PMDA offers many types of consultations related to the development of drugs, medical devices and ATMPs (clinical trials, pre-market applications) as well as post-marketing measures: https://www.pmda.go.jp/english/review-services/consultations/0002.html
The appropriate consultation type must be selected depending on the matter to be consulted. PMDA’s types of consultation services include “Consultations” and “Pre-consultation meetings.”
“Consultations”
“Consultation” is a paid consultation that requires a fee. It is used, for example, when discussing with the PMDA whether the study design of the upcoming clinical trial is appropriate, and whether the data package for the approval application is appropriate based on the results of the clinical trial.
PMDA handles the consultation, including evaluating the data submitted by the person seeking consultation. PMDA also provides a written record of the consultation.
Although it is called face-to-face consultation in Japanese, it is not necessarily conducted face-to-face. Web meetings are possible at the request of the person seeking consultation.
“Consultation” cannot be applied for at any time, except for orphan designated products, and must be applied for on the first working day of the month two months prior to the month in which the consultation is to be conducted. For example, if you want to conduct a consultation (actual meeting) in May, the consultation application should be submitted on the first working day of March (if the 1st is a weekday, apply on the 1st).
After applying, the scheduling for the consultation begins. Then, the person seeking consultation should submit documents indicating the content of the consultation up to five weeks prior to the consultation (actual meeting) date. After the documents for consultation are submitted, PMDA reviews the documents, and an exchange of inquiry responses occurs by the day of the consultation.
Then, a record is provided by PMDA within one month after the actual meeting is conducted.
“Pre-consultation meetings”
“Pre-consultation meeting” is a free consultation. For example, it is used to organize the consultation items with PMDA before conducting “Consultation”.
Data evaluation, etc. is not performed in the pre-consultation meeting, so PMDA cannot answer questions that require data evaluation/interpretation (e.g., whether the clinical trial data can be used for pre-market approval application).
You can apply for a pre-consultation meeting at any time. When applying, you are asked to indicate your desired date and the topic you would like to discuss. If you have about one month to wait, an actual meeting can be held. As with “Consultation”, the meeting does not have to be face-to-face; you can request a web meeting, and if it is a simple matter, it may end with just a phone call from PMDA.
Also, no records of the pre-consultation meeting are created or provided by PMDA.
Summary
If you want to keep a record of your discussion with PMDA and receive a thorough evaluation, you will need to attend a paid “Consultation”. If you do not need a record or data evaluation, you can consider using a free “Pre-consultation meeting.”
In addition, there are restrictions on the date of application for “Consultation”, and it takes about three months from the consultation application to the actual meeting (about four months to obtain the records). On the other hand, you can apply for a pre-consultation meeting at any time, and the meeting can be held within about one month.
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