Before placing any pharma product in the market, companies must secure marketing authorization. This applies whether the product is imported or locally manufactured.
Thailand’s Drug registration process depends on the product category — modern drugs, traditional medicines, or biologics. Each has a different set of documents and timelines. For foreign manufacturers, working with a local representative is mandatory. Dossiers are usually submitted in ACTD format. GMP compliance is checked as part of the process.
Let’s look at how the pharmaceutical product registration in Thailand works and what are regulations guidelines by Thai FDA.
Who Actually Approves Drugs in Thailand?
All drug registrations in Thailand are handled by a single authority — the Thai FDA, under the Ministry of Public Health.
If your company is not based in Thailand, there’s one thing to know right away: you can’t submit the application yourself. Only a local company can file for drug registration. That’s where a Marketing Authorization Holder (MAH) comes in. This local representative acts on your behalf and takes care of all the paperwork and coordination.
The Thai FDA acts as the single decision-maker. Whether it’s a new drug application, clinical trial request, or a label change, nothing moves forward without their review and approval.
Pharma Product Classification in Thailand:
In Thailand, drugs are mainly split into four types. You’ve got regular pharmacy meds you can buy without a prescription — stuff like paracetamol or antacids. Then there are prescription drugs that need a doctor’s approval, like antibiotics or blood pressure tablets. Herbal and traditional medicines are handled separately since they’ve been around for ages and are considered lower risk. Lastly, household remedies — basic items like menthol balms — are treated differently under Thai law.
Also Read: Medical Device Registration In Thailand
Pre-registration Requirements:
Before starting the registration, foreign companies must submit:
- A letter naming their local representative
- A product sample
- Proof that the manufacturing site follows GMP standards
The Thai FDA reviews these to confirm the product’s source and basic quality before allowing full registration.
List of Documents Required by TFDA:
The documents required for each module of the regulation process may vary depending on the type of product. However, a pharma registration dossier may include:
- Product information and labeling
- Quality control and manufacturing details
- Preclinical and clinical study data
- Stability testing data
- Bioequivalence or bioavailability study results
- GMP compliance certificate
- Pharmacovigilance plan
- Risk management plan
- Import and distribution license
Thailand FDA Pharma Registration Process:
To register a drug in Thailand, companies follow a few key steps:
- Send the documents – This includes product details, test reports, and proposed labels.
- Wait for review – Thai FDA checks if everything’s complete and meets local rules.
- Factory check – Sometimes, they inspect the site to make sure it meets GMP standards.
- Get approval – If all’s in order, the drug gets the green light for sale in Thailand.
Though it involves different regulatory steps for a pharma product by Thai FDA, it’s necessary to get compliant and market-ready in Thailand.
GMP Inspection Requirements:
During the registration process, the TFDA may conduct GMP inspections of the manufacturing facilities to verify compliance with global quality standards.
Also Read: Food Supplements Registration In Thailand
TFDA Labeling Requirements:
In Thailand, product packaging must follow strict TFDA guidelines, especially for prescription drugs Thailand. Labels should be in Thai and clearly display:
- Product name and active ingredient
- Dosage form and strength
- Usage, warnings, and storage info
- Labeling errors are one of the most common causes of delays in Thailand drug registration.
Thai FDA Clinical Trial Requirements:
When submitting clinical trial data to Thai FDA, it’s not just about following ICH-GCP. They often want to see if Thai patients were involved or if the data reflects the local population. If not, they might ask for a local bridging study. Before starting a trial, it’s also necessary to register it with the Thai Clinical Trials Registry and get ethics clearance.
Testing Requirements:
Testing is an integral part of ensuring the quality and safety of pharmaceutical products. Pharmaceutical companies conduct comprehensive and stringent tests to evaluate various aspects such as stability, purity, potency, and bioequivalence, among others. These tests are performed in accordance with the guidelines set by Good Laboratory Practice (GLP), which ensures that the testing procedures adhere to the highest standards and produce accurate and reliable results. By complying with these standards, pharmaceutical companies can confidently deliver products that meet the strictest quality and safety requirements.
TFDA Foreign Testing:
Foreign clinical or quality testing may be accepted if conducted in FDA-recognized countries and meets TFDA submission standards. This especially benefits companies from the EU or US, whose approvals are often referenced in the Thailand FDA new drug registration process.
Recognition of EU/US Approvals:
To streamline registration, having prior approvals in Europe or the US can accelerate TFDA evaluation. This helps especially with Thailand pharmaceutical companies seeking quick market access for imported drugs.
Import and Distribution Requirements:
Once approved, a pharma product must obtain an import license and follow distribution rules. Many pharmaceutical importers in Thailand overlook this final step, but it’s essential to avoid post-launch compliance issues.
Timelines:
Timelines vary based on dossier type. Pharmaceutical registration in Thailand can take 6 months to 2 years, especially for innovator drugs or when eCTD submission is involved.
Associated Fees:
The fees for various licenses and evaluations in the pharmaceutical industry are as follows:
(1) Modern Drug Manufacturing Licenses: THB 8,500 per license.
(3) Modern Drug Selling Licenses (Wholesale): THB 2,000 per license.
(4) Modern Drugs Import License: THB 38,000-88,000 per license.
(5) Technical Document Evaluation for New Drug Registration: THB 155,000 – 395,000 per product.
Post-Marketing Activities:
After a pharmaceutical product is approved and launched in the market, companies need to comply with post-marketing activities. These activities include pharmacovigilance to monitor and report adverse drug reactions. Companies may also need to apply for variations to the product registration, such as changes to the dosage form or strength. Additionally, periodic renewal of the product registration is required by the TFDA. Compliance audits may also be conducted to ensure ongoing adherence to regulations.
Conclusion:
For pharma businesses eyeing the Thailand market, regulatory affairs can either be a hurdle or a stepping stone. It all depends on how well the process is managed. With the right insights and local knowledge, approval becomes much smoother.
Artixio supports pharma companies in getting their products successfully registered in Thailand.
