Thailand Pharmaceutical Registration
Your TFDA Gateway
Regulatory . Certification . Licensing . Assurance
Navigate Thailand's attractive 188 billion Thai baht ($6.4 billion) pharmaceutical market with expert local representation. Our Thailand-based team provides comprehensive TFDA registration services and local representative solutions to overcome regulatory complexities and accelerate your market entry in one of ASEAN's larger economies.
Why Thailand
Strategic Market Position in ASEAN's Pharmaceutical Landscape
Major ASEAN Economic Hub
Thailand is one of the larger economies within ASEAN and has been an active participant in the regional economic and political landscape. Thailand's pharmaceutical market, valued at around 188 billion Thai baht or $6.4 billion, is a very attractive market for pharmaceutical companies.
Regulatory Framework Structure
The Thai FDA, under the Ministry of Public Health, regulates the market with comprehensive oversight ensuring:
• Safety and quality standards for all pharmaceutical products
• Rigorous evaluation and approval processes
• Post-market surveillance and compliance monitoring
• Alignment with international pharmaceutical standards
Our Thailand Services
Local Representative Requirements & Challenges
Foreign pharmaceutical companies looking to register their products in Thailand must appoint a local representative to facilitate communication with the TFDA and ensure compliance with all regulatory requirements.
Key Regulatory Challenges:
• Stringent documentation requirements for drug registration
• Preparation and submission of administrative documents
• Translation and dossier preparation in compliance with local requirements
• GMP clearance requirements and facility inspections
• Complex regulatory compliance and ongoing maintenance
Critical Success Factor:
Identifying a reliable and qualified local representative can be a crucial factor to the successful registration with TFDA.
Dynamic Regulatory Environment
Regulatory policies in Thailand are constantly being updated, impacting the drug registration process. Companies need to stay abreast of any policy changes and adapt their strategies accordingly.
Market Growth Drivers
Despite the regulatory complexities, the market is expected to grow due to several key factors:
Healthcare Expansion Factors:
• Increasing incidence of chronic non-communicable diseases
• Expansion of universal health coverage improving access
• Rise in the number of foreign patients seeking treatment in Thai hospitals
• Medical tourism growth driving demand for advanced pharmaceuticals
• Aging population increasing pharmaceutical consumption
Our Experiences
Over 10 years of experience in Regulatory Affairs.
Successfully registered over 5 New Drug Applications (NDAs) in Thailand within the past 5 years, encompassing diverse therapeutic areas such as small molecules, vaccines, and biologics. Beside new drug, we experienced in registering various product categories, including generic drug, animal drug, herbal drug, cosmetics, health supplements, medical devices, food supplements.
Provided comprehensive life-cycle management support, including variations and pharmacovigilance services.
Managed Thai FDA Good Manufacturing Practices (GMP) Clearance applications for foreign manufacturing sites.
Provided in-depth regulatory intelligence reports that significantly contributed to the successful market entry.
Facilitated submission consultations with the Thai FDA, resulting in successful resolution of regulatory queries and expedited product approval timelines.
Ready to Enter Thailand's 188 Billion Baht Pharmaceutical Market?
Let's Navigate Your TFDA Registration Success
Don't let Thailand's regulatory complexities delay your market entry. Our Thailand-based regulatory experts, serving as your qualified local representative with deep TFDA knowledge, are ready to accelerate your pharmaceutical registration in this attractive $6.4 billion market with significant growth potential.
Contact us today to discuss how our Thailand expertise can unlock opportunities in one of ASEAN's largest pharmaceutical markets.
Our Establishment
Drug Facility Licensing
Drug facility licenses encompass sales establishments, manufacturing facilities, and import facilities. Thai drug regulations outline eligibility criteria for applicants, including legal entity status (natural or juristic person) and, for foreign applicants, the necessary business licenses or certificates as per the Alien Business Operations Act.
Pharmacist presence is mandatory at all licensed facilities. Licensees are obligated to adhere to relevant Good Practices (e.g., GMDP, GDP, GPP) and comply with all regulatory requirements. Overseas manufacturing facilities must obtain GMP Clearance. Currently, our import facility holds an establishment license in Thailand. We are diligently working to ensure full compliance with all Thai FDA regulations.
Overview of Pharmaceutical Product Registration in Thailand
Thai Food and Drug Administration, Ministry of public health, is the authority responsible for evaluating and approving pharmaceutical products. The process involves multiple steps to ensure that products meet stringent safety, quality, and efficacy standards.
