Pharmaceutical Regulatory Affairs Consultant in Thailand

Artixio provides comprehensive regulatory affairs consulting support right from regulatory strategy to product registration globally, efficient regulatory operations and post marketing maintenance.

Services We Offer

Your Regulatory Affairs Partner for Thailand’s Pharma Market

Not every regulatory path in Thailand is straightforward. That’s where Artixio comes in. We support pharmaceutical regulatory affairs in Thailand with practical, on-ground experience—not just theory. We work closely with pharma companies targeting Thailand’s market—whether it’s for first-time registration, variation filing, or compliance after audits.

Thai FDA’s approach differs from other ASEAN countries. Timelines can vary depending on the pharma product type and how well the dossier matches ACTD formatting. We help clients avoid common rejection points—like mismatched module structures or missing Thai translations.

From drug master file (DMF) support to labeling updates after approval, our team steps in wherever needed. We’re familiar with local expectations and communicate directly with the Thai FDA, so you don’t lose time on back-and-forth corrections.

Pharmaceutical Regulatory Compliance Support in Thailand (ThaiFDA)

The central regulatory body of Thailand is Thai Food and Drug Administration (ThaiFDA) which is under the Ministry of Public health. It oversees for regulatory activities for pharmaceuticals, cosmetics food and medical devices. In addition, they also monitor clinical trials ensuring the product safety and later conducts the post marketing surveillance.

Whether you’re filing for your first drug registration or managing lifecycle updates, we know what Thai FDA expects—and where companies often go wrong. Our team has handled regulatory affairs for pharmaceutical products in Thailand across branded generics, complex injectables, and reformulations.

Classification of Pharmaceuticals in Thailand

The pharmaceutical drug products in Thailand are classified as-

Over the counter Drugs (OTC)- the medicines that can be bought without the presence of any prescription and can be self for self-treatment.

Prescription Drugs- these are the medicines that can only be purchased when doctor’s prescription is available. They are used for specific indications and may carry side effects as well.

Complementary and traditional medicines- these are the medicines that are considered as herbal and have use in Thai culture.

Pre-Registration process

The applicant must obtain license from Thai FDA to sell and import drugs in Thailand. The applicant must complete its pre-clinical research and must ensure the safety and efficacy of the product. Next step will be conducting the clinical trials under strict protocols and determine the product performance.

Registration Process

Only approved license holders are entitled for drug registration application. Once the pre -clinical and clinical trials are completed and data is collected the applicant must apply for the dug registration process. The application will comprise of composition of the drug, manufacturing process, efficacy and safety data from the trails, and labelling essentials.

Registration Process for Pharmaceuticals in Thailand (ThaiFDA)

The registration application must include the below mentioned information: –

Name and address of importer or manufacturer
License to importer or manufacturer
Name and description of the product
Formula of the drug
Packaging
Labelling and artwork

Document submission

applicant must submit the documents as the ThaiFDA regulatory requirement which will comprise all the trails data, labelling information and safety reports.

Review and Evaluation

ThaiFDA will review and assess all the submitted documents and check for its compliance with the regulations.

Inspection

the facility for the manufacturing might go through inspection for ensuring the GMP compliance.

Approval

if ThaiFDA considered the application and that the drug product is safe and efficacious it will give its approval, and the drug will be marketed in Thailand.

The timeline for drug product registration in Thailand usually takes from 12 months to 2 years based on the product complexity.

Artixio assists pharmaceutical companies with Regulatory Affairs Strategies in Thailand

Collaborate with Artixio’s Thailand Expertise with Seamless Global Delivery

Successful Approvals and Product Lifecycle Maintenance for 300+ products
Diverse Products Experience across Complex Products Categories and Therapeutic Areas
Strong Regional Expert with 25+ years of experience
Proven Experience in End-to-End Product Value Chain from Concept to Commercialization
Health Authority Experience in Navigating through Complex, often Ambiguous Regulations
ISO 9001:2015 quality standards governed services
Customer focused, flexible services and solutions
Flexible Business Model including project based, managed services and FTE staffing model
Hybrid-Local-Centralized Support across Regulatory functions

FAQs

Who are eligible for registration of product in Thailand?

A license holder (representative) or a local Thai company can apply or the drug registration in Thailand. The foreign firms must assign a local distributor or agent for product registration that they must be registered with Thai FDA.

What I the language required for product labels?

All the labels which are consumer facing must be in Thai language which will include instructions, ingredients, warning and details of manufacturers.

What is the validity for drug registration in Thailand?

The product is registration is valid for 5 years for a drug product.

For generic drug registration is the bioequivalence data required?

Yes, bioequivalence data is required for generic drug registration.

What is the fess for drug registration in Thailand?

Yes, the Thai FDA charge fees based on the product and registration process. The fees range is generally from 50,000 THB to 200,000 THB (USD 1500-6000)