4. Regulatory Authority (RA)/Competent Authority (CA)

Clinical Trial Applications (CTAs) are reviewed by the PMDA.

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant. 

The documents required as part of a CTA are as follows: 

1. A statement that scientifically justifies the reason for the sponsor to initiate the clinical trial
2. The clinical trial protocol
3. Informed consent form
4. A Case Report Form (CRF) sample
5. The current Investigator’s Brochure (IB)

https://credevo.com/articles/2018/08/16/japan-clinical-trial-regulatory-process/

4.2 Time required for RA/CA review and approval process and turnaround time if any query is raised during the review process. 

PMDA's review of the CTA normally takes 31 days. There is no set timeline for addressing agency queries.

4.3 Does the regulation support electronic submission?

Yes, PMDA accepts electronic submissions.  

4.4 Does the regulation require the applicant to be a Principal Investigator (PI)/Chief Investigator (CI)?

The PI can be the applicant but it is not mandatory. The applicant must be located in Japan.

4.5 Please describe the process of RA/CA submission for clinical trial approval. 

https://www.pmda.go.jp/english/review-services/reviews/0001.html

4.6 Does the RA/CA provide written acknowledgment of the submitted application? If not, describe how the application is tracked.

Yes, PMDA will confirm receipt of the application.

4.7 What is the relevant RA/CA fee in local currency/USD? Please provide as much information as possible (e.g. if the fee is different for notification/approval, initial submission, amendment, study with IMPD and study without IMPD, etc.)

The fee for a Clinical Trial Application is not listed on the PMDA's list of user fees.

4.8 Does RA/CA accept checks or can payment be made electronically? Please provide details on (1) A/C number; (2) A/C Name; (3) Sort Code; (4) Swift Code; (5) Bank address, etc. Where can remittance advice notices be sent?

Fees are normally paid electronically.

4.9 Is there any guidance tool available for making an electronic application? If yes, provide the link and/or step-by-step instructions.

Yes. Please refer to this document by PMDA.

4.10 Does RA/CA require any screenshots/mock screens for participant-facing materials?

Whenever patient-facing materials are in an electronic format, screenshots should be provided.