Marketing Authorization and Regulatory Requirements for Exporting Drugs to Thailand
[Wednesday, 25th Oct 2023]
Marketing Authorization and Regulatory Requirements for Exporting Drugs to Thailand
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 noncommunicable 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.

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1. Analysis of Thailand’s Pharmaceutical Market

2. 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

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. Atthachai also reviews healthcare product labeling for food, cosmetics, medical devices, and drug products in Thailand and other Southeast Asian countries. Atthachai also assists chemical, life sciences, pharmaceutical, and biotechnology companies to draft and review their patent claims and specifications. He advises patent agents on amending claims and providing responses to office actions. Atthachai frequently drafts counterstatements against opposing parties in trademark and patent applications. His practice also includes advising on pre-litigation and litigation matters involving the life sciences, medical devices, and pharmaceuticals. He has presented before the IP&IT Court as a witness in chemistry and life sciences patent litigation. Prior to joining the firm, Atthachai was a postdoctoral researcher in Japan and China Taiwan, focusing on stem cell therapies and vaccine development. He applied his technical expertise to the industry when he became a project manager for a Thai vaccine manufacturing company, where he led the firm’s R&D efforts. His industry background also includes serving as a formulation manager at the subsidiary of a well-known American pharmaceutical innovator, where he was a group leader in charge of the company’s R&D and production functions. Atthachai holds a PhD in Pharmaceutical Technology from Thailand’s Mahidol University, and he frequently lectures on pharmaceutical and chemical patents at universities across Thailand. He has completed the South East Asian Drafting Training Couse, enabling him to prepare patent applications and claims.
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. She also regularly prepares and reviews registration dossiers, and evaluates the feasibility of product registrations, advertisements, and labeling material for pharmaceutical products and medical devices. Kittiya regularly authors articles covering updates of Thai laws and regulations applicable to the pharmaceutical and medical device industries. In addition, she has participated in several seminars and webinars on the same topics. Kittiya graduated with a bachelor’s degree in Pharmaceutical Science from Mahidol University. During her studies, she completed internships with a local drug manufacturer and a local cosmetics manufacturer in Thailand. She also received a scholarship to intern at the Analytical Chemistry Institute of Johannes Kepler University in Austria, where she conducted research on steroid hormones from placenta extract.
If you have any question about this webinar, please contact us:
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