Clinical Research in Japan: ways to Alleviate Unnecessary Regulatory Burdens

• Autor(a) principal: Kawakami, Koji
• Data de Publicação: 2007
• Outros Autores: Yamane, Hiroko
• Tipo de documento: Artigo
• Idioma: por; eng
• Título da fonte: RECIIS (Online)
• Texto Completo: https://www.reciis.icict.fiocruz.br/index.php/reciis/article/view/880
• topic: Biotechnology; biologics; drug development; regulatory science; clinical trial; Biotecnologia; biológicos; desenvolvimento de medicamentos; ciência regulatória; teste clínico

For drug discovery and development today, synergy between pure science, clinical research, and the organization of clinical trials is essential. In Japan, there is a delay in the institutional response to this need. This paper identifies one of the bottlenecks in the Japanese regulatory process. Clinical research undertaken by university researchers and medical doctors are not integrated into the Japanese drug approval procedure. Therefore, their efforts and research data are wasted in the inherently unpredictable nature of long and costly biomedical research. Collaborative efforts between companies and researchers/medical doctors should be encouraged through institutional incentives, by integrating university and medical clinical research ab initio into regulatory process. In order to achieve this, it would be necessary to promote commercial exchange of database information and short-term employment of researchers in those projects leading to regulatory approval.