Novotech Update: New policy reforms in China focus on reducing clinical trial start up times and improving site access
China currently has one of the largest treatment-naive patient populations in the world [1], with its population expected to increase to almost 2.5 billion in 2030 [2].
In a bid to provide deeper access to this growing patient pool and reform its clinical trial environment, the Chinese Food and Drug Administration (CFDA) recently issued four draft policies for public comment. Within these four draft policy changes, ‘Circular 53’ proposes several positive changes focused on removing current barriers and regulatory hurdles to undertaking clinical trials in China.
Here are the top five changes proposed by Circular 53 you need to know when planning your next clinical trial in China [3]:
1. Improved regulatory review timeframes – to just 60 working days!
Once submitted, if the CFDA’s Centre for Drug Evaluation (CDE) fails to object or question the regulatory application within 60 days, CDE will be deemed to have agreed to the application – allowing the applicant to start clinical trial activities. This change will greatly reduce delays in the clinical trial approval process.
2. Improved clinical trial site availability, flexibility and selection
China’s clinical trial site management system will change from being one of site accreditation to site registration and CFDA auditing. Under this proposed change, China will be able to expand its network of clinical trial sites and remove current time delays experienced by sites awaiting CFDA accreditation. This change in site management will allow sites which meet protocol criteria to conduct a clinical trial after completing a simple CFDA notification process. To maintain site quality, the site must pass inspection and auditing before resulting trial data will be accepted by CFDA. Hospitals, medical research and academic institutions will also be incentivised to participate in clinical research and trials; as their clinical trial capabilities and activities will be considered as part of their performance reviews and government ratings.
3. Reform of the ethics committee review process, greatly reducing time delays
Site ethics committee (EC) reviews will be able to take place in parallel toapplications to CFDA. Also, in the case of multi region clinical trials, once the EC review is completed by the principal trial site, other participating site ECs are able to follow the same conclusion. These two changes will reduce time delays and barriers to site start up.
4. Acceptance of foreign data [4]
Data generated outside China can be submitted as part of drug and medical device registration to the CFDA if:
- The trials undertaken comply with CFDA regulations
- Trial sites pass the CFDA on-site audits
- The data provided can prove there are no ethnicity differences which may affect the product’s safety or efficacy
This change removes previous confusion regarding the CFDA’s position on the inclusion of data generated outside China.
5. Access to investigational products in Phase II and III trials expanded
Access to investigational products would be expanded and allowed in Phase II and III trials where the drug or device is intended to treat life-threatening diseases with no effective treatment or has shown probable benefits in early stage studies.
Should Circular 53 and other supporting policy changes be implemented, China’s clinical trial environment will be taking strong steps forward in increasing its attractiveness and accessibility to sponsors globally.
For more information about the untapped benefits available in China and the rest of Asia, download our free joint Frost & Sullivan white paper, ‘Asia: Preferred Destination for Clinical Trials’.
Or to find out more about undertaking a clinical trial in China, feel free to contact us.
[1] Deloitte: The next phase: Opportunities in China's pharmaceuticals market, 2011
[2] EY, Insights: Middle class growth in emerging markets Hitting the sweet spot, 2013
[3] Ropes & Gray LLP: Lexology.com, CFDA calls for comments on key policy proposals, May 31 2017
[4] Covington LLP: CFDA Releases Ground breaking Drug and Device Policies for Public Comment, May 23 2017