Manufacturer audits Initial audit (year 1) Not required - - - Initial audit (year 2-5) Not required - 4 4 Surveillance audits Not required 1 in 2 yrs 2 in 3 yrs 2 in 3 yrs Post market audits If required - - - Biological evaluations Transfer medicines/devices - - 6 - Initial evaluations (year 1) - 8 0 1 Initial evaluations (year - 17 4 4 to standards file or Not required Approx 20% Approx 20% Approx 20% product dossier Other assumptions Regulatory support As required As required As required As required Growth Nil Nil Yes Yes Adherence to Cost Recovery Guidelines The Cost Recovery Guidelines recommend that an assessment of activities be made against a set of questions that will assist in determining whether cost recovery would be appropriate. Principle Discussion Would cost recovery unduly Pre-market approval of a biological will permit the stifle competition and manufacturer/sponsor to supply products in Australia. The industry innovation (for benefits of TGA approval are limited to the applicant none – example, through of the assessment work will benefit other sponsors. As costs ‘free can be identified for the activities undertaken, fees are rider’ effects)? considered to be an appropriate cost recovery mechanism. The calculation of the fee ensures all applicants are treated equitably and does not confer advantage on one applicant over another. That is, by imposing the fee on the biological industry, this should not stifle competition in the industry’s delivery of its end product. Would cost recovery be Cost recovery arrangements for biologicals are consistent inconsistent with with Government policy and are not inconsistent with other government policy policies. objectives?
Manufacturer audits Initial audit (year 1) Initial audit (year 2-5) Surveillance audits Post market audits Biological evaluations Transfer medicines/devices Initial evaluations (year 1) Initial evaluations (year to standards file or product dossier Other assumptions Regulatory support Growth Not required Not required Not required If required - - - Not required As required Nil - - 1 in 2 yrs - - 8 17 Approx 20% As required Nil - 4 2 in 3 yrs - 6 0 4 Approx 20% As required Yes - 4 2 in 3 yrs - - 1 4 Approx 20% As required Yes Adherence to Cost Recovery Guidelines The Cost Recovery Guidelines recommend that an assessment of activities be made against a set of questions that will assist in determining whether cost recovery would be appropriate. Principle Discussion Would cost recovery unduly stifle competition and industry innovation (for example, through ‘free rider’ effects)? Pre-market approval of a biological will permit the manufacturer/sponsor to supply products in Australia. The benefits of TGA approval are limited to the applicant – none of the assessment work will benefit other sponsors. As costs can be identified for the activities undertaken, fees are considered to be an appropriate cost recovery mechanism. The calculation of the fee ensures all applicants are treated equitably and does not confer advantage on one applicant over another. That is, by imposing the fee on the biological industry, this should not stifle competition in the industry’s delivery of its end product. Would cost recovery be inconsistent with government policy objectives? Cost recovery arrangements for biologicals are consistent with Government policy and are not inconsistent with other policies.
fees-cris-biologicals-110201-01.docx