Regulatory reform in China enhancing clinical trials review and approval

In order to encourage innovation, speed up access to new drugs and meet the needs of patients, an updated investigational new drug (IND) review procedure was created in China and has been in effect for just over a year. The change drew discussion at both the DIA China 2019 meeting in Beijing in May as well as DIA 2019 in San Diego in June.


New IND review procedure

Relevant matters for the review and approval of drug clinical trials were adjusted as follows:

  • In the case of an application for a drug clinical trial in China, if the applicant has not received any rejection or query opinions from the Centre for Drug Evaluation (CDE) of the National Medical Products Administration within 60 days from the date of application acceptance and payment, the applicant may carry out the drug clinical trial according to the submitted protocol.
  • The applicant no longer needs to submit the application to the PFDA (provincial FDA) and the process became simpler. The applicant only needs three steps to carry out the IND: a pre-IND meeting, submission of the filing to the CDE, and the CDE’s review and approval.
  • The new IND review procedure marks China’s formal approval system change from an examination and approval system to tacit permission. It is expected that the approval time for regulatory approval of clinical trial applications will be shortened from 265 days to 65 days.
  • Xiaoyuan Chen, director of the Clinical Research Institution School of Medicine at Tsinghua University, was among those to comment on the progress of the new system in a presentation in San Diego. Chen report that as of June 21, 2019, 744 clinical trials applications had been approved under the new procedures with a mean review timeline of 40 workdays.The new IND review procedure marks China’s formal approval system change from an examination and approval system to tacit permission. It is expected that the approval time for regulatory approval of clinical trial applications will be shortened from 265 days to 65 days.


Acceptance of foreign clinical data

In July 2018, the National Medical Products Administration (NMPA) published “Technical Guidelines on Accepting Overseas Clinical Trial Data”(See Cortellis Regulatory Intelligence, IDRAC 267620).

As highlighted at the DIA China meeting, the advantages of accepting foreign data to support an NDA include:

  • Avoiding repetitive studies
  • Improving registration efficiency and prolonging market exclusivity
  • Allowing patients to get innovative therapies as soon as possible

Overseas clinical trial data are assessed according to the quality of clinical data, the efficacy and safety of indications and racial sensitivity. Assessment results are divided into three categories: full acceptance, partial acceptance and no acceptance.

According to “Optimize review and approval of drug registration” published by NMPA at the end of May 2018: For a foreign-marketed drug to prevent and treat serious life-threatening diseases without effective therapies available currently and orphan drugs, the imported drug registration applicant may directly apply for NDA with the foreign clinical data if there is no ethnic difference (See Cortellis Regulatory Intelligence, IDRAC276253).

Nevertheless, the acceptance of foreign data to support the NDA requires clarification of the ethnic difference and the impact of such difference on the safety and efficacy of the drug.

Mary Sun, pharmacist of clinical & regulatory at Zai Lab Ltd., made several recommendations to global drug developers in her presentation at DIA China, encouraging a globally simultaneous clinical development strategy and also urging early communication with regulators:

  • For legacy products (those already approved outside of China), the sponsor should examine the available data, understand how it is relevant to Chinese patients and ask the CDE for advice on the next step, whether that is filing a waiver or conducting a bridging study prior to the new drug application (NDA) submission in China, she said.
  • With an IND, the sponsor should consider a China development strategy as early as possible and integrate a China development program into global development programs if applicable, Sun said. Sponsors also should leverage CDE pre-IND and milestone meetings to obtain advice and reach agreement on China development strategy.


Global cooperation on use of human genetic resources

In order to obtain the relevant drugs and medical devices listed in China, the clinical institutions using China’s human genetic resources for international cooperation in clinical trials, and those not involving the exportation of human genetic resources materials, do not need approval. However, the partners shall submit the types, quantities and uses of the human genetic resources to be used to the State Council’s Science and Technology Administrative Department for the record before conducting clinical trials. The Science and Technology Administrative Department of the State Council and the Scientific and Technological Administrative Departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government shall strengthen the supervision of the filing matters.

Editor’s note:The Chinese regulatory documents highlighted in this article, noted by their Cortellis Regulatory Intelligence track number (IDRAC), are all collected, curated and translated in Cortellis Regulatory Intelligence, the timely and comprehensive solution that spans all regulatory functions across the biopharma R&D lifecycle.

This is the second of a two-part blog series from Cortellis on changes to the regulatory system in China. Here is part one: Aiming at world pharma stage, China embraces regulatory reforms.