| Chapter title |
Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea
|
|---|---|
| Chapter number | 9 |
| Book title |
Regulatory Aspects of Gene Therapy and Cell Therapy Products
|
| Published in |
Advances in experimental medicine and biology, January 2015
|
| DOI | 10.1007/978-3-319-18618-4_9 |
| Pubmed ID | |
| Book ISBNs |
978-3-31-918617-7, 978-3-31-918618-4
|
| Authors |
Minjoung Choi, Euiri Han, Sunmi Lee, Taegyun Kim, Won Shin, Choi, Minjoung, Han, Euiri, Lee, Sunmi, Kim, Taegyun, Shin, Won |
| Abstract |
The Ministry of Food and Drug Safety regulates gene therapy and cell therapy products as biological products under the authority of the Pharmaceutical Affairs Act. As with other medicinal products, gene therapy and cell therapy products are subject to approval for use in clinical trials and for a subsequent marketing authorization and to post-market surveillance. Research and development of gene therapy and cell therapy products have been progressing rapidly in Korea with extensive investment, offering great potential for the treatment of various serious diseases. To facilitate development of safe and effective products and provide more opportunities to patients suffering from severe diseases, several regulatory programs, such as the use of investigational products for emergency situations, fast-track approval, prereview of application packages, and intensive regulatory consultation, can be applied to these products. The regulatory approach for these innovative products is case by case and founded on science-based review that is flexible and balances the risks and benefits. |
Mendeley readers
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 25 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 5 | 20% |
| Student > Ph. D. Student | 4 | 16% |
| Student > Doctoral Student | 3 | 12% |
| Researcher | 2 | 8% |
| Other | 1 | 4% |
| Other | 4 | 16% |
| Unknown | 6 | 24% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 7 | 28% |
| Biochemistry, Genetics and Molecular Biology | 5 | 20% |
| Engineering | 2 | 8% |
| Agricultural and Biological Sciences | 2 | 8% |
| Business, Management and Accounting | 1 | 4% |
| Other | 2 | 8% |
| Unknown | 6 | 24% |