Pre-submission meetings

A pre-submission meeting with the EMEA Secretariat is encouraged and is free. It is especially advisable if it is the applicant s first experience in seeking scientific advice, and should usually be scheduled about 1 to 2 months before submitting a request. This meeting is valuable for guidance on the scientific advice procedure and for help with the structure/content of the request. There is an EMEA Scientific Advice Guidance Document available to the applicants. The applicant should inform the EMEA Secretariat of the intention to submit an application about 2 weeks before the submission of request and then, once the appropriate fees have been paid, the procedure can start. 

The applicants are generally advised to have a pre-submission meeting with the EMEA Secretariat. On receipt of a valid application, COMP appoints an EMEA coordinator and a COMP member as a coordinator (Day 0). These two prepare a joint report for discussion at the following... 

Two classes of new data may be submitted after an application has been accepted - additional data and supplementary data. Additional data are data identified at a pre-submission meeting that TGA agrees to accept during the course of an evaluation at a predetermined date, such as the results from an ongoing clinical study. 

In general terms, additional data may not be submitted once an application has been accepted for evaluation, unless specifically asked to do so on a Section 31 request. However, in some instances there is an opportunity to submit additional data that is identified at the time of the initial application, or at a pre-submission meeting. In such cases, the TGA has the discretion to accept this additional data for evaluation and it is possible that an extended evaluation time may be applied. There are also limited opportunities to submit supplementary data, at the initiation of the sponsor, to address deficiencies that may have been identified in the TGA s assessment of the dossier. In these cases, mutual agreement to stop the clock is essential, and further evaluation fees may also be levied. 

Free pre-submission meetings with persons or companies ( sponsors ) on authorisation applications... 

As preparations for the submission of an NDA begin, there needs to be a pre-NDA meeting with the EDA reviewing division. This meeting focuses on format, not content, and is important to eliminate delays that can occur when an NDA does not meet the specific needs of the assigned reviewers at the EDA (21 CER 312.47). The sponsor should provide to the FDA an idea of the t)q)es and volume of information to be submitted, as well as the plan for data summary, presentation and analysis. The FDA should provide to the sponsor any specific requests for the display and analysis of data. Electronic formats and requests have become more routine, and a good understanding of what is plaimed and needed can help improve efficiency and minimise later difficulties. 

Purpose of Meeting. The purpose of the pre-NDA or pre-BLA meeting is to discuss filing and format issues. The CMC portion of the pre-NDA or pre-BLA meeting is a critical interaction between the CMC review team and the sponsor to ensure the submission of a well-organized and complete NDA or BLA. 

Typically, sponsors meet with the FDA to discuss the content and format of an NDA prior to its preparation. Such a pre-NDA meeting can be crucial for the sponsor to understand the content and format that will best facilitate the review process for a given submission. 

Pre-NDA meetings are held primarily to discuss the presentation and format of data supporting the application. Prior to the meeting, the sponsor should provide a summary of clinical studies submitted in the NDA, the proposed format for organization of the submission, and any outstanding questions. Although the primary purpose is to familiarize FDA staff with presentation and organization of the data to facilitate review, it also provides a final opportunity to discuss any unresolved problems or issues. 

At the end of Phase 2, the FDA and sponsors try to come to an agreement on how the large-scale studies in Phase 3 should be done. How often the FDA meets with a sponsor varies, but this is one of two most common meeting points prior to submission of a new drug application. The other most common time is pre-NDA—right before a new drug application is submitted. 

As one plans the formatting, there must be a clear understanding of how to separate the most frequently needed data from the supporting material. The FDA guidelines and meetings with the FDA, particularly the pre-NDA submission conference, is invaluable to the applicant, especially if unforeseen problems arise owing to the nature of the product or data. 

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