In a surprise move, the State Council in China has recently released a directive announcing its view on reforming the drug and medical device review and approval process in China. The State Council oversees the Chinese Food and Drug Administration (CFDA), and it is noteworthy that these changes were announced at a high level, reflecting the importance of these changes and the high priority the current administration places on reducing the regulatory backlog in the CFDA.

 The overall changes planned are very significant with increased emphasis on quality of data and a premium for innovation, whilst improving the quality of generic drug submissions which potentially reduces the number of generics if the required quality standards are not met.

 The directive specifies a plan for the next three years, which includes goals to:

  •  Reduce the backlog of submissions in the CFDA by the end of 2016
  • By 2018 meet the required approval time of 6-8 months for new drugs
  • Improve the overall quality of submissions
  • Encourage innovation and fast track new molecules for approval that are considered innovative
  • Allow for inclusion of data from other countries in regulatory submissions
  • Provide more transparency and public access to information regarding the approval process and CFDA rulings
  • Encourage companies to do more of the core regulatory studies in China and researchers in China to participate in more multinational research
  • Expedite approvals for orphan drugs, paediatric, HIV, oncology and anti-infectives
  • Implement a simplified CTA process for innovative molecules
  • Greater flexibility on definition of marketing authorisation holder (MAH)
  • Encourage innovative devices to be submitted with faster approval process
  • Allow for simple “mature” devices to be approved by provincial FDA branches
  • Review of charges for applications every 5 years
  • Improve numbers and diversity of experience of staff in CFDA and allow for use of external experts

 The CFDA has released a number of new requirements over recent months including the notification on clinical trial data self-check and verification, and a guideline for international multi-center clinical trials. George Clinical anticipates that the State Council’s latest directive will be built upon by further directives from the CFDA in the next 3-6 months.

 The changes outlined by the State Council’s directive will have far reaching implications on drug development in China. Whilst China has always been perceived as a complex environment for clinical development, these changes will significantly increase the cost barrier to enter China, with a higher focus on quality. Companies will not only need to ensure that their partner in clinical development really understands China, but can also offer cost effective, international quality standards and solutions. Furthermore, we expect an increase in demand for innovative trial design to achieve maximum impact in China. George Clinical is a global CRO headquartered in Sydney, who has been conducting trials in China for the past eight years. We offer full service CRO capabilities, coupled with unparalleled access to research networks and scientific leaders to ensure efficient and effective trial designs.