Dr. Veerapol Khemarangsan, Chief Executive Officer of MEDEZE Group Public Company Limited (MEDEZE), stated that the company fully complies with the Cell Banking certification standards in alignment with the Royal Gazette announcement prescribing the criteria and conditions for the certification of Cell Banking standards issued by the Department of Medical Sciences (DMSC). The certification follows the regulation officially published in the Royal Gazette on October 9, 2025, which will come into effect 30 days after publication.
According to the Royal Gazette, the Department of Medical Sciences has announced the Regulation on the Criteria and Conditions for Cell Banking Standard Certification, B.E. 2568 (2025), which defines the framework for certifying “Cell Banks.” The regulation stipulates that each Certificate of Standard Compliance shall be valid for five years, and applications for renewal must be submitted no less than 120 days prior to expiration, among other detailed provisions.
Establishing standardized criteria for Cell Banking is regarded as a key mission of the Department in ensuring a robust, safe, and reliable supervisory system. The certification framework comprehensively covers personnel qualification assessment, facility and equipment requirements, as well as cell storage procedures and quality management systems, to ensure that certified entities operate according to scientific principles and international standards.
Additionally, the Department of Medical Sciences has developed a Cell Banking Standards Manual as a guideline for both public and private organizations. This manual encompasses the requirements for human cell collection and storage for research and the development of cell therapy products, including both minimally manipulated and advanced therapy products. It also specifies detailed requirements for qualified personnel, facilities, equipment, processes, and quality management systems, ensuring that these standards can be effectively and safely applied.
This regulation serves as an important mechanism in advancing Thailand’s modern healthcare and biotechnology industries, promoting the safe and lawful application of advanced biotechnologies, and ensuring maximum benefit to the nation’s public health system and its people.