clinical trials study
(original drugs) etc. that has been approved by doctors and other researchers of this
study.
The company will then send the document to Drug Control Division and will ask for
license to import drugs for study as shown in Figure 1. After the company has received
license to import drugs for study, it can begin the bioequivalence study or the clinical trial
study later. If the drug is registered, this license can also be used to import the drug for
sale. The fee for the license to import drugs is 10,000 bahts (~$250) per year. The license
to import drugs has duration of 1 year, so the Drug Company must renew the license
before its expiration every year.

Send documents to ask for license to import drug

(1 day)

Officers consider documents, plan and picture of storage place

(10 days)

Approve Correct and Adjust Not approve

(4 days) Reconsider

Applicant receives Send result to applicant

license to import drugs

Figure 1 Process of asking for license to import drugs in Thailand

2.2.3 Process for register new drug

FDA Thailand separates process for registering a new drug in two types: process for
registering generic product (Figure 3) and process for registering original product (Figure
4). The company must first prepare the documents for asking to register new drugs
(original and generic drugs). Those include:
 Sample drugs of all color and types
 Label every size of container
 Accompany literature (in Thai and English language)

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 Copy of Finished Product Specification

 Copy of license to import drugs
 Certificate of free sale from origin country of drugs
 List of countries that register this drug including Status/Category of drugs and
provision of selling drugs in each country
 Patent of this drug which include country that give patent, beginning date of patent,
and patent expired date.
 Result of bioequivalence study # (for generic drugs only)
 Chemical and Pharmaceutical documentation
 Toxicological documentation
 Pharmacological documentation in animal studies
 Clinical documentation
 Pros and cons between a new drug and other drugs that are currently used for the
treatment of the same disease in Thailand.
The process of registering new generic drugs is shown in Figure 2, First, Drug Control
Division considers the protocol for the bioequivalence study. Second, after the drugs have
been approved for the bioequivalence study, the Drug Company can begin the
bioequivalence study. Finally, the Drug Company sends the results of the bioequivalence
study and other documents for registering drugs.
The process of registering original drug is shown in Figure 3. First, the Drug Company
sends the documents to Drug Control Division for consideration. Second, after drug is
registered under provision, this drug can only be used at hospital under the control of
doctors. The Drug Company must follow a SMP (Safety Monitoring Program) protocol,
collect data about unsatisfactory symptoms for a minimum of 2 years and report follow
timetable that Drug Control Division approve. Finally, Drug Company sends result of
safety evaluation to subcommittee for consideration later. After new generic and original
drugs are registered, Drug Company can ask for license to produce and sell drug in
Thailand.
Remark
 If the Drug Company wants to do clinical trials in Thailand before sending the results
for registering original new drugs, the Drug Company will do the following. First, the
Drug Company will contact the hospital that will be used in the study, and the doctors
that will set and control this study. After that, the Drug Company will send a detailed
clinical trials protocol that has been approved by the doctors and other researchers
who have studied this protocol and ask for license to import drugs for study.
 A Foreign company that has never applied for drug registration in Thailand before or
a company that never had a drug that is registered in other countries before, must send
additional documents for drug registration including Certificate of GMP (Good
Manufacturing Plant), Accreditation Oversea Supplier, Drug Price List, and
Certificate of Analysis.
 The fee of registering a new drug which is 2000 bahts (~$50)
 At present time, anti-HIV drugs that are registered in Thai pharmacopoeia are:
Crixivan, Fortovase, Stocrin, Viracept, Viramune, and Ziagenavir.
 A Comparison between the FDA Thailand (Figure 3) and the FDA US (Figure 4) for
original new drug registration is shown in Table 1

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Send protocol to ask for the Bioequivalence study

(3 days)

Officers, Experts, and Subcommittee consider

(20 days)

Approve Correct and Reconsider Not approve

Send result to applicant

(5 days)

Drug Company can begin

Bioequivalence study

(Time depends on Drug Company)

Send result of Bioequivalence study

and other documents to register drug

(4 days)

Officers, Experts, and Subcommittee consider

(40 days)

Approve Correct and Reconsider Not approve

(20-35 days) Drug committee considers

Drug is registered Send result to applicant

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Figure 2 Process for registering a new generic drug in Thailand

Send documents for registering original drugs

(10 days)

Officers, Experts and subcommittee consider

(40 days)

Approve under Correct and Reconsider Not approve

Provision

Send SMP protocol Drug committee considers

(30 days)

Drug is registered under provision Send result to applicant

(Drug can only be used in hospitals under the control of doctors)

(2 years or over)

Send result of safety evaluation from using drugs

to subcommittee for consideration

Approve Not approve

Drug is traditionally registered (can be sold in market)

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Figure 3 Process for original drugs registration in Thailand

Pre-clinical study

(2 years)

Send result of Pre-clinical trials to IND =Investigative

ask for IND by FDA consider Drug
Application

(30 days)

Approve Not approve

Clinical trials study

(7 years)

Send result of Clinical trials study

and ask for NDA by FDA NDA = New Drug Application

(45 days)

Fileable Not fileable

(3-4 months to 2 years)

Approve Not approve

Marketable product

Sales Post-marketing surveillance

Figure 4 Process for original drugs registration in US.

