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Accestra Consulting Group has put together the top 10 most asked questions and answers to China’s clinical trial exemption and IND application (CTA).
 
China’s Center for Drug Evaluation (CDE) allows a drug Marketing Authorization Holder (MAH) to apply for clinical trial exemption in China if a drug is already approved for marketing in other countries.
 

How to qualify for a clinical trial exemption

Qualifying for a clinical exemption depends on:
  • An evaluation of the existing clinical data conducted overseas,
  • The drug clinical need and urgency in China, which can you can discuss with CDE before the Investigational New Drug (IND) application in a pre-IND meeting.
 
If no exemption is possible, clinical studies need to done in China according to CDE’s protocol. You will also need to register on the CDE database for government supervision and public review.

 

Top 10 Questions to China’s clinical trial exemption and IND application

Q1. I have finished drug clinical trials outside of China, can my clinical data be accepted for registering the drug in China?

It depends. According to the Technical Guidelines for Acceptance of Drug Foreign Clinical Data (National Medical Products Administration [2018] Decree No.52), the acceptance of drug foreign clinical data depends on the data quality, drug efficacy, safety, and ethnic factors. Acceptance will be possible if your data is:

  1. Authentic, reliable, in compliance with ICH guidelines for Good Clinical Practice (GCP) and Chinese regulatory requirements for on-site inspection and audit.
  2. Sufficient for the evaluation of drug efficacy and safety for the target indication.
  3. Sufficient to demonstrate that no impact of ethnic factors has been identified on drug efficacy and safety.

Need a compliance assessment of your data? Please contact us on info@accestra.com

Q2. If my data is accepted, will clinical trials be exempted in China? If not, what clinical trials will be required?

If your clinical data fulfills all the criteria for acceptance and your drug has been approved outside of China (in the US, EU, Japan etc.) for an urgent or unmet clinical need, such as a life-threatening or rare disease, according to the Technical Requirements for Clinical Trials on Drugs Marketed Overseas but Unavailable in China (Center for Drug Evaluation [2020] Decree No.29), clinical trials could be exempted in China.

If your clinical data is evaluated to be insufficient by China CDE, clinical trials will be required in China in forms of bridging studies or comprehensive clinical trials depending on the overall data quality.

Q3. Can I communicate with CDE about the feasibility of clinical trial exemption before filing an IND application?

You can apply for a pre-IND meeting with CDE to evaluate your clinical data and discuss the feasibility of exemption.

If no exemption is possible, you can provide CDE with a strategy for clinical studies in China and ask for their opinions.

Q4. How can I file an IND application in China?

After the pre-IND meeting file an application to CDE with your clinical study plan and detailed protocol for China, CMC, nonclinical and clinical data as well as other required materials such as the Investigator’s Brochure and justification for IND exemption.
 
Once your application is accepted, CDE will conduct a technical review within 60 workdays. In the case of IND exemption, you will be notified.
 
In other cases, CDE will determine whether clinical studies can be conducted in China based on the submitted data and strategy.
 
If approved, an IND approval will be issued by default in 60 workdays.
 
Finally, you need to file an application for ethics approval before starting the studies.

Q5. It’s day 61 after my IND application, can I start with my clinical trials in China?

Not yet. You need to register your clinical trials on the Platform for Drug Clinical Trials Registration and Information Publishing with China CDE for government supervision and public review (Fig. 1).

Fig.1 Platform for Drug Clinical Trials Registration and Information Publishing

Fig.1 Platform for Drug Clinical Trials Registration and Information Publishing

 

Q6. I need to conduct bridging studies in China, should I also register on the CDE platform?

Yes. All clinical studies in China need to be registered on the platform including:

  • Phase I-IV clinical trials,
  • bridging studies,
  • pharmacokinetics (PK)
  • pharmacodynamics (PD),
  • bioavailability (BA),
  • and bioequivalence (BE) studies.

 

Q7. How can I register on the CDE platform? Do I need an account?

You need an account for the platform.
 
To open an account you will need the following information:
  • Applicant name,
  • Company name and address,
  • Drug name,
  • Indication,
  • IND approval number,
  • Approval date.
For a complete list of information or registration services, please contact info@accestra.com

Q8. Is there a timeline for registration?

The timeline of clinical trial registration is as follows (Fig. 2).

  1. Fig.2 Timeline of Drug Clinical Trials Registration

    Fig.2 Timeline of Drug Clinical Trials Registration

    IND approval: An IND approval is issued by default in 60 wd by CDE.

  2.  Registration: Register your clinical study on the above-mentioned platform within 1 year after IND approval so that the relating data will be published for public review before the first subject is enrolled.
  3. First Subject Enrollment: The first subject enrolls in the study.
  4. Enrollment Date Recording: Record the enrollment date on the platform within 30 workdays.
  5. Updates & Changes: If any updates or changes during the study, submit the data within 20 workdays on the platform.
  6. End of Clinical Study: After the study ends, update the results on the platform within 1 year.

 

Q9. My drug has multiple strengths, and each strength has been approved for clinical studies in China. Should I register these strengths separately?

You do not need to register them separately if you have the same clinical study protocol for all the drug strengths.
 
You can register one strength and include the others in the “relating IND approval numbers”.
 
Meanwhile, the IND approval notifications of all the strengths should be uploaded to the platform.

Q10. Will my registration data be published on the CDE platform for public review? If so, when will CDE publish the data?

CDE will only publish part of your registration data on the platform for public review without disclosing confidential information.

The data will be published in 2 weeks each time you submit updates to CDE.

Contact Accestra Consulting Group
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