Revised Chinese regulations that brought a lot of changes in clinical trials and product registrations were received with lots of questions. If you have got questions that are yet unanswered, you are not alone. Many researchers, developers, and managers are not sure about one aspect or another on how to comprehend, act, or change their ways to meet new requirements in China. What could be a better solution to these issues than to ask the Chinese FDA officials directly? It seems, there could be an opportunity to do so.
Latest changes in Chinese regulations on clinical trials and product registrations
The changes in regulations started to appear somewhere in last year.
We had discussed them in detail in one of our previous articles.
Apart from clinical trials and product registration-related changes, there were new modifications in medical device regulations as well.
We are not going to discuss all of those changes here. However, some important points about clinical trial regulation changes are as follows.
Important changes in clinical trial regulations in China
- The China National Drug Administration (CNDA) in October last year announced plans to accept data from overseas clinical trials in a bid to speed up the approval of new drugs and medical devices
- Once the ethics committee from the leading investigation site completes its review of the trial application, no review by other sites involved in the clinical trial are required
- Introduction of an umbrella clinical trial authorization for all three phases of registration studies (instead of the original phase-by-phase approvals)
- Clinical trial samples can be tested by the sponsor or an entrusted third-party testing lab, rather than having to be tested by a government-accredited testing lab
- When investigating generic products, sponsors are able to choose their phase I trials sites, but new products still need to be investigated at phase I trial sites previously accredited by the CFDA
- New drugs and devices in development which meet an urgent clinical need or for rare disease in China can be approved for marketing conditions if the data from early or mid-stage trials show promising clinical value.
Ambiguities about the regulations
While there is a lot of information getting available on the changes, yet there are many ambiguities and questions that linger on. Most of them have been related to the practical changes that will be seen in the timelines and methods of approval.
In early this, Credevo team has had a chance to witness some good sessions by the experts in China regulations. Learning from these sessions was shared in one of the previous articles.
Important aspects related to the practical scenarios for marketing approval were discussed. However, your individual requirements and questions may be different. Thus, it serves better to consider them separately and discuss them with China FDA officials or experts.
Opportunity to connect with China FDA
If you have a chance to get an appointment with China FDA officials, it’s great. It’d be very wise to utilize this opportunity and get clarity about various aspects related to your projects.
However, if you have not been able to get an audience with China FDA or NMPA officials or experts, we would like to extend a helping hand.
Credevo team may get an opportunity to discuss with the Chinese FDA (Now called NMPA) officials and ask them questions related to clinical trials and product registration including medical devices in China. If you have any questions that need answers, do write to us. We will try to get answers to those questions from China FDA officials.
What are your questions to China FDA officials?
Provide your questions here in a brief and clear manner. Ensure to put up your company details and work email address.
Disclaimer and rules
- Questions are being invited only to support industry and research personnel in their efforts to meet new China FDA regulations.
- Credevo does not represent or intend to represent either China FDA (NMPA) or any organization (including those submitting their questions) in any regard.
- Only those questions, which appear clear and valid, will be considered. Credevo reserves the right to consider or not consider any questions. Credevo does not guarantee or assure that all questions submitted will be answered. It will be the prerogative of China FDA officials to answer any questions.
- No liability, claims, or legal representation can be imposed on any questions submitted and their answers. All submitting personnel is recommended to exercise their own judgment in the utilization of these answers.
- Questions received after Sep 9, 2019, may not be considered.
- Answers to the questions received will be published on Credevo websites. No direct communication with the submitting personnel can be assured or guaranteed.