CFDA’s “Orange Book” launch marks new era of quality generics

Standards for generic products will ensure quality throughout the Chinese market

The China Food and Drug Administration (CFDA) marked the turn of the year with the formal release of a first iteration of the "Listed Drugs Catalogue of China”, in other words a Chinese version of the U.S. FDA’s “Orange Book”. The Catalogue is expected to provide a full record of all newly listed drugs, including details such as API, dosage form, specification, marketing license holders, and patent information, alongside details of all generic drug products that have been approved as matching the original in terms of quality and bioequivalence. The CFDA is starting slowly, the first iteration including 131 drug varieties and 203 individual drug specifications. The list includes 13 generic drugs in 17 specifications that have met China’s recently introduced quality and efficacy equivalency standards compared with originator reference products. A total of 39 multinational pharmaceutical companies have products on the list, Pfizer leading with 28 drug listings.

The Chinese version of the Orange Book is a key part of the CFDA’s overarching drug approval system reforms, and will support the development of a patent linkage system. Directly modelled on the U.S. example, the aim is to establish Hatch-Waxman-style underpinnings that will both encourage innovative drug development while rewarding generic manufacturers producing high-quality products. The plans for patent linkage and a Chinese Orange Book were first broached in the CFDA’s Circular No. 55, released in May 2017.

Source: GBI (

Copyright Widler & Schiemann AG 2015. All Rights Reserved. /