This content is current only at the time of printing. This document was printed on 11 September 2020. A current copy is located at http://www.xlg888.com/node/106
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What is pre-application assistance?
Pre-application assistance (PAA) is designed to give applicants the opportunity to obtain technical advice before submitting an application, and reduce uncertainty for a specific prospective application.
PAA is provided on a fee-for-service basis which can take the form of a written response, a face-to-face meeting or a teleconference.
Applicants intending to submit a timeshift application must submit a PAA in order to develop an agreed project plan for their application. This includes project plans for Global Joint Reviews.
Applicants intending to submit primary and secondary applications are encouraged to seek PAA to confirm the inter-relationship between applications and the appropriate level of assessment for each of the secondary applications.
The fees charged for PAA directly relate to the complexity and effort required and have been divided into three tiers.
This tier is designed to support the early stages of preparing an application such as guidance and clarification on the types of assessments necessary for the proposed application.
For written assistance only there is a one month timeframe for this tier which extends to two months if a meeting is requested—this allows for setting up a mutually agreeable time and date.
Tier one assistance can provide advice on:
- planning an application
- the types of regulatory assessments likely to be needed for an application
- the relevancy of efficacy criteria
- likely assessment modules, fees and timeframes
- clarification of guidance documents on the website.
This is used for technical advice to support a particular application and to give applicants greater confidence that their proposed submission will contain relevant information to address the safety, efficacy and trade criteria.
There is a two month timeframe for tier two and it can include a meeting if needed.
Tier two assistance can provide advice on:
- types of supporting data or information appropriate to the application
- relevance or suitability of overseas data and/or assessment reports
- the types of trials needed to generate appropriate data
- a scientific matter relevant to an application
- the development of an agreed project plan for a timeshift application
- specific aspects of the design of a study or trial.
This advice level can include an appraisal of a specific study design and finalisation of project plans for Global Joint Reviews.
There is a three month timeframe for tier three and it can include a meeting if needed.
Advice provided can include:
- appraisal of trial protocols before commencement of studies
- assistance on a proposed new methodology or variations to existing data guidelines for generating data
- finalisation of project plans for Global Joint Reviews.
Note: advice provided about the adequacy of trial protocols does not guarantee that the data generated from the study will satisfy the statutory criteria.