Atthachai Homhuan

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Director, Regulatory Affairs

Biography

Dr. Atthachai Homhuan is the director of the regulatory affairs group at Tilleke & Gibbins. He assists biotechnology, chemical, life sciences, and pharmaceutical companies to draft and review patent claims and specifications and advises patent agents on amending claims and providing responses to office actions. Atthachai frequently drafts counterstatements against opposing parties in trademark and patent applications and 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. Based on his expertise, he is recognized as a leading patent lawyer in Thailand by IAM Patent.

In addition to patent work, Atthachai prepares healthcare product dossiers for registration and 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 preclinical 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.

Prior to joining the firm, Atthachai was a postdoctoral researcher in Japan and 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 the group leader in charge of the company’s R&D and production functions.

A Thai-licensed attorney, 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 FICPI Southeast Asian Drafting Training Course.

Experience

Assisted pharmaceutical companies in drafting sale and purchasing agreements and held discussions with the Ministry of Public Health with regard to the purchasing agreements of COVID-19 drug products.
Advised pharmaceutical companies about the Thailand Emergency Use Authorization (EUA) approval requirements of COVID-19 drug products and vaccines.
Revised guidelines for Thai patent officers examining chemical and pharmaceutical patents.
Implemented a quality-control system and addressed GMP-related topics for the manufacturing of vaccines. This involved working closely with the Department of Medical Sciences of the Thai FDA with regard to biohazard manufacturing and audits, in order to obtain approval.
Worked with companies in the agricultural and chemicals industries with regard to complaints on substandard products raised by the Ministry of Agriculture.
Reviewed clinical trial agreements and bioequivalence studies for new drugs and conventional products, and ensured that the trials/studies and protocols were in accordance with Good Regulatory Practices and Good Clinical Practices.
Assisted life sciences and chemical companies to draft a variety of complex patents involving the manufacturing process for creating polymers from waste gas and patents related to biological vaccines, among others.
Audited leading pharmaceutical companies to ensure that their product registration dossiers and advertising campaigns comply with Thai legislation.
Registered new biological product dossiers at the Thai FDA and received approvals within 1.5 years—a relatively short period of time to obtain approval for a new drug in Thailand.
Registered medical devices, food products, and cosmetics with the Thai FDA for domestic and international companies.
Worked with the firm’s litigation team and won a disputed patent litigation case for a chemical glass company, in which the opposing party claimed damages exceeding THB 50 million.

ABOUT Atthachai

Languages

Thai

English

Education

PhD, Mahidol University

BSc, Chulalongkorn University

LLB, Ramkhamhaeng University

Insights

November 18, 2024

Thailand Reaffirms Alcoholic Beverage Packaging and Labeling Requirements

A new notification on required labeling and packaging for alcoholic beverages was published in Thailand’s Government Gazette on November 8, 2024, taking full effect the following day. The notification (Notification of the Alcoholic Beverage Control Committee Re: Criteria, Methods, and Conditions for Packaging of Alcoholic Beverages and Warning Statements of Alcoholic Beverages Both Produced Domestically and Imported into Thailand 2024) essentially reaffirms a mandatory requirement for packaging and warning statements for alcoholic beverages, which echoes existing regulations from 2009 and 2017. Under the authority of the Alcoholic Beverage Control Act B.E. 2551 (2008) (ABCA), the notification reinforces the Alcoholic Beverage Control Committee’s objective of promoting consumer awareness through standardized warning labels. The notification addresses the following key aspects: Packaging definitions. The notification defines packing-related terms for the first time under the ABCA. These terms include (1) packaging, (2) containers (also known as primary packaging), and (3) outer packaging (secondary packaging). Packaging requirements. Containers for alcoholic beverages produced or imported for sale in Thailand must be at least 0.175 liters each. Warning statements. Although alcoholic beverages are classified as food under the Food Act B.E. 2522 (1979), the notification exempts alcoholic beverages from general food labeling requirements prescribed in the Food Act. Instead, it mandates that the following warning statements be prominently displayed: Sale of liquor to persons under 20 years old is prohibited; Drinking reduces driving ability; and Not suitable for persons under 20 years old. Format. The notification specifies that these warning statements must be written in Thai, in bold characters, with a minimum type size of five millimeters. The warning must be enclosed in a box that contrasts with the label background and surrounding content. Exemptions. Certain products, such as alcoholic beverages imported as samples or otherwise not intended for commercial sale, are exempt from the warning

August 8, 2024

ICLG: Pharmaceutical Advertising 2024—Thailand Chapter

Tilleke & Gibbins has contributed the Thailand chapter to the 2024 edition of Pharmaceutical Advertising from the International Comparative Legal Guides (ICLG) series published by Global Legal Group. This detailed guide offers an in-depth examination of pharmaceutical advertising laws and regulations in multiple jurisdictions around the globe. Each chapter of the guide, structured in a Q&A format, is organized into comprehensive sections covering various aspects of pharmaceutical advertising, including: General rules and codes of practice governing pharmaceutical advertising Required arrangements for ensuring compliance with advertising regulations Procedures for obtaining advertising approvals from regulatory authorities Penalties for non-compliance with advertising rules Guidelines for providing information prior to product authorization Requirements for advertisements directed at healthcare professionals Restrictions on the content of pharmaceutical advertisements The complete Thailand chapter is available as a PDF below. The Thailand chapter—and the full Pharmaceutical Advertising guide—are also freely available on the ICLG website.

