Thailand’s rapidly evolving healthcare ecosystem offers immense opportunities for pharmaceutical companies aiming to expand in the Asia-Pacific region. As a critical entry point into emerging Asian markets, Thailand has established a structured drug registration process governed by the Thai FDA (Food and Drug Administration) under the Ministry of Public Health.
At RABT Global, we bring specialized regulatory expertise to support global pharmaceutical companies in obtaining market access in Thailand. Backed by current regulatory intelligence and a deep understanding of Thai FDA protocols, our team ensures seamless compliance across all stages of product registration.
Classification of Medicinal Products in Thailand
According to Thai FDA regulations, medicinal products are classified into four categories:
- Specially Controlled Drugs
- Dangerous Drugs
- Drugs That Are Neither Specially Controlled Nor Dangerous
- Household Remedy Drugs
Correct classification is essential for determining the registration pathway and documentation requirements.
Step-by-Step Process: Pharmaceutical Product Registration
Step 1: Import License Application
Before initiating a registration, companies must obtain an Import License to legally bring pharmaceutical products into Thailand. Required documentation includes:
- Completed application form
- Drug composition/formula
- Literature and product information
- Labeling and packaging details
Step 2: Credential Certificate Application
Once the Import License is approved, the next step is to apply for a Credential Certificate. The dossier submitted to the Thai FDA must include:
- Valid Import License
- Product sample
- Clinical data (if applicable)
- Safety and efficacy studies
- Pharmacological and toxicological information
- Certificates of Free Sale and GMP compliance
- Complete labeling and packaging details
The Thai FDA conducts a thorough dossier review, including a completeness check and a technical evaluation. Following this, applicants may receive queries that must be addressed before final approval is granted.
Why Choose RABT Global?
Our pharmaceutical regulatory services are tailored to ensure end-to-end compliance, enabling faster market entry in Thailand. Here’s how we help:
- Local Representation in Thailand
- Medicinal Product Classification Assistance
- Pharmaceutical Regulatory Strategy and Consultation
- Thailand FDA Drug Registration and Dossier Submission
- Market Access Support
- Gap Analysis and Compliance Review
- Scientific Report Generation for Preclinical Submissions
- Import License Management
- Regulatory Liaison and Query Handling
- Product Registration Holder Change Services
- On-Demand Regulatory Consulting
Accelerate Your Product Launch in Thailand
Whether you’re a first-time entrant or expanding your existing portfolio, RABT Global ensures a compliant, efficient, and expert-guided registration journey in Thailand.
Contact us today to get started with your pharmaceutical product registration.
