Following the release of the Opinions of the State Council on the Reform of Evaluation and Approval System for Drugs and Medical Devices (the “Reform”) issued by the State Council of the People’s Republic of China in August 2015, which aims to promote the reform of pharmaceutical registration regime to increase efficiency, recently, the China Food and Drug Administration (the “CFDA”) released the Administrative Measures for Drug Registration (Draft for Comments) (the “Draft”) which is open for public comment until 26 August 2016.  The Draft mainly improves the transparency and efficiency of the drug approval process in China.

The main amendments are summarised as follows:

  • Drug registration applications are split into clinical trial drug applications, drug marketing applications and their supplements as well as renewal applications after the drug has been released to market.
  • The Draft encourages drug innovation with respect for clinical values and offers prior approval for drugs that meet the corresponding requirements.
  • The Draft establishes a communication system between applicants and the approval organisations, with detailed procedures and requirements.
  • It is the first time that an expert advisory committee system has been clearly established. Suggestions made by this committee could be important references in the evaluation process.
  • A dispute resolution system is to be established. By taking into account the views of the expert advisory committee, a rehearing of the case and an administrative review, the authority can solve disputes with applicants during the review and approval process.
  • It will be required that the CFDA regularly releases information on the approval process, conclusion and relevant staff concerning the acceptance, examination, testing, review and approval of drugs.
  • It clearly mentions the establishment of the drug marketing approval system.
  • The patent linkage system is still not established.

Long drug approval periods have been a big problem for several years. The Draft introduces several communication processes, and dispute resolution and information publication regimes which may contribute to improving the efficiency of the approval process and reduce the corresponding approval period. However, the Draft is still open for public comment and the final version which will be implemented still remains to be seen.