Listen to What Is...?
What is CDE?
A Clinical Trial Application (CTA) is a key document that is submitted to the Regulatory authority of a specific country to obtain approval for conducting clinical trials. In China, the National Medical Products Administration (NMPA) is the central Regulatory authority that is responsible for reviewing and approving CTAs.
Contents of a CTA
A CTA must contain detailed information on the proposed clinical trial, including:
- The Investigational Medicinal Product (IMP) to be tested.
- The clinical trial designs.
- The risks and benefits of the clinical trial with respect to the participants.
- The respective qualifications of the investigators.
- The measures that will be taken to protect the participants.
The NMPA reviews the CTA to ensure that the clinical trial is conducted in a safe and ethical manner. Once the NMPA approves the CTA, the clinical trial can commence.
Why is it Important to Submit a CTA?
Submitting a CTA is important for the following reasons:
- It ensures that the clinical trial is conducted in accordance with the highest ethical and scientific standards.
- It helps safeguard the participants.
- It increases the likelihood of the NMPA accepting the results of the clinical trial, which is necessary for marketing the IMP.
How to Submit a CTA?
The process of submitting a CTA varies from country to country. However, here are some of the general steps that are common to all CTAs:
- The sponsor of the clinical trial must prepare a CTA document, which should contain all the information that is required by the NMPA.
- Once the sponsor has prepared the CTA document, they should electronically submit it to the NMPA for review.
- The NMPA will then review the CTA document and may, in the process, request the sponsor for additional information.
- Once the NMPA approves the CTA, the sponsor can begin the clinical trial.
Are you ready to learn more about CTAs and their submission process? Get in touch with Freyr’s expert Regulatory team today!