Regulatory Affairs Services in Thailand

Strategic regulatory affairs solutions in Thailand for product approvals across pharmaceuticals, MedTech, nutrition, cosmetics, biologics, and veterinary industries. Partner with a trusted regulatory affairs consultant in Thailand to manage local requirements and support on-time market entry.

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Artixio's Regulatory Affairs Consultaion Services In Thailand

Thailand’s healthcare sector is significantly expanding, making it one of Southeast Asia’s most promising markets for pharmaceuticals, medical technology, nutritionals, and wellness products. According to a research forecast, healthcare spending in Thailand is expected to surpass $47.9 billion by 2026, driven by increasing healthcare access, demographic shifts, and government investment.

While the commercial opportunities are substantial, entering the Thai market requires precise regulatory planning. The Thai Food and Drug Administration (TFDA), under the Ministry of Public Health (MoPH), enforces strict requirements across all product categories. Local representation is mandatory for all foreign applicants, along with Thai-language documentation. Artixio’s Regulatory affairs consulting services can support accurate documentation, local coordination, and timely product registration.

Regulatory Documents Required in Thailand

The documents required for each module of the registration process varies with the product category. All documents must be provided in Thai or accompanied by certified Thai translations. A typical registration dossier includes the following:

Application form
Product composition or formula
Product label and packaging
Certificate of Pharmaceutical Product (CPP)
Good Manufacturing Practice (GMP) certificate or ISO 13485 (for medical devices)
Manufacturing license or company registration documents
Product information leaflet / Instructions for Use (IFU) in Thai
Test reports or studies (e.g., bioequivalence, clinical evaluation, stability, safety, risk assessments based on product type and risk class)
Import license or Thai business license of the MAH or distributor (as applicable)
Supporting technical documents (e.g., CTD modules, CSDT, ingredient safety data sheets, analytical method validation)

Regulatory Affairs Process In Thailand

Pre-Submission Process

Dossier Preparation & Localisation

Follow the standard format compliance: CTD for pharma/biologics, CSDT for devices, simplified formats for supplements.
Full translation into Thai is mandatory for all modules, product labels, inserts, and instructions.
GMP, CPP, and Power of Attorney documents must be legalized as per Thai FDA requirements.

Application Submission

Reviews and Clarifications

Product Approval & Post-Marketing Process

Product Approvals Timelines

Timelines may extend if translation, classification, or local representation requirements are not met at the time of submission.

Products	Timelines
New Pharmaceuticals	~280 working days
Generics	~155 working days
Medical Devices (Class 1)	~1-8 days for general medical devices ~200 working days for sterile or measuring devices
Medical Devices (Class 2 and 3)	~250 working days
Medical Devices (Class 4)	~300 working days
Cosmetics	~15-25 days ~60-90 days for controlled or high risk cosmetics
Biologics	150-250 working days
Veterinary Products	120 working days for generic modern chemical drugs 220 working days for new modern chemical drugs

Why Artixio As Your Regulatory Affairs Consultant In Thailand?

If you are launching your product in Thailand and looking for reliable regulatory support, Artixio provides strategic product registration services tailored to local requirements. We offer local insight, regulatory precision, and full-cycle support to help your products reach the market on time and in compliance with TFDA regulations. Connect with our Thailand regulatory affairs consultant today to move forward with confidence.

FAQs

1. Is Thai MAH mandatory for all product categories?

Yes, a local Thai entity is required to submit and maintain product registrations across all regulated product categories. Foreign companies must appoint a licensed MAH before initiating any regulatory activities in Thailand.

2. Can previously approved ASEAN CTD dossiers be reused?

Yes, ASEAN CTD dossiers can serve as a foundation for Thailand submissions; however, adaptations are mandatory. These include:

Translation of all modules (including Module 1 and labeling content) into Thai
Adjustments to comply with TFDA’s format and submission sequence
Potential updates to quality or clinical documentation based on TFDA’s latest circulars
In many cases, prior ASEAN approvals can streamline the process, but TFDA still requires full technical evaluation and local compliance validation.

3. Can I transfer my product registration to a new Thai license holder?

Yes, but only for drug products. According to the Thai FDA’s 2023 update, product licenses for drugs can be officially transferred to a new Thai license holder (MAH) through a formal process. This is useful when a foreign company changes its Thai distributor or consolidates its licenses.
The process includes:

Mutual agreement between the current and new MAHs
Submission of a transfer application to TFDA with all required documents
Reissuance of the license under the new Thai entity

Note: This transfer process does not apply to medical devices, cosmetics, or health supplements. For those product categories, a registration/ notification must be filed under the new license holder.

4. Are local clinical trials required for generic drugs?

Typically, Thailand does not mandate full clinical trials for generic drugs. Instead, a bioequivalence (BE) study is required to demonstrate therapeutic equivalence to the reference product.

5. Can previously approved medical devices in the US/EU be registered faster in Thailand?

Yes, pre-approved medical devices from the US (FDA) or EU (European Medicines Agency/Notified Bodies) can be registered faster in Thailand through the concise evaluation pathway. This allows the companies to submit a registration application based on the evidence of approval from a reference regulatory agency such as US FDA or EU notified bodies.