Thailand

 

 

 

 

 

 

Introduction

The Kingdom of Thailand (Formerly Siam) has an estimated population of 65 million with a GDP per capita of around US $9,084 (See Thailand for additional information). Thailand’s government is a constitutional monarchy with His Majesty King Bhumibol Adulyadej sitting at the head of state with the prime minister and a 250-member unicameral national assembly appointed by the Council of National Security. Thailand has enjoyed economic prosperity and rapid development since the 1980′s and is currently considered a recently developed nation.

NOTE: Referencing the “country specific” links to the right of this page will provide additional information relative to the country of interest. Also, by clicking the yellow Clinical Research Compliance and Clinical Laboratory Compliance bars above, will allow one to easily traverse this website to find country specific information relating to both topics.

Regulatory History

The regulation of pharmaceutical products in Thailand began in 1909 with basic laws prohibiting the adulteration of drug products and narcotic substances. Currently, the Drug Act of B.E. 2546 (1967) as amended in 1987 is in effect (The updated New Drug act of 2003 is in the final stages of development but has not yet been implemented).

The Medical Device Act of B.E. 2531 (1988) was the first legislation to specifically address issues related to medical devices (Prior to enactment of this legislation medical device issues were referred to provisions of the Drug Act). Medical devices are categorized by potential patient risk and parallel the European Union and United States systems (i.e., Thai catagories II and III versus classes II and III). Additionally, the requirements for General Good Manufacturing Practice (GMP) standards for drugs and medical devices have been in place since 1984.

Thai FDA has also established its stance on future trends related to medical product regulations and is aligning itself internationally through APEC’s Life Science Innovation Forum (LSIF) and regionally with ASEAN’s Harmonization on Healthcare Products which includes both drug and medical device product working groups.

Clinical Trial Conduct in Thailand

The advantages of conducting clinical research in Thailand are similar to those of other countries within the region which include: ease of subject recruitment, fewer competing clinical trials than in the west; highly educated and trained personnel pool; potential to generate sound clinical data and access to low cost infrastructure and labor pools.

Clinical trials in Thailand are conducted under the auspices of the Thai Ministry of Public health (TMOPH) and the Thai Food and Drug Administration (TFDA). Thai regulatory standards are well established and Thai requirements are similar to those of other regional governments (e.g. South Korea, Singapore and Taiwan) in detail and application. Thailand’s National Policy on Clinical Studies states that “Thailand is dedicated to supporting and promoting the conduct of clinical studies in compliance with the Good Clinical Practice Standard so as to ultimately advocate Thailand to be a world-class center of excellence in clinical trials.” To achieve this goal Thailand requires all clinical investigators and sponsors to conduct clinical research under ICH – GCP E6.

In order for a clinical trial to be conducted in Thailand, it must be approved by the clinical trial site’s Independent Ethics Committee (IEC) and the Thai FDA. Clinical trial approval by Thai FDA and specific IEC cannot be run in parallel. To conduct a clinical trial at a single investigational site or institution, a protocol approval by the institutions IEC must be secured. If multi-institutional sites are to be utilized by the clinical trial sponsor, then the protocol must be approved by the Thai MOPH IEC and any site specific IECs that require protocol approval as per each entities IEC requirements.

Once the sponsor’s protocol is approved by the appropriate IEC(s), the sponsor must then submit the IEC approval letter to the Thai FDA to secure an Import Permit for the drug, biologic or medical device being considered. Thai FDA states that the Import Permit approval process will take no more than 4 weeks; however, since IEC approval must be secured prior to Thai FDA submission, this could delay the approval process for the clinical trial significantly. On average, approval for clinical trials should take from 12 to 16 weeks.

Please refer to the links below to secure applicable forms and supporting information from Thai FDA, Thai MOPH and other regional and international organizations.

Helpful Links and Information

Thai FDA One Stop Service Center Drug/Biologics Forms (Forms only available in Thai Language)

Thai FDA One Stop Service Center Medical Devices Forms (Forms Available in English)

คำขออนุญาตนำหรือสั่งยาแผนปัจจุบัน เข้ามาในราชอาณาจักร (Thai FDA Drug/Biologic Import Approval Form)

Thai FDA One Stop Service Center and Contact Information (English)

Thai FDA One Stop Service Center and Contact Information (English)

Contacts:

Thai FDA General Information –

Drugs/Biologics +662.590.7439

Medical Devices +662.590.7245 / FAX +662.591.8479

Thai FDA Document Control Division –

Drug/Biologics +662.590.7167

Medical Devices +662.590.7416

Regulatory and Infrastructure development Related Links:

Thai Ministry of Public Health Home Page

Thai Ministry of Public Health Organizational Chart

Thai FDA Home Page

Thai FDA Drugs

Thai FDA Medical Devices

Thai FDA Organizational Chart

APEC Life Sciences Innovation Information

APEC Home Page

Association of Southeast Asian Nations (ASEAN) Home Page

ASEAN Medical Device Working Group (MDWG) – General Information

ASEAN Pharmaceutical Product Working Group (PPWG) – General Information

Additional information related to PPWG

Asian Harmonization Working Party Contacts by Country – Medical Devices

 

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