Medicinal Products Regulatory Support in Thailand


The pharmaceutical market 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. Pharmaceutical product registration in Thailand is regulated by the Thai Food & Drug Administration (FDA), which operates under the guidance of the Ministry of Public Health.

With updated Regulatory Intelligence over the new system of Regulatory approval process in Thailand, 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.

Medicinal Products Classification

As per the Regulatory approval process in Thailand, medicinal products are divided into four (04) categories, such as:

  • Specially Controlled Drug
  • Dangerous Drug
  • Drugs that are neither Specially Controlled nor Dangerous
  • Household Remedy Drugs

Medicinal Product Registration

As per the Regulatory approval process in Thailand, 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 FDA, relevant committees in charge of the registration of the medicinal products in Thailand carry out the dossier screening (completeness review + technical review). After the review process by the experts, queries are issued by the FDA Thailand 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 approval for the drug.

Freyr Expertise

  • Authorized local representation
  • Pharmaceutical product classification
  • Pharmaceutical Regulatory Affairs consulting and services
  • Pharma market access
  • Thailand FDA registration
  • End-to-end pharmaceutical product registration
  • 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
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