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Thai FDA and Stem Cell Regulations in Thailand

Thai FDA and Stem Cell Regulations in Thailand: An Overview

Cellular Therapy and Stem Cell research and therapy are subject to strict regulations in Thailand to ensure safety, efficacy, and ethical standards. The Thai Food and Drug Administration ( Thai FDA) plays a central role in regulating stem cell therapies as biological products[1][5]. Here’s a summary of the regulatory landscape:

Key Regulatory Aspects

• FDA Oversight: The Thai FDA has established guidelines for the use of Cellular Therapy and Stem Cells in medical treatments[1]. These guidelines ensure that stem cell therapies meet the required ethical and safety standards[5].
• Ethical Guidelines: Thailand has implemented ethical guidelines for Cellular Therapy and Stem Cell research and therapy, which researchers must follow to conduct their work[1].
• Advanced Therapy Medicinal Products (ATMP): The FDA has issued announcements on the registration of Advanced Therapy Medical Products (ATMP) to control, monitor, and consider their registration in Thailand[2]. Cellular Therapy and Stem Cells products must pass certification in pharmaceutical, immunological, or metabolic procedures to ensure they are safe for therapeutic use[2].
• GMP Standards: Good Manufacturing Practice (GMP) is a crucial standard, indicating that a product or medicine has passed strict quality control and can be traced back to ensure safe use[2]. SCL laboratory is the only company in Thailand that has been legally licensed and has been certified ISO 9001: 2015 stem cell manufacturing, as well as adopting the world-class international standard in identifying each type of cell to be coded (ISBT 128 standards), complying with the Good Manufacturing Practice (GMP), Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co- Operation Scheme (PIC/S), and Standard Operating Procedure (SOP)[2].
• Allogeneic Stem Cell Donation Service: The National Blood Center is implementing a system following the World Marrow Donor Association (WMDA) standard for allogeneic stem cell donation services[2].
• Research and Clinical Trials: Thailand has been forward-thinking in permitting regenerative medicine clinical trials and therapies, which accelerates the creation and accessibility of state-of-the-art medical care[5].
• Regulatory Body: At the moment, Cellular Therapy and Stem Cell medicinal products have not been registered in Thailand. Thus, Thai FDA is the main institution in oversight the health products with supports from the Department of Medical Sciences and they should be equipped with knowledge, laboratory capabilities, and manpower for cell therapy medicinal products to be registered in Thailand[3].
• Medical Council Regulations: The Medical Council (MC) drafts stricter regulations explicitly covering all stem cell research and practice conducted by medical doctors, requiring scientific and ethical approval for any Cellular Therapy and Stem Cell Research and Clinical Trials[4].

DrStemCellsThailand‘s Anti-Aging and Regenerative Medicine Center of Thailand and Regulatory Compliance

At DrStemCellsThailand‘s Anti-Aging and Regenerative Medicine Center of Thailand, we adhere to all regulatory standards set by the Thai FDA and other relevant bodies. Our commitment includes:

• Ethical Practices: Ensuring all Cellular Therapy and Stem Cells are conducted ethically and safely, in compliance with Thai FDA guidelines[1][5].
• Quality Manufacturing: Partnering with GMP-certified laboratories like SCL to ensure the Cellular Therapy and Stem Cells used in our treatments meet the highest quality and safety standards[2].
• Rigorous Evaluation: Conducting thorough evaluations to determine patient suitability for Cellular Therapy and Stem Cells, in line with regulatory requirements[2][3].
• Collaboration: Working closely with regulatory bodies and experts to advance the field of regenerative medicine in Thailand responsibly.

Consult with Our Team of Experts Now!

References

1. Stem cell regulations. Vegas Stem Cell. https://vegastemcell.com/stem-cell-regulations/
2. Frequently Asked Questions About Stem Cells. Stemcellforlife. https://www.stemcellforlife.co.th/en/faq/
3. THE CASE OF CELL THERAPY MEDICINAL PRODUCTS … ThaiJo. https://li01.tci-thaijo.org/index.php/TBPS/article/view/252769
4. Advanced health biotechnologies in Thailand: redefining policy … PMC. https://pmc.ncbi.nlm.nih.gov/articles/PMC3564822/
5. Thailand’s stem cell advantages. Vegas Stem Cell. https://vegastemcell.com/articles/thailands-stem-cell-advantages/
6. GMP on Advanced Therapy Medicinal Product in Thailand. Thai FDA. http://planfda.fda.moph.go.th/meeting/agenda_att/file_emeeting_agenda_att__998_179_20180425_1537224043.pdf
7. Advanced therapies in Thailand – HITAP. HITAP. https://www.hitap.net/wp-content/uploads/2016/02/Proposal_advancedhealthbiotechnologies_final.pdf
8. Top Regenerative Medicine Stem Cell Clinics in Thailand. Stem Cell Council. https://www.stemcellcouncil.com/article/top-regenerative-medicine-stem-cell-clinics-in-thailand-your-ultimate-guide-for-2023