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Parameter FDA Thailand FDA US.

Pre-clinical They are only concerned with Control this process by considering
trials results Pre-clinical trials results before
approving IND
Clinical Control this process by Control this process by considering
trials considering Clinical trials results Clinical trials results before beginning
before beginning drug registration drug registration process
process
Time for 80 days 45 days
drug
registration
under
provision
Time for 2 years or over 3.5 months-2 years
post-
surveillance

Table 1 Comparison between the FDA Thailand and the FDA US for new original drug
registration.

2.2.4 Process of asking for license to produce drugs

If a Drug Company has a production plant that is registered in Thailand. it can ask for
license to produce drugs. The company must first prepare the documents asking for
license to produce drugs. Those include:
 Picture, and Copy of Family registration of applicant
 Document showing ownership of the drug factory and property
 A contract between the applicant and the first class pharmacist under which the latter
has the duty to work for the applicant.
 A certificate of the first class pharmacist’s license and of every pharmacists who shall
work for the applicant.
After sending the documents a fore mentioned to Drug Control Division, the process for
consideration follows Figure 5. After the Drug Company has received a license to
produce drugs, the company can begin to produce drugs for sale. The fee for the license
to produce drugs is 8,000 bahts (~$200) per year. The license to produce drug has
duration of 1 year, so the Drug Company must renew license before its expiration every
year.
2.2.5 Process of asking for license to sell drug
A Drug Company that holds a license to produce or import drugs, must follow drug Act
1987#(5th revision), which stipulates that the Drug Company is also holder licensed to
wholesale modern drugs in respect of drugs which they produce or import as the case
may be. This means that the Drug Company automatically received license to wholesale
modern drugs after receiving the license to produce or import drugs for sale. Wholesale
means sale direct to the licensee to sell drug, licensee for wholesale of drug, Ministry,
Bureau, Department, Thai Red Cross Society, Pharmaceutical Organization, Licensee to

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operate place of treatment, Practitioner of pharmaceutical profession, Practitioner of

nursing profession, Practitioner of pediatrics, Practitioner of nursing and pediatrics, and
Practitioner of modern art of healing. Licensee means persons who are licensed under
Drug Act to sell drugs. The fee for license to wholesale modern drug is 2,000 bahts
(~$50) per year. This means that the license to wholesale drug has duration 1 year, so the
Drug Company must renew license before its expiration every year.

Send documents to ask for license to produce drug

(1 day)

Officers consider

(7 days)

Approve Correct and Adjust Not approve

Reconsider

Tell applicant to prepare plant Send result to applicant

for officers investigation
(20 days)

Officers investigate plant

Subcommittee considers

(12 days) Correct and Adjust

Approve

Applicant is received
License to produce drug

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Figure 5 Process of asking for license to produce drug in Thailand

3. Conclusion
To summarize the necessary processing for a Drug Company that wants to sell new drugs
in Thailand is the following. First, contact with hospital and doctors and prepare a
protocol for drug study such as a protocol for bioequivalence study (generic drug) or a
protocol for clinical trials (original drug). Second, send protocol to Drug Control Division
for consideration. After Drug Control Division has approved the protocol, the Drug
Company can ask for license to import drugs for study, and after receiving this license,
the Drug Company can begin the study following the protocol. After the study is finished,
the Drug Company will send the results of the study to FDA Thailand. Finally, after the
drug is approved for use in Thailand, the Drug Company can ask for license to produce
drugs for sale or use license to import drugs that was received before to order drug from
abroad for selling. If Drug Company has a license to produce or import drugs, they will
automatically receive license to wholesale drug. After completing of this process, the
Drug Company can sell new drug in Thailand. As can be seen from the above, FDA
Thailand is very important for a Drug Company that wants to sell drug in Thailand. If the
drug of the Drug Company is not registered by FDA Thailand or if the drug is registered,
but the company does not have license to produce or sell drugs from FDA Thailand, the
Drug Company can not make any profit from selling drug in Thailand. In addition to the
summary of the process, if our Drug Company want to sell Crixivan in Thailand, it will
do the following. At present time, Crixivan is registered in Thai pharmacopoeia. First,
our Drug Company must check whether Crixivan is patented in Thailand. Second, if the
patent of Crixivan in Thailand has expired, our Drug Company can sell this drug in
Thailand by asking for license to produce or import this drugs. After our Drug Company
receive a license to produce or import Crixivan, they will automatically receive a license
to wholesale Crixivan. Finally, after the completion of this process, our Drug Company
can sell Crixivan in Thailand.

Source of information and Acknowledgement

 Drug Control Division, The Food and Drug Administration of Thailand, Ministry of
Public Health Thailand.
 FDA library, The Food and Drug Administration of Thailand, Ministry of Public
Health Thailand.
 Drug Act (1st-5th revision)
 Ministerial Regulation (No. 1-5, 7-13, 21-22) issued under the Drug Act 1967

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