A new administrative notice entitled ‘Basic Principles Regarding Japanese Data in Cases Where Confirmatory Clinical Trials for Drug Used in Rare Diseases and Others Have Been Conducted Exclusively Outside of Japan’ was issued from Pharmaceutical Evaluation Division, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare (MHLW) as of October 23, 2024. This notice is considered to be one of the measures to improve the so-called ‘Drug Loss/Lag’ in Japan.
The original of the administrative notice is written in Japanese and its official English translation version is not available now. To read our unofficial English translation of the entire notification, please enter your information using the form below. The main points are summarized as follows;
Basic Principles Regarding Japanese Data in Cases Where Confirmatory Clinical Trials for Drugs Used in Rare Diseases and Others Have Been Conducted Exclusively Outside of Japan
| 3 requirements: | Examples: |
|
New Drug Application (NDA) filing without clinical trial results in Japanese patients | |
| 1) | Cases in which pivotal clinical trials have already been conducted outside of Japan appropriately (including cases when the interim analysis has been completed if the interim analysis results can be considered as the primary evaluation) | Positive results in Ph3 obtained in the US | ||
| 2) | Cases in which it is difficult to conduct additional clinical trials due to an extremely small number of patients and other reasons | Possible Orphan Drug in Japan | ||
| 3) |
Cases in which the overall benefits in Japanese patients are expected to outweigh the risks based on the available efficacy and safety information |
Topical administration or cell products |
As you see, if your products meet the above three requirements, you may be able to go to New Drug Application (NDA) filing without clinical trial results in Japanese patients. Our Innovative Drug Development (IDDB) Unit at Linical HQ (Osaka, Japan), which offers the following services including Strategic Partnering/Licensing, will guide and support you. If you are interested in taking advantage of this new notice to go to NDA filing early in Japan and maximize the value of your product, please contact us.
Authors:
Toshiaki Nagafuji Ph.D.
Chief Technical Officer, Head of Innovative Drug Development Business Unit
Linical H.Q., Japan