| Chapter title |
Regulatory Frameworks for Gene and Cell Therapies in Japan
|
|---|---|
| Chapter number | 8 |
| 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_8 |
| Pubmed ID | |
| Book ISBNs |
978-3-31-918617-7, 978-3-31-918618-4
|
| Authors |
Daisuke Maeda, Teruhide Yamaguchi, Takami Ishizuka, Masakazu Hirata, Kazuhiro Takekita, Daisaku Sato, Maeda, Daisuke, Yamaguchi, Teruhide, Ishizuka, Takami, Hirata, Masakazu, Takekita, Kazuhiro, Sato, Daisaku |
| Abstract |
The regulations for the human use of advanced therapy medical products such as gene and cell therapy products have evolved in accordance with advance of clinical experience, scientific knowledge, and social acceptance to these technologies. In Japan, two laws, the Pharmaceuticals and Medical Devices (PMD) Act and the Act on the Safety of Regenerative Medicine (ASRM), were enacted in November 2014. The PMD Act defines regenerative medical products for the first time and introduces a system for the conditional and time-limited marketing authorization of regenerative medical products. Under ASRM, the responsibilities of medical institutions to ensure the safety and provide transparency of such medical technologies are described. Amendments to accompanying guidelines for these two Acts are currently in preparation. It is expected that the new legislative frameworks will promote the timely development of new products and technologies, to bring safe and effective regenerative medicines to Japanese patients. |
X Demographics
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 2 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Scientists | 1 | 50% |
| Members of the public | 1 | 50% |
Mendeley readers
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 28 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Ph. D. Student | 7 | 25% |
| Student > Doctoral Student | 4 | 14% |
| Student > Master | 4 | 14% |
| Student > Bachelor | 1 | 4% |
| Researcher | 1 | 4% |
| Other | 1 | 4% |
| Unknown | 10 | 36% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 4 | 14% |
| Pharmacology, Toxicology and Pharmaceutical Science | 3 | 11% |
| Agricultural and Biological Sciences | 3 | 11% |
| Biochemistry, Genetics and Molecular Biology | 2 | 7% |
| Social Sciences | 2 | 7% |
| Other | 4 | 14% |
| Unknown | 10 | 36% |