Drug Registration and Approval Process in Thailand - Overview
Registration of Pharmaceutical products in Thailand has grown significantly in the past few years due to impressive developments in the public healthcare system. Thailand represents a significant growth opportunity for multinational pharmaceutical firms looking to expand their presence in the emerging markets of Asia Pacific. The Drug Registration and Approval Process in Thailand is governed by the Thai FDA under the Ministry of Public Health. The Thailand FDA registration process has become more streamlined in recent years, attracting increased interest from multinational firms.
With updated Regulatory Intelligence over the new system of Thailand drug registration and approval, Freyr assists new market entrants in keeping pace with the improved Regulatory requirements related to registrations, dossier compilation, and submissions for the necessary market authorizations through our robust knowledge of Thai FDA regulatory guidelines.
Medicinal Products Classification in Thailand
As per the Regulatory approval process in Thailand, the Classification of medicinal products in Thailand is categorized into four (04) distinct types:
Specially Controlled Drugs.
- Dangerous Medicinal Products.
- Drugs that are Neither Specially Controlled or Dangerous.
- Household Remedy Drugs.
Correct classification is crucial for a successful Thailand FDA product registration.
Medicinal Product Registration in Thailand
As per the Thailand FDA Drug registration process, the procedure of pharmaceutical product registration is divided into two (02) steps.
Step 1: Application for Obtaining the Import License
For a pharmaceutical product registration in Thailand, the applicant should acquire an Import License to import the drug into the country. Documents required for this application include the application form, drug formula, drug literature, and drug labeling & packaging information.
Step 2: Application for the Approval of the Credential Certificate
For registration with the Thailand FDA, the applicant is required to obtain a Credential Certificate. Documents required for this application include the Import License, drug sample, literature and formula, pharmacological and toxicological study (if applicable), clinical trials, safety and efficacy study (if applicable), Free Sale Certificate, GMP Certificate, labeling & packaging information, etc.
Once the dossier is prepared and submitted to the USFDA, relevant committees in charge of the Pharmaceutical product registration in Thailand carry out the dossier screening (completeness review + technical review). After the review process by the experts, queries are issued by the Thai FDA to the applicant. The applicant then submits a response to the queries from the Thailand FDA, and the second round of review is performed by the experts. Based on these results, the Thailand FDA issues approvals for medicinal products.
Generic Product Registration Support in Thailand
Freyr also provides specialized Generic product registration support in Thailand, assisting clients in meeting bioequivalence, safety, and efficacy requirements per Thai FDA regulations for drug registration.
Pharmaceutical Product Registration in Thailand - Freyr Expertise
- Authorized Local Representation/MAH transfer support in Thailand
- Pharmaceutical Product Classification.
- Pharmaceutical Regulatory Affairs Consulting and Services.
- Pharma Market Access.
- GMP support in Thailand and site registration support in Thailand
- Regulatory pathway assessment and Regulatory strategy support in Thailand
- Thailand FDA Drug Registration.
- End-to-end Pharmaceutical Regulatory Support in Thailand.
- Gap Analysis, Pharmaceutical Dossier Preparation, and Submission to the National Pharmaceutical Regulatory Agency (NPRA).
- Preclinical Services (Generation of Scientific Reports for Regulatory Submissions).
- Import License Application.
- Change of the Product Registration Holder.
- Ad-hoc Regulatory Affairs Consultation.
How Freyr Can Help
Freyr delivers end-to-end support for the Drug Registration Process in Thailand, ensuring compliance with the Thailand Food and Drug Administration guidelines. From securing the Thailand FDA license to navigating the Drug Approval Process in Thailand, we enable seamless Pharma Market Access in Thailand with expert GMP clearance support in Thailand.
We also manage the full Import license process in the Thai FDA, including the Import License Application, and provide strategic assistance with Pricing, reimbursement frameworks, Variation support, and changing the product registration holder in Thailand. With clarity on the Documents required for product registration support in Thailand, Freyr ensures a compliant and efficient registration process.