How to make best use of your Part II Expert Report

Part II Expert Reports are provided to the Drug Safety and Evaluation Branch as part of an application to register a drug product. This type of application relates mainly to prescription-only drugs and Non-Prescription injectables.

As far as possible, Part II evaluators use the expert report as the basis of their own report. It is in the sponsor's interest that this happens so that the company's own arguments are presented directly to PSC. EC volume IIA (1993), p15, states: "It is important to emphasise that well prepared Expert Reports greatly facilitate the task of the competent authority in evaluating the dossier and contribute towards the speedy processing of applications."

The Expert Report should be seen as an opportunity for sponsors - not simply a requirement.

Balance Expert Reports need to be balanced, scientific and based on the data submitted. If the expert report is written in the form of a promotional document, it cannot be used as the basis of the Part II evaluator's report. EC volume II p66, states: "It is important to note that the Expert Report should include a critical discussion of the properties of the product. The expert is expected to take and defend a clear position on the product in the light of current scientific knowledge. A simple factual summary of the information contained in the application is not sufficient."

The word "critical" is used in its alternative meaning "containing careful or analytical evaluations" (Collins English Dictionary, Australian Edition, 1979), which means it should include both positive and negative viewpoints. EC volume II states: "[An Expert Report] must be worded so as to enable the reader to obtain a good understanding of the properties, quality, the proposed control methods...the advantages and the disadvantages of the product." (p67)

"It is assumed, since the pharmaceutical expert has written and signed his Expert Report, that he is fully convinced that the product as developed is of the appropriate quality and that the proposed control tests and limits are those appropriate to ensure that the routinely manufactured batches continue to meet this quality requirement. The pharmaceutical expert should therefore not state this as his conclusion but instead critically review and discuss the elements of the dossier and tabulated summary which led him to this view." (p71)

Completeness

Pages 72-77 of EC volume II provide useful suggestions as to what might be discussed in a Part II Expert Report. For example, the suggested discussion of how clinical trial batches (particularly those used in pivotal studies) compared with the proposed registration product provides an opportunity for the sponsor to present a case to TGA and PSC/ADEC.

Expert Reports should be complete. Incomplete reports will attract questions from the evaluator.

Length

EC guidelines volume II Annex II p68 indicate the usual length of Expert Reports. The Part II report should "normally be less than 10 pages".

The TGA will, if possible, use the Part II Expert Report as the basis of the Part II evaluation by making annotations in the wide right-hand margin allowed for the purpose. The annotated expert report is then submitted to ADEC's Pharmaceutical Subcommittee.

However the agenda papers for PSC and ADEC tend to be voluminous and, if expert reports are unduly lengthy, the tendency is for evaluators to prepare their own evaluations rather than use the Expert Report as a base. Sponsors are therefore advised to conform with the guidelines on page length.

Electronic form

Part II evaluators often find that the required margin for annotations provides insufficient space and that they need to prepare an additional file note.

Consequently it is helpful if sponsors provide the Part II Expert Report in electronic format, preferably on a 3.5" disk in WordPerfect, so that the evaluator's comments can be added electronically. Evaluator comments will be clearly distinguished in a different typeface such as italics.