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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 secretary-general may also order investigators to amend, suspend, or cancel a clinical study if deemed necessary.
  • Reporting Requirements. Sponsors must submit various reports, including adverse event reports and progress reports, as prescribed in subsequent notifications.

The detailed requirements outlined in the notification are a notable step forward for importation of drugs into Thailand for clinical studies. Sponsors and investigators involved in clinical studies within Thailand should familiarize themselves with these provisions to ensure full compliance.

For further guidance on complying with the notification, or on any aspect of pharmaceutical business operations in Thailand, please contact Tilleke & Gibbins at bangkok@tilleke.com.

WRITTEN BY

Tilleke & Gibbins
For further information, please contact:

Atthachai Homhuan – Director, Regulatory Affairs, Tilleke & Gibbins
atthachai.h@tilleke.com

Dr. Atthachai Homhuan is the director of the regulatory affairs department at Tilleke & Gibbins. Atthachai assists chemical, life sciences, pharmaceutical, and biotechnology companies with regard to the preparation and submission of the healthcare product dossiers for registration, including biological products and vaccines, biosimilar products, new chemical entities, medical devices, food and herbal products, cannabis and hemp, cosmetics, and household chemicals. He assists international companies in developing market entry strategies for countries in Southeast Asia. His broad experience allows him to evaluate the feasibility of product registrations, conduct pharmaceutical and medical device plant audits/due diligence, and coordinate pre-clinical and clinical trials in accordance with international guidelines and standards. Atthachai also reviews healthcare product labeling/claims/advertisements for food products, cosmetics, medical devices, cannabis and hemp, and drug products in Thailand and other Southeast Asian countries.

In addition, he also assists the life sciences industry 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 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.

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 South East Asian Drafting Training Course, enabling him to prepare patent applications and claims.

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.

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