Technical Requirements for
Biopharmaceutics Classification
System–based Biowaiver in China
Title
Technical Requirements for
Biopharmaceutics Classification
System–based Biowaiver in China
Abstract
Since its inception in 1995, the Biopharmaceutics
Classification System (BCS) has become
an increasingly important tool for regulation
of drug product development worldwide.
The regulations with respect to biowaivers for
immediate-release solid oral dosage forms in
the United States, the EU, and from the World
Health Organization are summarized and compared
in this article. On this basis, technical
requirements for BCS-based biowaiver in China
are proposed, and biowaiver eligibility of
immediate-release oral products in the China
Pharmacopoeia 2005, and the top 200 best
sale list in 2008 are evaluated, which shows a
similar trend to those found in the top 200 lists
from the United States and Great Britain.