Industry dominates AusPAR use

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The results of a new survey show ‘regulatory intelligence’ is the most common use for TGA Australian Public Assessment Reports (AusPARs).

According to the regulator, the purpose of the survey conducted between May and July was to help identify the audience for AusPARs, understand what they are being used for and determine the usefulness of their content.

AusPARs are only prepared for products containing a new active ingredient or for new therapeutic uses or major variations to already registered products. They contain extracts from TGA reports prepared as part of the registration process.

Of the survey’s 105 respondents - 68 per cent were in the life sciences and biopharmaceutical industry, 14 per cent healthcare professionals and 10 per cent government employees.

On the question of what respondents use AusPARs for, 3 per cent said 'academic research', 11.4 per cent said 'government related', 10.5 per cent 'personal interest', 20 per cent 'market research' and 4.8 per cent 'medical prescriber interest'.

The majority (50.5 per cent) said 'other'. Of these, about 40 per cent said they used the information for ‘regulatory intelligence’, "that is, to understand dossier issues, to gain insights into the regulatory decision-making process, and to understand the course of evaluations and trends in the TGA’s perspective on drug development programs and regulatory decision making.

"It was also mentioned that AusPARs were used to understand regulatory hurdles faced by other companies when seeking to register similar therapeutic products."

Approximately 20 per cent of the 'other' respondents said they used AusPAR information for ‘competitor intelligence’.

Almost 80 per cent of respondents said AusPARs serve their purpose of providing transparency of the TGA's decision process on prescription medicines 'very well' or 'well'.

In terms of additional information for possible inclusion in AusPARs, 23 per cent said that they would like to see a plain English, consumer-friendly summary included with each. 18 per cent said they would like to see an improved AusPAR structure or a more detailed description of the decision and the rationale for the outcome, particularly in relation to rejections and appeals.