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Revised Drug Registration Regulation Brings New Challenges and Opportunities to New Drug Clinical Trials in China
Jianqing Chang
Tigermed Co., Ltd.

n March 30, after six rounds of seeking public comments over the last several years, the State Administration for Marketing Regulation (SAMR) issued the revised Drug Registration Regulation (DRR), which will be put into effect on July 1, 2020. This is not only the first revision since the current version implemented thirteen years ago, but also a revision with significant changes to support enforcement of the 2nd revision of Drug Administration Law and the newly enacted Vaccine Administration Law, both of which became effective on December 1, 2019.

The DRR was formulated by the National Medical Products Administration (NMPA), an agency within the SAMR. In the process of revising the DRR, the NMPA took into consideration the urgency of the unmet medical needs, industry development and input, best regulatory practices, and the remarkable achievements of the regulatory reform launched in 2015 such as the drug MAH (Marketing Authorization Holder) system pilot and the clinical trial approval process, among others.

The revised DRR also consolidates many of the processes and requirements developed in the regulatory reform. For example, in the revised DRR, a new chapter is devoted to expedited pathways: breakthrough therapy designation, conditional approval, priority review and approval, and special approval. The scope of applicability, procedures, supportive policies, and other requirements for each of the pathways are specified. Urgently needed drugs, pediatric drugs, orphan drugs, drugs for major infectious diseases, vaccines urgently needed for disease prevention and control, and innovative vaccines are eligible for expedited approval.

Highlights of DRR Changes Related to Clinical Trials

The Applicant shall:

  • Apply for approval of the first clinical trial.
  • File the protocols of the subsequent clinical trials.
  • File a Development Safety Update Report (DSUR) once a year after approval of the clinical trial application.
  • File Annual DSUR for minor variations or submit supplementary applications for major variations during the clinical trial.
  • For additional indication(s) of a drug with approved clinical trial(s), Applicant shall file a new clinical trial application (CTA).
The Sponsor shall:

  • Upload the trial protocol and other required information to the China Drug Trials Registration and Information Publication Platform before the trial begins.
  • Modify the protocol, suspend or terminate the clinical trial as needed, and report to the Center for Drug Evaluation (CDE) if safety issues or other risks are identified during a clinical trial, in a timely fashion
  • Start the clinical trial within three years of CTA approval.
The Agency will initiate risk-based inspections, risk-based extended inspections, for-cause inspections, and routine administrative inspections. In case of dispute, a resolution should be reached before completion of the review.

New Opportunities and Challenges for Clinical Trials in China

The 60 working day timeframe for CTA approval is the most remarkable and encouraging process designed to enable China in joining global clinical trials. The further improvement of communications between the Applicant and CDE as well as the expert consultation system will be of great importance in facilitating an effective CTA process. In the future, a predictable approval timeframe will be made possible by the introduction of risk-based site inspections and the provision that registration lab testing can be conducted in parallel with the technical review. The breakthrough therapy designation provision and the conditional approval procedure during the clinical trial stage, and the priority review during the NDA stage, will expedite drug registration and reduce the drug lag.

Encouragingly, the revision of DRR has optimized the overall review and approval framework, systems, principles, and procedures. It becomes another important milestone for the fast growth of the R&D-based pharmaceutical industry and to further satisfy unmet medical needs in China.

More than 50 supporting documents or technical guidelines are being drafted to support implementation of the revised DRR in the coming months.