Dept sets new cell bank rules

The Department of Medical Sciences (DMSC) has unveiled new regulations for cell banks, aiming to boost biomedical research standards and support the health economy.

Dr Sarawut Boonsuk, director-general of the DMSC, said on Sunday the regulation, set to take effect in early November, will establish certification standards for cell banks, aligning Thailand with international best practices.

The move is expected to enhance safety, quality, and innovation in cell-based research and therapies.

Cell banks store human cells under controlled conditions for future use in medical treatments, research, and product development.

With rapid advancements in cell preservation and utilisation technologies, Dr Sarawut emphasised the need for a robust regulatory framework to ensure trust and safety.

The certification system covers key areas including personnel qualifications, facility standards, equipment, storage protocols, and quality management systems. A manual has been issued to guide both public and private sector operators.

The standards apply to the storage of human cells for research and the development of Advanced Therapy Medicinal Products (ATMPs), which include cutting-edge treatments such as gene and cell therapies.

The regulation was published in the Royal Gazette on Oct 9 and will come into force 30 days later.

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