Phase 7: Decision
5.7.1 Objective
The TGA delegate will determine whether the application is to be approved (possibly modified or varied) or rejected. Where any outstanding issues may affect the decision, the delegate may liaise directly with the applicant during this phase before finalising the decision.
For applications made under section 23 of the Act the applicant will be notified in writing of the decision within 28 days of it being made (Section 25(4) of the Act). The issuing of a decision ends the legislated evaluation period.
5.7.2 Milestone 7
A decision is made for approval or rejection of the application for a new registration or for a variation to a registration and the decision letter is sent to the applicant.
5.7.3 Key dates
For applications referred to the ACM/ACV for advice:
- the decision phase will commence when the ACM/ACV advice is sent to the applicant 10 working days after the Advisory Committee meeting
- the decision phase is completed when the applicant is notified of the delegate's decision 6 weeks after the ACM/ACV meeting.
For applications for new generic medicines:
- the decision phase will commence when the second round assessment reports, prepared by the relevant evaluators, are sent to the applicant
- the decision phase is completed when the applicant is notified of the delegate's decision 6 weeks after the second round assessment reports are sent to the applicant.
For other applications:
- the decision phase will commence when the second round assessment reports, prepared by the quality, nonclinical, clinical and RMP evaluators, are sent to the applicant
- the decision phase is completed when the applicant is notified of the delegate's decision 6 weeks after the ACM/ACV meeting that would have considered the application, if the application had been considered by the ACM/ACV.
5.7.4 Review and decision
5.7.4.1 Applicant's opportunity to review evaluation reports
Applicants will be given a period of 14 calendar days after the TGA issues the final evaluation report(s) in which to review and advise the TGA of any perceived errors of fact or major omissions.
Each identified error of fact or omission must be referenced to information previously submitted (Study number and location, for example, Module 3.2.P.4.3 Method validation, p.23). It is not appropriate to submit new data to negate a perceived error of fact or omission (see Section 2.5 Information). Although there is no limit to the size of an applicant's response, it is expected that the response to any one report should be no more than six single sided A4 pages and in a font no smaller than 12 point.
Responses to the assessment reports must be included in Module 1.0.2.
Applicants should also use this period to revise the draft PI based on recommendations in the evaluation reports. Please identify clearly on any revised documents:
- changes to the documents which accord fully with the recommendations of the evaluator
- changes which are partially in accord with the evaluator's recommendations, together with reasons for not fully adopting them (for example, by cross-referring to data or to the response outlining omissions or errors of fact in the evaluation)
- reasons for contesting the evaluator's recommendations
- new amendments, analogous to safety related requests, affecting safety matters.
Revised PI documents must be included in Module 1.3.1.
5.7.4.2 Delegate's review
The delegate reviews all documentation associated with the application and makes an assessment of the risks and benefits. The review may address a number of outstanding issues including suggestions for revision of the product information (PI) or risk management plan (RMP). It may also address outstanding general registration details. The delegate may negotiate issues with the applicant prior to making a decision.
5.7.4.2.1 Decision for approval
Where the delegate is satisfied that benefits sufficiently outweigh risks associated with a product, the delegate will send the applicant a decision letter for approval of a new registration (possibly varied or modified) or approval to vary a registration. There may be special conditions of registration associated with the approval; these may include the conduct of post-market activities by the applicant, or a revision of existing documentation. The decision letter will also set out the appeal rights.
5.7.4.2.2 Decision for rejection
If a delegate decides to reject an application, a formal statement of the reasons is included in the decision letter. In addition to the reasons for the decision, the letter will set out the appeal rights.
In cases where an ACM or ACV recommendation to reject an application is unexpected the delegate will usually contact the applicant to discuss the proposed actions.
5.7.5 What happens if an applicant misses a key date?
There is no obligation for an applicant to provide a response to the evaluation reports. If no response is received by TGA within the 14 calendar days period after the TGA issues the final evaluation report(s), the delegate will proceed to make a decision based on the available information.
Applicants are responsible for monitoring existing GMP clearances that may be due to expire prior to or during the decision phase. A delegate is unable the approve an application for a new registration unless:
- all Australian manufacturer(s) involved hold a valid licence for the relevant production steps
- all overseas manufacturer(s) involved hold a valid GMP clearance for relevant production steps.