Pharmaceutical News
MOHW may issue the first license to autologous cell therapy in December
2018/12/09

Reported by Yen Ya-Fang

Since the implementation of the “Regulations Governing the Use of Specific Medical Technology and Medical Equipment for Examination and Test”, the MOHW has received quite a few applications for “anti-cancer immune-cell-therapy products”.  The MOHW may issue the first license to such products in December.  Also, the Executive Yuan is likely to approve the draft of the Regenerative Medicine Act in the first half of next year.  The market investors are optimistic about the emerging biomedical technology, such as cell therapies, regenerative therapies, etc.

The government implemented the “Regulations Governing the Use of Specific Medical Technology and Medical Equipment for Examination and Test” in September as part of the measures for improving the investment environment for the biomedical industry.  The government’s efforts in promoting the biomedical industry has attracted the investors’ attention.

According to the results of a research conducted by Technavio, the global stem-cell therapy market will grow steadily from 2017 to 2021 at a compound annual growth rate of 36% due to the advances in stem-cell preservation technology, the increase of donors and the use of automated cell processing system.  The global market is estimated to be worth over US$100 billion.

Many biotech companies in Taiwan are already able to provide high quality cell production and perform cell storage technology.  In the future, they have the potential to expand into biomedical areas, such as autologous stem cell transplantation and allogeneic stem cell storage. 

The ITRI has been working on the researches of cell therapy and regenerative medicine.  The R&D results include a highly efficient serum-free medium for mesenchymal stem cells and a golden ratio that encourages cell growth. The ITRI expressed that advanced therapies, such as immune-cell therapies and gene therapies, will trigger a new wave of industrial reform.

 

【2018-12-05/ Economic Daily】