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Product Regulation & Liability

Thailand: Urgent reminder – Drug product registration license renewal deadline fast approaching

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In brief

The deadline for renewing the drug product registration license is approaching. All renewals must be submitted by 12 October 2024.

In more detail

Manufacturers and importers who obtained drug product registration license approvals from the Food and Drug Administration (FDA) before 1 January 1997 (prior to the enforcement of the ASEAN harmonization requirement) must submit the documents in the ASEAN Common Technical Dossier (ACTD) format to obtain the approvals for the drug product registration license renewals by 12 October 2024. Key actions include ensuring that all necessary documents are updated in line with current regulations, submitting the renewal applications to the FDA by the deadline, and keeping a record of the approval status.

Failure to renew drug product registration licenses by 12 October 2024 may result in penalties and suspension of the drug product registration license.

For more information or assistance, please contact our Healthcare & Life Sciences and Regulatory Affairs Services team.

The following have contributed to this legal update:

  • Praween Chantanakomes, Head of Regulatory Affairs Department
  • Prim Uditananda, Regulatory Affairs Manager
  • Monsicha Boonsiri, Regulatory Affairs Officer
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Peerapan is a Corporate and M&A partner and heads the Sustainability Group and Healthcare & Life Sciences Industry Group in Bangkok. She also co-heads the Investigations, Compliance & Ethics Practice Group in Bangkok and is currently a member of the Firm's Global Executive Committee. Peerapan has nearly 40 years of experience advising on transactional and regulatory matters in highly regulated industries. Peerapan is exceptionally fluent in regulatory matters relating to healthcare, consumer protection and product liability.
Peerapan also has extensive experience advising on compliance issues, risks facing companies across various industry sectors, and regularly assists clients in practically managing and mitigating those risks. She has been consistently recognized as 'Leading Individual’ in Corporate M&A by the Asia Pacific Legal 500 for eight consecutive years (2013-2020) and has been inducted into the Asia Pacific Legal 500 Hall of Fame in Corporate M&A in 2020-2023. More recently she has been shortlisted for Corporate and M&A Lawyer of the Year by the Legal 500 Southeast Asia Awards. Peerapan was also awarded ‘Client Choice winner’ for Healthcare & Life Sciences 2019 by Lexology.
In October 2022, Peerapan was elected to join the Global Executive Committee and serve as chair of the Asia Pacific region. In this role, Peerapan works alongside the Firm's leadership to drive forward the Firm’s business strategy and prioritized actions.

Author

Panyavith assists major local and multinational clients in a range of heavily regulated industries, such as healthcare & life sciences, chemical and biotech, on large complex mergers and acquisitions, private equity transactions, joint ventures, corporate restructurings, post-acquisition integration projects, commercial agreements and regulatory issues. With his technical and commercial astute, Panyavith has often been involved in a number of pioneering projects, helping clients navigate the challenges of uncharted waters and emerging opportunities with innovative solutions. He is recently recognized as "Up and Coming for Corporate and M&A" in Thailand by Chambers Asia-Pacific 2023.

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