Drug Definition
Drug under the Drug Act, B.E. 2510 (1967) and Amendment No.2 (1975), No.3 (1979), No.4 (1985) No.5 (1987) and No.6 (2019), means:
01
Substances recognized by pharmacopoeias notified by the Minister of Public Health
03
Substances which are pharmaceutical chemicals or semi-processed pharmaceutical chemicals or;
02
Substances intended for use in the diagnosis, treatment, relief, cure or prevention of human or animal diseases or illnesses
04
Substances intended to affect the health, structure or function of human or animal body
Regulation of Medicinal Products
01
Drug Act, B.E.2510 (1967) and its amendments
02
Ministerial notification on drug registration
Medicinal Product Classification in Thailand
Medicinal products are classified into the following categories:
Biologic Products
New Drugs and New Biological Drugs
Biosimilar
Classified by registration type:
New Generic Drugs
Generic Drugs
Veterinary Drug
Classified by channel of distribution:
Household Remedies Drugs
Dangerous Drugs
Special Control Drugs
Pre-packed Drugs
Registration Requirements for Pharmaceutical Products in Thailand
Medical product registration requirements in Thailand
Local Requirements
Thai FDA guideline and/or public manual
International Requirements
CTD
Registration Process
01
• Document Preparation: Prepare all required documents for drug registration according to the ICH eCTD standard.
• Drug Item List Creation: Create a drug item list for the registration application on the SKYNET system (https://privus.fda.moph.go.th/).
Applicant Preparation
02
Application Submission
• Electronic Application & Document Upload: Create a drug registration application on the SKYNET system and upload the required documents electronically, adhering to the ICH eCTD standard. You can upload documents via Docubridge or THAIRIMS, along with the completed drug registration application form (Form Yor.1).
• Application Fee Payment: Submit the application and pay the application fee to obtain an application number.
03
• Application Screening: The application will undergo screening. If documents are incomplete, you will have one chance to make corrections within 30 calendar days. Exceeding the due date or submitting incomplete revisions will result in application rejection.
• Evaluation Fee Payment: Upon passing the screening, the system will generate an application fee invoice. Applicants must pay the evaluation fee within 30 calendar days to avoid application rejection.
Screening Stage
04
Evaluation Stages
• Applicants have 30 calendar days to respond during the first evaluation stage, with a possible extension to 60 days.
• The same timeframe applies to the second evaluation stage (30 days with a 60-day extension option).
• If the evaluation exceeds two rounds, you will be required to agree to an extension as specified in the Thai FDA public manual.
05
• Committee Review and Decision: The responsible Health Authority (HA) will present the evaluation results to a committee for finalization.
06
• Product License Issuance: The final step is the issuance of the product license.
Registration Process Flow Chart
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Authority Registration Timeline for Pharmaceutical Products in Thailand
No | Submission Classification | - | Timeline (Working Day) | - |
|---|---|---|---|---|
Full Assessment | Abridged Assessment | CRP Reliance Assessment | ||
1 | New drug and New biological drug | 220 | 154 | 90 |
2 | Biosimilar | 230 | 154 | 90 |
3 | Human vaccine | 280 | 154 | 90 |
4 | Biological drug | 160 | 110 | 90 |
5 | Generic drug | 135 | 115 | 90 |
*Subject to change, always refer to the official website for the latest information
Authority Registration Fees for Pharmaceutical Products in Thailand
No | Submission Classification | - | Fee (Thai Baht) | - |
|---|---|---|---|---|
Submission Fee | Evaluation Fee | License Fee | ||
1 | New drug and New biological drug | 2,500 | 2,000 | |
• NCE | 182,500 | |||
• Non-NCE | 155,000 | |||
2 | Biosimilar | 1,000 | 196,500 | 2,000 |
3 | Human vaccine | 1,000 | 182500 | 2,000 |
4 | Biological drug | 1,000 | 123,000 | 2,000 |
5 | Generic drug | 1,000 | 2,000 | |
• Compendial | 59,000 | |||
• Non-compendial | 39,000 |
*Subject to change, always refer to the official website for the latest information
How can we help?
• Pre-Market Strategic Consulting and Feasibility Assessment
• Regulatory intelligence and market entry strategy
• Product classification and regulatory gap analysis
• GMP compliance auditing and advisory
• Dossier preparation and submission handling
• Local Entity Support
•Life Cycle Management such as post-market surveillance and pharmacovigilance support
• Manage consultation activity with Health Agency
• Import License Application
• Change of Product Registration Holder
• Ad-hoc Regulatory Affairs Consultation