June 24, 2024

Thailand Regulatory Change Paves Way for Psilocybin and Opiate Clinical Trials

Thailand’s Minister of Public Health recently promulgated the Ministerial Notification Re: Category 5 Narcotics Which Are Not Cannabis or Hemp Extract and Whose Consumption is Permitted for Treatment of Disease or for Research Purposes (2024). The notification took effect on April 23, 2024. The substances whose regulatory controls are affected by this new notification are psilocybin mushroom (Psilocybe cubensis (Earle) Singer), opium poppy (Papaver somniferum L. and Papaver bracteatum Lindl.), and other plants in these genera from which opium, opium alkaloids, psilocybin, or psilocin may be derived. As a result of this notification, these substances are now classified as category 5 narcotics that can be applied in medical treatment. Without the implementation of this notification, patients could not access newly developed medicines containing these substances, as Thailand’s Narcotic Code prohibits the possession and use of category 5 narcotics. Nonetheless, this does not mean that psilocybin mushrooms and opium can be used without any conditions. There is still a long process to go through before these substances can be used in medical treatment or clinical studies. Under the new notification, the FDA must first approve any medicinal drug formulation containing any of the above substances, and subsequently, the production must be approved for medical use or research purposes. The importation of medicinal drug formulations containing psilocybin mushrooms or opium is not allowed. This seemingly small regulatory change addresses the previous legal obstacle to the research and development of such medicines. According to the previous regulation, a physician or researcher could apply to the Thai FDA for a license to produce or possess medicines containing the aforementioned narcotics. However, production and consumption are considered different activities, and consuming a narcotic-containing medicine, even if it was produced under a valid license, is prohibited by the Narcotics Code and is punishable by imprisonment,

February 14, 2024

New Rules on Drug Importation for Clinical Trials Set to Take Effect in Thailand

Thailand is preparing to implement new rules on drug importation for clinical studies. The Medicines Regulation Department of Thailand’s Food and Drug Administration (Thai FDA) first issued the Notification Re. Detailed Requirements for Drug Importation into Thailand for Clinical Studies almost a year ago, and the notification is expected to come into effect on March 1, 2024. Key Provisions The notification aims at enhancing the efficiency of conducting clinical studies while ensuring the protection of human subjects participating in such studies within Thailand. Some of its key provisions include: Definition of Clinical Study. The notification defines a “clinical study” as a study of a medicine involving human subjects, conducted to provide supporting evidence for the registration of a medicinal product in Thailand or other countries, including for additional indications or variations of a registration dossier. Compliance with ICH GCP. Clinical studies conducted in Thailand must adhere to the current edition of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines. Clinical Trial Application. Sponsors are required to submit a clinical trial application along with supporting documents to the Thai FDA for approval before commencing a clinical study. The permit remains valid for five years and is renewable. Supply of Investigational Drugs. Sponsors must obtain investigational drugs from manufacturers compliant with Good Manufacturing Practice (GMP) standards as recognized by the Thai FDA. Postapproval Obligations. The secretary-general of the Thai FDA may impose postapproval conditions or order investigators to conduct or suspend certain activities to ensure human subject protection and regulatory compliance. Regulatory Oversight. The Thai FDA is responsible for inspecting and overseeing the regulatory compliance of clinical studies, including during prestudy, ongoing, and poststudy phases. The Thai FDA may also conduct inspections of clinical studies conducted overseas. The Thai FDA

Awards & Rankings

October 22, 2024

Tilleke & Gibbins Honored at IAM/WTR Global IP Awards 2024

Tilleke & Gibbins was named the winner in two categories at the Global IP Awards 2024, held on October 17 in London: Cambodia IP Firm of the Year Thailand Trademark Firm of the Year The Global IP Awards, launched in 2019, are compiled based on extensive research done by Intellectual Asset Management (IAM) and the World Trademark Review (WTR) for their annual IAM Patent 1000 and WTR 1000 rankings, and recognize the world’s best intellectual property law firms in more than 70 countries and jurisdictions. The organizers note that “The winners are selected on the basis of a wide range of criteria relating to excellence, achievement, and market reputation, and serve as a testament to the outstanding work being undertaken by IP firms across the globe.” For more details on the awards, and to view a full list of this year’s winners, please visit the Global IP Awards 2024 website.

