Navigating Biologic Product Registration in Thailand: TFDA Requirements, Procedures, and Validation Process

TFDA Requirements for Summary Product Characteristic (SPC)

Thailand, governed by the Drug Act B.E.2510. The key points are as follows

1. 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. 

2. 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. 

3. Variation Approval

Any variation to a marketing authorization requires prior approval from TFDA. 

4. 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. 

5. 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. 

6. 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. 

4 Procedure for Submission of the Application for A TFDA Marketing Authorization Decision 

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.” 

1. Before Submission 

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:  

• a draft SPC;  
• an indication on the number of strengths / pharmaceutical forms / pack sizes (if already known);  
• if applicable, their intention to present any existing Vaccine Antigen Master File (VAMF) or Plasma Master File (PMF) Certificates  
• the details of proposed manufacturing sites for the finished product and active substances  
• a specification of any regulatory issues or difficulties already identified which may require clarification or detailed consideration 

2. Submission of the Application  

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. 

3. Dossier to be Submitted  

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: 

• a document identifying the person for pharmacovigilance who will be the contact person for any specific pharmacovigilance issues, together with a curriculum vitae and contact details  

• a document identifying the contact person responsible for any quality issues including its contact details 

4. Validation by the TFDA  

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. 

4.1. Positive outcome of the validation 

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. 

4.2. Negative outcome of the validation 

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. 

4.3. Management of applications 

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. 

4.4. Need for samples and sample analysis 

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.