China Medicinal Biotech Association Formally Declares Stem Cell Quality Control Regulations

[Beauty Team] China Medicinal Biotech Association (CMBA) formally declared ‘Regulations on Stem Cell Manufacturing Methods and Quality Control’ (hereinafter called ‘the quality control regulations’) on October 25.

This declaration, which was supervised by ‘Zhejiang Gold Era Biotech Limited Company’ and ‘Hangzhou Biological Science Limited Company’, was conducted with many experts attending including those from Chinese Academy of Science, Academy of Military Medical Sciences, and Chinese Medical Association.

Stem cell technologies have been the key study area for international medicine for the recent several years. Therefore, China has declared the quality control regulations by focusing on the treatment and study using stem cells in order to achieve innovation of the related technologies. The declaration of the quality control regulations aims to clarify the quality standards, which have not been unified in the stem cell manufacturing area, and to develop the country’s medical technologies.

CMBA has prepared the basics for the quality control regulations such as ‘management methods for studies on stem cell treatment’, ‘control of mass of stem cell preparations,’ and ‘principles in instructions for study before treatment’ based on the Good Manufacturing Practice (GMP) since April 2015. After that, the present quality control regulations are established through several times of modifications.

The quality control regulations are composed of seven chapters and 83 articles. Chapter 1 covers the objective and grounds for establishing the regulations and the scope of application; Chapter 2 the systems and strategies for mass control needed in the manufacturing process of stem cell; Chapter 3 the suppliers and collection; Chapter 4 the reception and manufacturing method; Chapter 5 the passage and permission for manufacturing stem cells; Chapter 6 the transport and supplementary legal suits; and Chapter 7 the compliance of the manufacturers with the regulations, activity, interpretation of terminology, rights related to the regulations, and the date of enforcement.

The quality control regulations are documents on manufacturing of stem cells and quality control of stem cells. They aim to set the basic principles in manufacturing stem cells and to help manufacture proper stem cells that meet the usage. In addition, they have major significance for providing the grounds for assessing the abilities for manufacturing the cells and letting the related researches be done smoothly.

Meanwhile, Tongluxian Minister Fang Yi, who attended the declaration event, expressed his warm welcome to the experts and distinguished guests who participated in the meeting and said congratulations to the establishment of the CMBA Standard Business Commission and the enforcement of the quality control regulations. He said that currently Tongluxian was operating a number of health service businesses and that of those, the health business related to stem cells already began its overall implementation. He showed his confidence in that the declaration of the quality control regulations would make a new epoch in basic researches on stem cells, development of researches for technological application, industrialization, and the latest medical researches.

After the declaration event, the CMBA Standard Business Commission held its first meeting to have a discussion on the autonomous regulations on quality control of cell aggregations. The Commission estimated that the declaration of the quality control regulations would have a positive impact on the health, stability, and rapid development of the biological therapy industry of China. (photo by Hangzhou Biological Science Limited Company)


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Write: 2016-11-09 18:04:55 / Update: 2016-11-09 18:52:28

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