Regulatory Authority

Thai Food and Drug Administration (TFDA)

Link for Regulatory Authority

https://en.fda.moph.go.th/

Mail:drug-sarabun@fda.moph.go.th

Local Authorised

Yes

Classification of Medical Devices

• Specially controlled drugs: Highest level of restriction, requiring special permissions for importation, production, and distribution.
• Dangerous drugs: Requiring prescription and tight controls on distribution.
• Non-dangerous drugs: Available over the counter, but regulations still apply.
• Household remedies: Traditional remedies with minimal regulation.
  

  Preparation and Documentation

  Administrative Documents

  Documents Required for Pharmaceutical Product Approval in Thailand:

  1. Application Form:

  Complete the application form provided by the Thai Food and Drug Administration (TFDA).

  2. Copy of Valid Certificate of Brand Name Clearance:

  Provide a copy of the certificate confirming the clearance of the brand name for the pharmaceutical product.

  3. Certificate of a Pharmaceutical Product (COPP):

  Submit the Certificate of a Pharmaceutical Product issued by the regulatory authority in the country of origin.

  4. Good Manufacturing Practice (GMP):

  Include evidence of compliance with Good Manufacturing Practice standards for the pharmaceutical product.

  5. License for Pharmaceutical Manufacturing:

  Present a valid license for pharmaceutical manufacturing issued by the relevant authority.

  6. Site Master File (SMF):

  Provide a comprehensive Site Master File detailing information about the manufacturing site.

  7. Permission for Manufacturing & Marketing in the Country of Origin:

  Submit documentation indicating permission for both manufacturing and marketing in the country of origin.

  8. Letter of Authorization (LOA):

  Include a Letter of Authorization allowing the submission and processing of the application.

  9. Labelling Documents:

  Present detailed labelling documents in accordance with TFDA regulations.

  10. Patent Information:

  Provide information on any patents related to the pharmaceutical product.

  11. Summary of Product Characteristics (SPC), Patient Information Leaflet (PIL):

  Include documents outlining the summary of product characteristics and patient information       leaflet.

  12. Mock-Up and Specimen:

  Submit mock-up and specimen samples of the pharmaceutical product packaging.

  13. Environmental Risk Assessment (if applicable):

  Include an Environmental Risk Assessment if required by TFDA regulations.

  Drug Product

  1. Description & Composition:

  Provide a detailed description of the pharmaceutical product, including its composition, active ingredients, and any excipients used.

  2. Pharmaceutical Development:

  Include information on the pharmaceutical development process, covering formulation, design, and optimization of the product.

  3. Manufacture:

  Present comprehensive details on the manufacturing process, ensuring compliance with Good Manufacturing Practice (GMP) standards.

  4. Quality Control (QC) of Excipients:

  Outline the quality control measures applied to the excipients used in the formulation.

  5. QC of Finished Product:

  Describe the quality control procedures implemented for the finished pharmaceutical product, including testing methods and acceptance criteria.

  6. Reference Standard:

  Specify the reference standard used for comparison to ensure the consistency and quality of the pharmaceutical product.

  7. Container Closure System / Packing:

  Provide information on the container closure system and packaging materials used, ensuring they meet safety and quality standards.

  8. Product Stability:

  Include data and studies on the stability of the product under various conditions, demonstrating its shelf life and efficacy over time.

  9. Product Interchangeability:

  Address the interchangeability of the product concerning other similar products in the market, ensuring clarity on potential substitutions.

  Non-Clinical Documents

  1. Non-Clinical Overview
     2. Literature References

  Clinical Documents

  1. Clinical Overview
     2. Clinical Study Reports (Only Bioequivalence)

Registration Timeline

Timeline

• • • Depends on several factors: Type of product, chosen pathway, data completeness, and FDA workload.
    • General estimates:
      • New Chemical Entities (NCEs): 12-18 months (Full Pathway), 6-12 months (Simplified Pathway).
      • Generics: 6-12 months (Standard/Simplified Pathways).
      • Other types: Consult FDA for specific information.
        

        Validity

        In Thailand, the validity of licenses for pharmaceutical products depends on the type of license and the date it was issued:

        1. Marketing Authorization (MA):
        • New MAs: Valid for 7 years after the issuance date.
        • MAs issued before October 13, 2019:
          • Originally had indefinite validity.
          • Expire 5 years after October 13, 2019: If not renewed before this date, the product cannot be marketed anymore.
        2. Import License:
        • Valid for 1 year from January 1 to December 31.
        • Renewal required annually.
        3. Manufacturing License:
        • Valid for 5 years from the issuance date.
        • Renewal required before expiry.
        4. Other Licenses:
        • Depending on the type of license, validity can range from 1 year to 5 years. Always check the specific license for its expiration date.

