Law and Regulation

Administration measures of different countries

Law and Regulation are the vital factors of our product – MSCs preparation. During the research of clinical trials, we found that several scientist teams have finished clinical trials in China. As we all know that there have existed about 10 MSCs drugs in the world by now, but none of them is approved in China, which confused us that why there is no MSCs product approved in China. We investigated the administration measures of different countries and compared them with that of China, and asked legislation experts some questions during the meeting, hoping to know how far our project would go and find a proper way for development of MSCs therapy in China.


1. America
Laws
- Current Good Tissue Practice (cGTP)
- Current Good Manufacture Practice (cGMP)
Sort management by the risk of cell/tissue products

2. European Medicines Agency (EMA)
Laws
- Standards of Quality and Safety for the Donation, Procurement, Testing, Processing, Reservation, Storage and Distribution of Human Tissue and Cells
- Regulation of Advanced Therapy Medicinal Products
EMA focus on the common characteristic of Advanced Therapy Medicinal Products:
- Complex and high creative process
- Special producing process
- Rare experts can assess it
- Can trace back to the donator
- Still high risk after approval
- Need long-term observation
- Middle or small institution can carry out
- Belong to fast creative field

3. Australia
Laws
- In 2002, the Meeting of Ministers of Health agreed Therapeutic Goods Administration (TGA) to enact guideline of cell and tissue therapy

4. Korea
Laws
- In 2011，Good Manufacture Practice was carried out
Cell therapy products administrated by Ministry of Food and Drug Safety


5. Japan
Laws
- Guidelines on Ensuring the Quality and Safety of Products Derived from Processed Cell/Tissue
Two pathways for development of cell therapy


6. China
Technic or Medicine?



What happened in 2012?
- Stem cell black market: As we all know that clinical trials are forbidden to charge the patients, but a few hospitals over-advertised the effect of stem cell therapy and even charged the patients, which causing severe effect to the society.

The Death of Wei Zexi
- Wei Zexi was a 21-year old Chinese college student from Shaanxi who died after receiving experimental immunization therapy treatment for synovial sarcoma at the Second Hospital of the Beijing Armed Police Corps. One of the serious influences of his death is the halt of all stem cell clinical research over China.


Reference：
http://www.fda.gov
http://www.ema.europa.eu/ema/
https://www.tga.gov.au
http://eng.kfda.go.kr/index.html
http://www.mhlw.go.jp/english/
http://www.nhfpc.gov.cn
http://www.sda.gov.cn

Different countries have different attitudes toward MSCs therapy

In the European Union, stem cell research using the human embryo is permitted in Sweden, Finland, Belgium, Greece, Britain, Denmark and the Netherlands; however, it is illegal in Germany, Austria, Ireland, Italy, and Portugal. The issue has similarly divided the United States, with several states enforcing a complete ban and others giving financial support. Elsewhere, Japan, India, Iran, Israel, South Korea, and Australia are supportive. However, New Zealand, most of Africa (except South Africa), and most of South America (except Brazil) are restrictive.

Reference:
https://en.wikipedia.org/wiki/Stem_cell_laws
http://www.explorestemcells.co.uk/stemcellresearcharoundworld.html

What’s More

We attended Guangdong Cell Therapy Annual Meeting and learn much more about MSCs legislation.
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