What is CTN in Japan?

Clinical Trial Notification (CTN) is a Regulatory process in Japan that helps ensure the safety and efficacy of new drugs placed on the market, largely overseen by the Pharmaceuticals and Medical Devices Agency (PMDA). The CTN system applies to drugs with active ingredients that differ from approved drugs or drugs with the same active ingredients but administered via a different route. The process involves the submission of a clinical trial protocol to the Ministry followed by a review period of approximately thirty (30) days. Once the review is completed, the sponsor can proceed with the clinical trial.

The PMDA strongly encourages sponsors to utilize the consultation system, as it may reduce the review time for applications. Clients who plan multinational trials with sites in Japan may choose to skip the pre-CTN stage. However, they can request a session before filing their New Drug Application (NDA) to confirm that their trial data is adequate.

The number of consultations required for a drug varies based on the therapeutic category, and the processing of the consultation request takes approximately two (02) months. The PMDA assigns the same set of reviewers to a particular study throughout the lifecycle of a product, which in turn ensures consistent guidelines for the development of new drugs and medical devices.

The CTN submission process is crucial for pharmaceutical companies operating in Japan. The country boasts a large population of around 126 million people, which provides a significant pool of potential study participants for clinical trials. Additionally, Japan has a high incidence of certain diseases, such as gastric cancer and hepatitis C, making it an attractive location for clinical trials targeting these conditions. The PMDA strives to speed up the review process by setting accelerated timeframes; this has, in turn, resulted in it now emerging as the second-fastest Health Authority (HA) with respect to NDA approval time among all major Regulatory agencies. The average approval time has been reduced to approximately ten (10) months, which is twice as fast as the speed in 2010.

The CTN submission process involves the following steps:

• Clinical Trial Protocol Submission: Sponsors of clinical trials must submit the clinical trial protocol to the Ministry beforehand, as specified in the Ministry of Health, Labour and Welfare (MHLW) Ordinance.
• Review Period: After submitting the protocol, the Ministry conducts a review of the clinical trial, which takes approximately thirty (30) days.
• Clinical Trial Approval: Once the review is completed, the sponsor can proceed with the clinical trial.

In conclusion, the CTN submission process is an essential Regulatory process in Japan's PMDA that ensures the safety and efficacy of new drugs in Japan. The CTN submission process is crucial for pharmaceutical companies operating in Japan, as the country has a large population who can participate in clinical trials and is an attractive location for trials targeting certain diseases.

To get expert guidance on CTN submissions and end-to-end Regulatory support in Japan, contact our experts now!