Thai Food and Drug Administration (TFDA)
Mail:drug-sarabun@fda.moph.go.th
Yes
Documents Required for Pharmaceutical Product Approval in Thailand:
Complete the application form provided by the Thai Food and Drug Administration (TFDA).
Provide a copy of the certificate confirming the clearance of the brand name for the pharmaceutical product.
Submit the Certificate of a Pharmaceutical Product issued by the regulatory authority in the country of origin.
Include evidence of compliance with Good Manufacturing Practice standards for the pharmaceutical product.
Present a valid license for pharmaceutical manufacturing issued by the relevant authority.
Provide a comprehensive Site Master File detailing information about the manufacturing site.
Submit documentation indicating permission for both manufacturing and marketing in the country of origin.
Include a Letter of Authorization allowing the submission and processing of the application.
Present detailed labelling documents in accordance with TFDA regulations.
Provide information on any patents related to the pharmaceutical product.
Include documents outlining the summary of product characteristics and patient information leaflet.
Submit mock-up and specimen samples of the pharmaceutical product packaging.
Include an Environmental Risk Assessment if required by TFDA regulations.
Provide a detailed description of the pharmaceutical product, including its composition, active ingredients, and any excipients used.
Include information on the pharmaceutical development process, covering formulation, design, and optimization of the product.
Present comprehensive details on the manufacturing process, ensuring compliance with Good Manufacturing Practice (GMP) standards.
Outline the quality control measures applied to the excipients used in the formulation.
Describe the quality control procedures implemented for the finished pharmaceutical product, including testing methods and acceptance criteria.
Specify the reference standard used for comparison to ensure the consistency and quality of the pharmaceutical product.
Provide information on the container closure system and packaging materials used, ensuring they meet safety and quality standards.
Include data and studies on the stability of the product under various conditions, demonstrating its shelf life and efficacy over time.
Address the interchangeability of the product concerning other similar products in the market, ensuring clarity on potential substitutions.
In Thailand, the validity of licenses for pharmaceutical products depends on the type of license and the date it was issued:
Definition: Pharmaceutical products sharing identical active ingredients and dosage forms as original products but produced by different manufacturers are recognized as generics.
Dossier on Manufacturing and Quality Control
Generic drug registration necessitates the submission of dossiers focusing on manufacturing processes and quality control, accompanied by comprehensive product information.
Companies or individuals aspiring to introduce a drug into the market must acquire a license from the FDA, granting permission for drug manufacturing, selling, or importing in Thailand.
Quality Control and Analytical Methods Approval:
Application for approval of drug quality control and analytical methods is submitted to the Department of Medical Science.
The licensed applicant must then secure FDA registration for the medicine to market and sell it in Thailand.
Manufacturing methods.
In-process controls.
Specifications of the active ingredients.
Excipients used in the production process.
Type of Application: General medications, such as generics, new medicines, and new generics, have different registration criteria than traditional drugs.
1. Generic Drug
2. New generic medication.
Definition: Generic drugs are pharmaceutical products with the same active ingredients and the same dosage forms as those of the original brand-name products. However, they are manufactured by different manufacturers.
Submission of dossiers related to bioequivalence studies is mandatory.
Information concerning drug storage conditions must be provided.
Comprehensive details on the stability of the drug are also required.
Type |
Dossier Requirements |
Process |
Timeline |
Generic drug |
1. Product Manufacturing 2. Quality Control 3. Product Information |
I. Obtain a license from the FDA to manufacture, sell or import drugs, II. Application for approval of drug quality control and analytical methods, III. Obtain FDA registration for the medicine to market and sell the drug in Thailand |
4 Months |
New Generic Drug |
1. Bioequivalence Studies, 2. Product Manufacturing 3. Quality Control, 4. Product Information |
I. A protocol on bioequivalence study for approval at the Drug Control Division, II. Obtain a license from the FDA to manufacture, sell or import drugs, III. Application for approval of drug quality control and analytical methods, IV. Obtain FDA registration for the medicine to market and sell the drug in Thailand |
5-6 Months |
Legal Basis and Scope
Article 79 of the Drug Act mandates that no drug can be manufactured or imported into Thailand without obtaining marketing authorization from the Thai Food and Drug Administration (TFDA).
Articles 80, 81, and 82 of the Drug Act specify the application dossier requirements, including quality, non-clinical, and clinical information following the ASEAN Common Technical Documents (ACTD) or ICHCTD standards.
Application Particulars:
The marketing authorization application must include details such as trade name, formulation, pack size, analytical method, label, product leaflet, and other documents as outlined in the Ministerial Regulation.
Variation Approval:
Any variation to a marketing authorization requires prior approval from TFDA.
