Regulatory Overview

Overview of Regulatory in Thailand

More than 50% of the pharmaceutical market in Thailand are comprised of imported products.   Foreign companies importing finished products or raw materials into Kingdom of Thailand  are required to obtain an import license from the Ministry of Health.

The Food and Drug Administration  (FDA) is responsible for ensuring the safety, quality and efficacy of pharmaceuticals products in Thailand. The FDA also handles the drug application review process and grants drug approvals in the form of a marketing authorization license.

Drug Registration Process

New Application vs. Variation Application

The drug registration process is divided into two categories: (1) new drug applications and (2) drug variation applications. A new drug application is required for the following types of products or product changes: a new active ingredient, a new derivative or combination, or a new dosage form, strength or indication. A drug variation application is needed for drugs which have already been granted a marketing authorization license.

Pre-Registration

The drug registration process consists of two stages: (1) pre-registration and (2) submission of the  registration dossier.

 The pre-registration process is conducted to determine the application review and evaluation pathway. The FDA reviews drug applications via one of three      pathways (Path I, II or III). Path I includes drug applications for products used to treat serious or life-threatening diseases, or for essential generic drugs for        public health programs. New drugs already approved in certain designated countries may qualify for the Path II registration process. Any drug applications for    products that do not qualify for Path I or Path II evaluation processes will be reviewed via the Path III process.

 Generally, applications are review within the following timeframes:(standard)

 Path I: 100 working days

 Path II: 150 working days

 Path III: 300 working days for new drugs; for all other drugs, around 80 working days

 Registration Dossier Requirements

 The registration forms and accompanying documents must be in Thai language. 

 The following lists some of the documents and information required for the dossier:

  • Good Manufacturing Practice (GMP) certificate
  • Specifications and method of analysis
  • Pharmacodynamic, pharmacokinetic and toxicity data
  • Clinical trial report
  • Labeling and packaging materials, including materials for the label, box, outer packaging, blister strip and catch cover
  • Product insert/leaflet
  • Product samples

Approval Process

The head of the FDA is responsible for issuing the marketing authorization approval/non-approval decision. In some cases, the FDA may request additional data in order to determine the product approval/non-approval. In this situation, the applicant will have 120 days to submit this requested information. If the applicant is unable to provide the data within the given timeframe, the application will be rejected. However, the applicant has the option of resubmitting the dossier as a new registration application.

Non-approval Appeals

If an application is reviewed by the FDA and the FDA decide that the product cannot be approved, the applicant has the option of submitting an appeal. The written appeal should be submitted within six months from the date of application being rejected. The appeal should be accompanied by additional product data in order to better justify approval of the product. Applicants are allowed a maximum of two appeals

 

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