Chinese Orange Book regime is likely to be established

The China Food and Drug Administration (“CFDA”) held a meeting on 23 March 2017 to review the process of the reform of the drug registration regime (the “Reform”). The meeting summarised the achievements in 2016 and decided key tasks for the Reform in the coming year.

The key tasks for the Reform in 2017 are summarised below:

1. promote the Reform and further encourage innovation in drug development;
2. promote the consistent evaluation of the quality and efficacy of drugs;
3. require registration of the drug production process and establish a record system for different drug varieties;
4. change the drug registration application acceptance system and apply an electronic common technical document (eCTD);
5. perfect the evaluation process and enhance the efficiency of such process;
6. refer to the ‘Orange Book regime’ of other advanced countries and establish a corresponding regime in China;
7. strengthen the management of clinical trial institutions and ensure more clinical resources for the consistent evaluation of generic drugs; and
8. further promote the pilot program of the drug marketing authorisation holder system.

The potential ‘Orange Book regime’ in China has attracted significant attention both domestically and overseas. Currently, the Chinese drug registration regime is not highly connected with the patent protection regime. The CFDA adopts limited responsibility in protecting the original drug’s patents during the drug registration process, which leads to many drug infringement disputes. Establishing an ‘Orange Book regime’ in China would enable stronger protection of the patents of the original drugs which are mostly owned by multi-national pharmaceutical companies.