In our May newsletter, we mentioned that in July, Japan would start allowing online submissions. At that time, online submissions of new drugs, new medical devices, improved medical devices with clinical data, IVDs for new products, and IVDs with clinical data were acceptable.
Now, as of January 11, 2023, the PMDA has announced that other product categories could also be done via an online application such as – generic drugs, medical devices without clinical data, and IVDs without clinical data.
In addition, additional regulatory licenses like FMR, FMA, etc. can now be done online too. Also, when a future change is expected at the time of the initial Shonin application, the applicant can include the expected change in the initial application, and after the evidence has been accumulated and the data are consistent with what the applicant expected, the applicant is allowed to register such change with “Todokede” or notification, not a partial change submission.
For online applications, applicants can use the portal called the “Gateway system”, which is operated by the PMDA.