Thailand: Drugs

Clinical Trial Data Requirements

There is no centralized regulation of clinical trials in Thailand. Thai FDA does not directly regulate human clinical trials, rather it regulates drug importation for research. After identifying a local facility to conduct a clinical trial, the sponsor must receive approval from the Ethical Review Committee for Research in Human Subjects (ERC) of the Ministry of Public Health and/or institutional ethics committees. Usually, approval from the ERC is optional. After ethics approval is granted, the sponsor can apply to import investigational products into Thailand for research. This requires the following:

-Description of drug to be imported.
-Pre-clinical trial reports.
-Clinical trial protocol.
-Estimate of drugs to be imported.
-Power of attorney. 

 The import license is valid for a year. If the clinical trial duration exceeds a year, the sponsor must obtain a new import license.

Clinical Trial Import Authorization

Following approval of the study protocol by ethics committees, the investigator can apply for an import license. The application form is "NorYorMor1" (NYM1) for medicines. The application form should be completed in Thai, with supporting documents in either Thai or English. Two A4 hard copies are required for the application. Applications should be submitted here:

Address for submission of all applications:
One Stop Service Center
Food and Drug Administration
Ministry of Public Health
88/24 Tiwanond Road,
Nonthaburi 11000
Thailand
Tel: Int. +66 2 5907439 (medicinal products)
Int. +66 2 5907420 (medical devices)

Address of International Affairs and Investigational New Drug Section:

International Affairs and Investigational New Drug Section
Drug Control Division
Food and Drug Administration
Ministry of Public Health
88/24 Tiwanond Road,
Nonthaburi 11000
Thailand
Tel: Int. +66 2 5907167 or Int. +66 2 5907061
Fax: Int. +66 2 590 7061

The entire process takes an estimated 4 weeks for medicines.

Clinical Trial Timelines

According to Division of AIDS Clinical Research Support Services, 4 weeks.

Clinical Trial Costs

Fees depend on the research institution and vary by ethics committee. Fees range from THB 5000 - THB 53,500.

Liability Policy

There are no national requirements for clinical trial insurance. Ethics committees require an informed consent statement that guarantees the availability of treatment for a study-related injury, and whether or not compensation will be offered.

In-Country Manufacturing Requirements

The Thai FDA issues licenses to manufacture in Thailand. The applicant must be the business owner, a Thailand resident, and have the facilities to produce, sell, import or store drugs and relevant equipment. To apply for a manufacturing license, the applicant must submit an application to the Drug Control Division of the Thai FDA. The Ministry of Public Health then inspects the applicant's facilities to assess compliance with Good Manufacturing Practices (GMP). Inspectors can also monitor manufacturing process changes. Any violation of the Drug Act can result in termination of the manufacturing license.

 A license to manufacture medicines costs THB 8,000 for modern medicines and THB 5,000 for traditional medicines, and are valid up until December 31 of the year that the license is issued. Applicants must apply to renew manufacturing licenses before they expire.

Precedent (Clinical Trials Approved/Denied in Last 2 Years)

309 clinical trials approved from June 2012 to June 2014.

Product Registration Data Requirements

Thailand uses the ASEAN Common Technical Dossier (ACTD) format, which is organized in four parts:

1. Table of Contents, Administrative Data and Product 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).

2. Quality Document.
Section A: Table of Contents.
Section B: Quality Overall Summary.
Section C: Body of Data.

3. Nonclinical Document.
Section A: Table of Contents.
Section B: Nonclinical overview.
Section C: Nonclinical written and tabulated summaries.
-Table of Contents.
-Pharmacology.
-Pharmacokinetics.
-Toxicology.
Section D: Nonclinical study reports.

4. Clinical Document.
Section A: Table of Contents.
Section B: Clinical Overview.
Section C: Clinical Summary.
-Summary of Biopharmaceutics and Associated Analytical Methods.
-Summary of Clinical Pharmacology Studies.
-Summary of Clinical Efficacy.
-Summary of Clinical Safety.
-Synopses of Individual Studies.
Section D: Tabular Listing of All Clinical Studies.
Section E: Clinical Study Reports.
Section F: List of Key Literature References.

Product Registration Estimated Timeline

According to a presentation by Siriporn Chawanon of the Drug Control Division: 210-280 working days; Priority review: 100-130 working days.

Product Registration Costs

THB 2000 is the Thai FDA fee for a new drug registration.

Post Registration Labeling Requirements

Section 25 of the Drug Act B.E. 2510 (1967) contain labelling requirements. The Act can be found here.

Post Registration Pharmacovigilance Requirements

Investigators are expected to submit serious, suspected, and unexpected safety reports to ethics committees when adverse events occur. Timelines for reporting varies based on ethics committees.

For serious unexpected adverse drug reactions only, investigators must submit serious adverse events to the Thai FDA Drug Control Division. Submission of safety reports from adverse events in other countries can be submitted annually in an Annual Safety Reports/Line Listing, but this is not mandatory. There is no preferred adverse events reporting format. Reporting should be hand delivery, no electronic reporting is accepted.

Once registration is obtained, the license owner needs to create and submit a protocol of Safety Monitoring Programme to the FDA. Products must follow this for at least two years.

Marketed products have samples that are tested regularly to monitor for compliance. Deficiencies can result in product recall. 

A detailed overview of Thailand's pharmacovigilance system is available here.

Last Updated

September 26, 2014.