Chinese “Orange Book” – open for public comments

Following the publication of “Announcement on Relevant Matters concerning the Evaluation of Consistency of the Quality and Efficacy of Generic Drugs”, the Center for Drug Evaluation (“CDE”) of the China Food and Drug Administration issued the Catalogue of Marketed Drug in China (Draft for Comment) (the “Catalogue”) on 4 September 2017. The public may put forward opinions and suggestions before 15 September 2017.

The Catalogue consists of five parts, i.e. Preface, Users’ Guidance, Catalogue of Drugs, Appendix and Index.

1. Preface This part is a general introduction to the Catalogue. It sets out the background and the objectives of the Catalogue.
2. Users’ Guideline This part includes instructions on how to use the Catalogue, the drugs covered by the Catalogue and definitions of relevant terms. According to the Users' Guideline, the drugs below will be covered in the Catalogue: approved innovative drugs, improved drugs and imported original drugs;generic drugs registered under the new registration regime;drugs which passed the evaluation of consistency in terms of quality and efficacy; andother drugs identified by the CFDA.
3. Catalogue of Drugs This part lists the active ingredients, names, specifications, formulations, reference listed drugs, manufacturers and other basic information of the drugs. The current draft covers 19 drugs, including 12 imported original drugs, 2 innovative drugs and 5 generic drugs which were registered under the new registration regime.
4. Appendix The Appendix contains relevant patent and data protection information.
5. Index The Index guides users on how to retrieve information.

The Catalogue will be updated in real-time. Newly approved drugs will be included into the Catalogue immediately whereas drugs with safety risks or which have been withdrawn will be removed from the Catalogue. CFDA will update the online Catalogue (which is in the form of a database) on its official website and will release an electronic version of the Catalogue at the end of each year available for download.

Given the fact that the Catalogue is still in its early stage, the content and types of drugs covered are still very limited, the authority will gradually increase and develop the corresponding content to improve the Catalogue.

This Catalogue is analogous to the US’ Orange Book and will be the fundamental in establishing the Chinese patent linkage regime which is expected to bring additional protection for drug innovators.