Pharmaceutical Product Registration in Thailand - Overview
Pharmaceutical product registration 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 Thailand drug registration and approval, 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 in Thailand
As per the Regulatory approval process in Thailand, medicinal products are divided into four (04) categories, such as:
- Specially Controlled Drugs.
- Dangerous Medicinal Products.
- Drugs that are Neither Specially Controlled or Dangerous.
- Household Remedy Drugs.
Medicinal Product Registration in Thailand
As per the Thailand drug registration and approval, 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 USFDA, relevant committees in charge of the Pharmaceutical product registration 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 approvals for medicinal products.
Pharmaceutical Product Registration in Thailand - Freyr Expertise
- Authorized Local Representation.
- Pharmaceutical Product Classification.
- Pharmaceutical Regulatory Affairs Consulting and Services.
- Pharma Market Access.
- Thailand FDA Drug 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.