Marketing Authorization and Regulatory Requirements for Exporting Drugs to Thailand

Oct. 25th, 2023

Dr. Atthachai Homhuan / Kittiya Nopparatrungroj


At about 6.6% of GDP, Thailand’s healthcare expenditure is relatively high. Accordingly, the market value of pharmaceuticals in Thailand has grown rapidly. The incidence of chronic non-communicable diseases and increase in the elderly population are key factors driving the industry in Thailand. However, the drug industry also faces challenges in the form of more regulatory requirements to obtain marketing authorization licenses for drugs to be imported.

In this webinar, Dr. Atthachai Homhuan, director of regulatory affairs at Tilleke & Gibbins, will provide an overview of Thailand’s pharmaceutical market and explain important aspects of its regulatory framework. Then Ms. Kittiya Nopparatrungroj, a consultant in Tilleke & Gibbins’ regulatory affairs practice group, will walk through the requirements for obtaining a marketing authorization and fulfilling other importation requirements in Thailand. Finally, the speakers will describe the pricing scheme and reimbursement for pharmaceutical products in Thailand.

1. Analysis of Thailand’s Pharmaceutical Market2. Regulatory Framework and Competent Authority

  • 2.1 Drug Act, as amended, and relevant regulations
  • 2.2 Competent Authority

3. Drug Product Requirements

  • 3.1 Definition and Classification
  • 3.2 Good Manufacturing Practice (GMP) and overseas manufacturing site
  • 3.3 How to obtain a marketing authorization license for a drug product

4. How to Export Drug Products to Thailand

  • 4.1 Import requirements
  • 4.2 Advice for importers and exporters

5. Pricing of Drug Products and Reimbursement Scheme


Date Time (GMT+8) World Clock Language
2023-10-25 21:00 ~ 22:00 London: 14:00-15:00

New York: 9:00-10:00



Dr. Atthachai Homhuan

Regulatory Affairs Director of Tilleke & Gibbins

Dr. Atthachai Homhuan is the director of the regulatory affairs department at Tilleke & Gibbins. Dr. Atthachai prepares healthcare product dossiers for registration and he helps international companies develop market entry strategies for countries in Southeast Asia. His broad experience allows him to evaluate the feasibility of product registrations, conduct plant audits, and coordinate pre-clinical and clinical trials in accordance with international guidelines and standards.

Kittiya Nopparatrungroj

Regulatory Affairs Consultant

Kittiya Nopparatrungroj is a consultant in Tilleke & Gibbins’ regulatory affairs team in Bangkok and is a licensed pharmacist in Thailand. She advises and assists international and local clients in the pharmaceutical, medical device, and broader life sciences industries on market entry, obtaining and maintaining marketing authorization licenses, advertising and marketing regulations, and other related regulatory affairs matters.

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