Significant changes are ahead for clinical research in China. The Public Consultation Notice for Policies to Encourage Innovation and Reform in Regulation of Drug and Medical Device Clinical Testing was released by the CFDA on 11 May, 2017. These proposed changes herald an exciting new era for drug and device development. If implemented in full, these proposed changes will standardise regulatory requirements, l allow for greater use of foreign data broadening eligibility of sites to conduct trials, provide greater transparency of the Ethics processes and ultimately shorten approval timelines.
When implemented (in the next 3-6 months) the new guidelines will have a significant impact on the overall regulatory climate in China and provide a significant stimulus for conducting trails in China.
So what are the proposed changes and how will they impact the sector?
The draft guidelines contain several changes that will have the broad impact of streamlining the regulatory requirements of the Chinese FDA with other major players around the world. The main changes are:
- Change from accreditation of clinical trial sites to registration of clinical trial sites;
- Support of investigators and clinical testing organizations to carry out clinical trials;
- A smoother Ethics Committee System;
- Increased Efficiency of Ethics Review;
- Improved clinical trial review process;
- Acceptance of overseas clinical trial data;
- Greater support for exploratory clinical research.
Thus, the proposed changes represent a significant opportunity for investment in the Chinese R&D sector. It shows a proactive response by a regulatory body keen to improve the overall drug development process and make new medicines available faster for the Chinese population. Together with a greater engagement with the ICH process these changes will improved harmonised drug registrations in China and speed up the drug approval process.
George Clinical is a leading independent Asia-Pacific based clinical research organisation (CRO) with global capabilities, differentiated by scientific leadership, innovation and extensive investigator networks. With staff operating in 11 countries, George Clinical provides the full range of clinical trial services to biopharmaceutical, medical device and diagnostic customers, for all trial phases, registration and post-marketing trials. George Clinical combines scientific and clinical leadership with expert trial delivery capability to create a distinctive world-class service.