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Prescription medicines registration process

3 August 2020

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Phase 6: Expert advisory review

5.6.1 Objective

a diagram showing the steps of the expert advisory review phase

After completion of the second round assessment phase, the evaluation reports are considered by the delegate. The delegate may seek independent advice on issues concerning the application.

The main advisory group for prescription medicines is the Advisory Committee on Medicines (ACM). Specific issues may also be referred to the Pharmaceutical Subcommittee (PSC) of the ACM.

The registration process timeline is structured to align with the ACM meeting schedule. Where the delegate seeks advice from a committee other than the ACM, the TGA will seek to align the process to ensure appropriate expertise and advice is provided within the overall timeline for the registration process. Should alignment not be possible, the TGA will discuss the issues with the applicant.

Comments from the applicant in relation to perceived errors of fact or major omissions in the second round assessment reports for those applications referred to the ACM are also considered.

Information on each of the advisory committees is available on the TGA website.

5.6.2 Milestone 6

The TGA notifies the applicant of the advice received from the ACM.

5.6.3 Key dates

The expert advisory review phase commences on the day the delegate's Request for ACM advice and the second round assessment reports prepared by the quality, nonclinical, clinical and RMP evaluators are sent to the applicant. This date is at least 23 working days prior to the proposed ACM meeting.

The applicant must ensure that:

  • the pre-ACM response is received by the committee secretariat at least 13 working days before the meeting date. The cut-off dates for applicant's Pre-ACM response for each ACM meeting are posted on the TGA website.
  • comments in relation to perceived errors of fact or major omissions in the second round assessment reports are received by TGA at least 13 working days before the meeting date.

The expert advisory review phase ends when the ACM advice is sent to the applicant on the 15th of the month of the ACM meeting (or the following working day where the fifteenth of the month falls on a weekend or public holiday in the Australian Capital Territory).

5.6.4 Advisory Committee on Medicines

5.6.4.1 Request for ACM advice

The TGA delegate will review the evaluation reports and prepare a Request for ACM advice if independent advice from the ACM is required on aspects of the application.

The delegate is not obligated to refer an application to an expert advisory committee. At the time of preparing the Planning letter it may not always be clear whether an application will require ACM advice; however, for applications other than those to register a new generic medicine, the Planning letter will identify the ACM meeting allocated to the application should the delegate decide to refer aspects of the application for advice.

When preparing the Request for ACM advice, the delegate will consider any outstanding issues from the evaluation process. The request contains a number of elements including:

  • an overview of the application including key findings from the evaluation reports
  • outstanding issues identified by the delegate
  • an account of the risks and benefits relevant to the proposed product and proposed indication(s)
  • a specific request for advice on any aspect of the application's characteristics, findings, or risk/benefit considerations
  • whether special registration conditions, PI changes, or risk management plan changes would be appropriate.

On completion, a copy of the request is sent to the applicant prior to the ACM meeting to allow the applicant to compile a Pre-ACM response. The Pre-ACM response is the applicant's opportunity to provide final comment on the application. Applicants generally compile a Pre-ACM response based on the evaluation reports and the delegate's Request for ACM advice. The applicant should ensure they address any outstanding issues raised by the TGA. More information on pre-ACM responses is available from the ACM Secretariat at ACM Secretariat.

The ACM does not make decisions and its advice does not constitute directions to the Secretary or the TGA delegate.

The ACM advice is published in the Australian public assessment report (AusPAR). The ACM minutes may also be provided to a number of overseas regulatory agencies as permitted under section 61(4) of the Act.

5.6.4.2 Applicant's opportunity to review evaluation reports

For applications referred to the ACM for advice, applicants should review and advise the TGA of any perceived errors of fact or major omissions in the second round assessment reports.

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.

5.6.5 Pharmaceutical subcommittee

The pharmaceutical subcommittee (PSC) provides advice to the ACM on the pharmaceutical chemistry, quality control, bioavailability and pharmacokinetics of prescription medicines proposed for registration in Australia.

The delegate considers any issues raised during the evaluation process and may refer a matter to the PCS for advice. The referral may occur at any time during the evaluation process. For example:

  • following the first round assessment phase
  • during the second round assessment phase, following the response to the consolidated section 31 request
  • prior to ACM meeting.

In addition, the ACM may advise the delegate to refer an issue to the PSC.

Applicants do not prepare a pre-committee response for the PSC.

5.6.6 What happens if an applicant misses a key date?

Where the applicant cannot provide a pre-ACM response to the ACM secretariat at least two weeks prior to the meeting date, the response will not be tabled for consideration by the ACM, but will be considered in the decision phase by the TGA delegate.

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