|
KMID : 1142220120070010091
|
|
Regulatory Research on Food, Drug & Cosmetic
2012 Volume.7 No. 1 p.91 ~ p.102
|
|
|
The Registry of Biopharmaceutical Drugs in the Korean Official Conpendium
|
|
Nam Doo-Hyun
Hwang Jae-Yoon
Cho Myung-Hwan
Kim Hong-Jin
|
|
|
Abstract
|
|
|
The biopharmaceutical drugs which are produced by recombinant DNA technology or new biotechnology and used for the treatment of human diseases have developed since 1980s, and successfully introduced in drug market. Some of them became blockbuster drugs and have entered in the category of major drugs having a grand market size. In this study, the registry of the biopharmaceutical drugs in official compendium including Korean Pharmacopoeia was investigated by comparing foreign pharmacopoeias such as US Pharmacopoeia, European Pharmacopoeia and Japanese Pharmacopoeia. In Korea, biologic drugs have been regulated by the official notification「The Criteria and Test of Biologics」, and the recombinant pharmaceuticals has been also regulated in this notification. However, the market expansion of drugs in this category requires the official registry in the official compendium. In this article, the necessity of registration of some selected biopharmaceuticals in the official compendium is addressed, and the consideration points in general notices, general rules of preparations, general tests and general information of Korean Pharmacopoeia is suggested. In addition, the registration of biosimilar drugs in official compendium, for example in Korean Pharmaceutical Codex, is also proposed, for taking action on the market entrance of biosimilar drugs following the expiration of patent of oldest
biopharmaceutical drugs. This will be helpful in more effective management and regulation of biopharmaceutical drugs and in harmonization with international requirements.
|
|
|
KEYWORD
|
|
|
biopharmaceutical drugs, recombinant pharmaceutical drugs, Korean Pharmacopoeia, registry proposal, quality criteria, test method
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|