Procedural Mechanism:
The procedures for marketing authorization applications, variation requests, and the issuance of credential certificates align with Ministerial Regulation No.18 (B.E.2525) under the Drug Act B.E. 2510.
Role of Drug Committee:
Article 10 (1) of the Drug Act assigns the Drug Committee the duty to provide advice or justification for permitting the manufacturing, sale, or import of drugs into Thailand, including their marketing authorization.
Focus on Vaccines:
The guideline specifically addresses procedural aspects related to the marketing authorization of vaccines.
A vaccine is defined as an immunogen intended to stimulate the immune system for disease prevention, amelioration, or therapy. It may take various forms, including live attenuated preparations, inactivated whole organisms, recombinant DNA-derived immunogens, and more.
Administrative and scientific
Administrative and scientific advice is available at various stages of the drug development process. It can be sought during initial development, before submitting a marketing authorization application, or in the post-opinion phase.
Before submitting an application for marketing authorization to the TFDA, applicants can request a pre-submission meeting. This meeting allows discussions on procedural, regulatory, or legal issues related to the proposed submission. To request such a meeting, applicants need to use the “Pre-Submission Meeting Request Form.”
At least six months prior to submission of an application for Marketing Authorization decision, applicants should notify the TFDA of their intention to submit an application and give a realistic estimate of the month of submission. In that notification applicants should include:
The applicant shall submit the application at the One Stop Service Center (OSSC), TFDA a temporary permit number is issued to the applicant, and verification is completed within 30 calendar days.
Supporting documents must be submitted in electronic Common Technical Document (eCTD) or other electronic submission platforms as appropriate. If the applicant wishes to use the VAMF or PMF certificate included in the application, the applicant must provide a valid certificate of conformity with the VAMF or PMF in accordance with the EMEA Directive 2003/63/EC Part III and the accompanying assessment report must be provided Use relevant VAMF and PMR data. In the case of vaccines containing or consisting of genetically modified organisms (GMOs), the request must be accompanied by documentation from the competent authorities for the intentional release of GMOs into the environment. In addition, the applicant must provide evidence of the establishment of the applicant and future marketing license holder in the Kingdom of Thailand, as well as documents showing the ability and commitment to perform all the responsibilities required of the marketing license holder, in particular:
During verification, the TFDA PTL may determine the need for actions related to items such as GMP testing, samples for analysis, GCP testing, communication with environmental authorities, and data integrity. If TFDA needs additional data, information, or clarification to complete document approval, it will contact the applicant and request to provide such data, information, or clarification within a specified deadline.
If the result is positive, the TFDA has 60 days the applicant must notify in writing that the verification has been completed. Ask external TFDA experts to send 4-7 copies of the document to TFDA PTL. Applicants must also enter additional data. Information provided during the verification of supporting documents. The evaluation plan adopted by TFDA will be attached to the letter. Confirm positive validation results. Individual arrangements must create a PTL for the copies have.
In the event of a negative validation outcome, where the requested data, information, or clarifications are not provided, the applicant will receive written notification. If the application cannot undergo validation, the applicant will be given the option to either retrieve the dossier or authorize its destruction by the TFDA. Initiating a new procedure becomes necessary if the applicant plans to submit a complete dossier to the TFDA in the future.
Data Entry into Tracking System: Once validated, product details are recorded in the TFDA tracking system using a numbering system that provides clear identification throughout the product’s life cycle, including applications for marketing authorization, variations, and transfers.
Identification of Vaccine Applications: Applications for TFDA marketing authorization of vaccines can be identified by the invented name or, if available, the international non-proprietary name (INN)/common name of the active substance(s) combined with the applicant’s name. For administrative purposes, each application is assigned a core number, consisting of four sections: 1A9000X/year, 2A9000X/year, 1B9000X/year, 2B9000X/year, 1C9000X/year, 2C9000X/year. Here, 1 represents one active substance, 2 represents more than one active substance, A stands for manufacture, B for repack, and C for import.
No Initial Sample Requirement: Applicants are not required to submit samples of the proposed vaccine at the time of application submission.
TFDA Request for Sample Testing: TFDA encourages applicants to submit vaccine samples promptly for testing at the Division of Biological, Department of Medical Sciences. This early submission helps ensure timely testing.
Test Protocol Specification: The National Control Laboratory (NCL) at the Institute of Biological, Department of Medical Sciences, in collaboration with TFDA, will outline a test protocol. This protocol includes details such as sample types, sample quantity, batch numbers, specified tests, and the methods and specifications to be used.
Reporting Test Results: Upon completion, the test results are reported to the TFDA Product Team Leader (PTL). These results play a crucial role in the finalization of the TFDA Assessment Report.
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