원문정보
초록
영어
As biological technology is rapidly developing, the drugs which use the BT technology is also emerging. But these drug are difficult to be applied the classical evaluation method which used to evaluate of the safety and efficacy.
So many person says that regulatory process by NRA(National Regulatory Authority) is the bottleneck of the commercialization of the new bio-drugs. To break the bottleneck, KFDA has published the guideline for the evaluation in recombinant biological products since 2005.
In this presentation, first the status of guideline and how to make a guideline will be introduced. Secondly, the guideline about quality evaluation and how to get an information about guideline will be showed.
Ⅰ. The status of guideline about biologicals
Ⅱ. The Process of the making a guideline
Ⅲ. The guideline for evaluation of the quality in biologicals
1. Vaccines
2. Recombinant Products
3. Gene & Cell therapy
4. Others
Ⅳ. On-line information about guideline
Ⅵ. Conclusion