        Fees

        • New chemical drugs:
          • Application/Dossier Screening Validation Fee: 2,500 Thai Baht
          • Certificate of Registration Fee: 2,000 Thai Baht
        • Vaccines:
          • Application/Dossier Screening Validation Fee: 1,000 Thai Baht
          • Certificate of Registration Fee: 2,000 Thai Baht

        Generic Drugs

        Generic Drug Registration Process

        Definition: Pharmaceutical products sharing identical active ingredients and dosage forms as original products but produced by different manufacturers are recognized as generics.

        Registration Requirements

        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.

        Registration Procedure

        Application to the FDA

        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.

        FDA Registration

        The licensed applicant must then secure FDA registration for the medicine to market and sell it in Thailand.

        Details to be Submitted

        Manufacturing methods.

        In-process controls.

        Specifications of the active ingredients.

        Excipients used in the production process.

        Requirements & Procedure for Licensing Generic Pharmaceuticals in Thailand

        1. Regulatory Body: The Drug Control Division of the TFDA (Thai Food and Drug Administration) is responsible for registration, licensing, surveillance, inspection, and adverse event monitoring of all pharmaceuticals and pharmaceutical firms in Thailand.
        2. Application Format: The ACTD (ASEAN Common Technical Document) format and any extra requirements particular to a country are used for submission and medication registration.

           Type of Application: General medications, such as generics, new medicines, and new generics, have different registration criteria than traditional drugs.

           Types of Generic Medications

           1. Generic Drug

           2. New generic medication.

           Generic Drugs

           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.

           Registration Requirements

           • Registration for generic drugs in Thailand is a streamlined process.
           • Applicants need to submit dossiers related to product manufacturing, quality control, and product information.
             

             Procedure

             1. License Acquisition: Companies and individuals intending to enter the drug market must obtain a license from the Food and Drug Administration (FDA) to manufacture, sell, or import drugs in Thailand.
             2. Quality Control Approval: Applicants must seek approval for drug quality control and analytical methods from the Department of Medical Science.
             3. FDA Registration: The licensed applicant then obtains FDA registration for the medicine, allowing them to market and sell the drug in Thailand.
             4. Submission Details:
             • Details about the drug production process, including manufacturing methods, in-process controls, specifications of active ingredients, and excipients used in production, must be submitted.

             New Generic Drugs

             1.  Definition: New generic drugs refer to medicines with the same active ingredients, doses, and dosage forms as those of new compounds registered after 1992.
             2. Additional Requirements: Registrations for new generics require dossiers of bioequivalence studies in addition to the standard requirements for generic drug submissions.

              

             Procedure

             1. Bioequivalence Study Protocol Approval: A protocol for a bioequivalence study must be submitted for approval at the Drug Control Division.
             2. Permission for Import/Manufacture: Applicants seek permission to import or manufacture drug samples.
             3. Bioequivalence Study Execution: The bioequivalence study is conducted according to the approved protocol in a specified government institute.
             4. Registration Application: An application for registration, along with the bioequivalence report and other relevant documents, is submitted.

             For New Generics, Additional Requirements Include

             Bioequivalence Studies Dossiers

             Submission of dossiers related to bioequivalence studies is mandatory.

             Drug Storage Conditions

             Information concerning drug storage conditions must be provided.

             Stability Details

             Comprehensive details on the stability of the drug are also required.

             Generic & New Generic Comparison

             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

             Biologic Product Registration in Thailand

             Requirements for Summary Product Characteristic (SPC):

             • Name of the Medical Product
             • Qualitative And Quantitative Composition
             • Pharmaceutical Form
             • Clinical Particulars
             1. Therapeutic indications
             2. Posology and method of administration
             3. Contraindication
             4. Special warnings and precautions for use
             5. Interaction with other medical products and forms of interaction
             6. Pregnancy and lactation If are pregnant, think may be pregnant or are planning to have a baby or are breastfeeding, ask doctor before taking the vaccine.
             7. Effects on the ability to drive and use machines
             8. Undesirable effects
             • Pharmacological Properties
             1. Pharmacodynamic properties
             2. Pharmacokinetic properties
             3. Preclinical safety data
             • Pharmaceutical Particulars
             1. List of excipients
             2. Incompatibilities
             3. Shelf life
             4. Special precautions for storage
             5. Nature and contents of container
             6. Special precautions for disposal and other handling
             • Bio Similarity studies (In Biosimilar)
             • Marketing Authorisation Holder
             • Marketing Authorisation Number(s)
             • Date Of First Authorisation/Renewal of the Authorisation
             • Date Of Revision of the Text
               

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

               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.

               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.

               • 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.

               • 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.

               • 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.

               • 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.