September 30, 2024

Tilleke & Gibbins Receives Top Honors at 2024 Managing IP and Asialaw Awards

At the joint Managing IP and Asialaw Awards on September 27, 2024, Tilleke & Gibbins was recognized with two significant firm-level honors. The firm was named Thailand Firm of the Year for the 13th time and Vietnam Firm of the Year for the 11th time. The awards, held at the JW Marriott Hotel in Kuala Lumpur, Malaysia, celebrated firms and individuals who have demonstrated exceptional legal expertise and client service across Asia. Tilleke & Gibbins’ continued recognition in both Thailand and Vietnam reflects the firm’s consistent ability to deliver quality legal services and its leadership in the intellectual property and commercial sectors. In addition to these firm awards, Charunun Sathitsuksomboon, partner in the Bangkok office, received the Thailand Female Lawyer of the Year award, acknowledging her significant contributions to the legal profession and her outstanding client work over the past year. More information on the winners of the Managing IP Asia-Pacific Awards can be found here, and a complete list of Asialaw Awards 2024 winners and nominees is available here.

September 13, 2024

Tilleke & Gibbins Retains Strong Rankings in IFLR1000 Asia-Pacific 2024

The 2024 edition of the IFLR1000 Asia-Pacific rankings, released by International Financial Law Review (IFLR), highlights Tilleke & Gibbins’ continued excellence in financial and corporate transactional work. The firm has retained its strong rankings across multiple jurisdictions and practice areas, reaffirming its position as a leading firm in the Asia-Pacific region. This year, Tilleke & Gibbins received firmwide rankings in key jurisdictions, including: Thailand Banking & Finance – Tier 3 Capital Markets: Debt – Tier 3 Capital Markets: Equity – Tier 3 M&A – Tier 2 Project Development – Tier 2 Restructuring & Insolvency – Tier 3 Vietnam Banking & Finance – Other Notable M&A – Tier 3 Project Development – Tier 3 Cambodia Financial & Corporate – Tier 2 Project Development – Tier 2 Laos Financial & Corporate – Tier 2 In addition to these firmwide rankings, Tilleke & Gibbins had several standout individual recognitions, with 10 lawyers honored in the 2024 individual rankings, including new entries for John Frangos, Niti Muangkote, Santhapat Periera, and Tram Ngoc Bich Nguyen. The full list is as follows: Charunun Sathitsuksomboon – Highly Regarded, M&A, Thailand Charuwan Charoonchitsathian – Rising Star, M&A, Thailand David Mol – Rising Star, Corporate and M&A, Cambodia Jay Cohen – Highly Regarded, Banking, Cambodia John Frangos – Notable Practitioner, Restructuring & Insolvency, Thailand (new ranking) Niti Muangkote – Rising Star, Financial & Corporate, Laos; Highly Regarded, Banking & Finance, Thailand (new ranking) Saithong Rattana – Notable Practitioner, Project Development and M&A, Laos Santhapat Periera – Highly Regarded, Banking, M&A, Laos; Highly Regarded, Banking & Finance, Thailand (new ranking) Supasit Boonsanong – Highly Regarded, Project Development, Thailand Tram Ngoc Bich Nguyen – Highly Regarded, M&A, Vietnam (new ranking) To see the full set of IFLR1000 rankings for Tilleke & Gibbins’ jurisdictions, please see the Cambodia, Laos, Thailand, and

September 12, 2024

Tilleke & Gibbins Recognized in Asialaw 2024 Rankings

Tilleke & Gibbins has once again secured impressive rankings in the recently released Asialaw 2024 rankings. The firm has maintained its position as a top legal service provider across multiple jurisdictions, earning a total of 39 rankings in practice and industry groups, 19 of which are in the highest tiers. The firm’s performance continues to reflect its exceptional client service and legal expertise across Southeast Asia. Tilleke & Gibbins is recognized in all available categories for Cambodia, Laos, and Thailand, demonstrating the firm’s strong presence across the region. In the individual rankings, 22 of the firm’s practitioners have been recognized, including three notable promotions and three new entries: Charunun Sathitsuksomboon (Thailand), newly ranked as a Notable Practitioner for Corporate and M&A. Linh Thi Mai Nguyen (Vietnam), promoted to Distinguished Practitioner for Intellectual Property. Loc Xuan Le (Vietnam), promoted to Elite Practitioner for Intellectual Property. Niti Muangkote (Laos), a new entry as a Rising Star for Banking and Finance. Prisna Sungwanna (Laos), newly ranked as a Distinguished Practitioner for Corporate and M&A and Banking & Finance. Suebsiri Taweepon (Thailand), promoted to Distinguished Practitioner for Intellectual Property and Technology and Telecommunications. Client feedback remains a key component of the Asialaw rankings, with Tilleke & Gibbins earning high praise for its responsiveness and commercial awareness. The firm’s sector-specific knowledge also continues to stand out, with clients expressing their appreciation of the firm’s understanding of their businesses’ operational contexts. For more details and to browse the full rankings, please visit the Asialaw website.

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