TGA Sunscreen Guidance

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] Australia’s Therapeutic Goods Administration (TGA) announced in late January a revision to its regulations covering sunscreens.  The revision was written in consultation with Australia’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and the pharmaceutical and cosmetics industries.  A draft for public consultation was published in 2010, and the preparation of the final guideline “has taken into account the comments received as a result of the consultation and also the changes to the Australian and New Zealand Sunscreen Standard,” the announcement notes.  Major changes include: ● adoption of the ISO 24444:2010 in vivo test procedure for determining sun protection factor (SPF) ● increasing the maximum SPF that may be claimed on the label of a sunscreen product from SPF 30+ to SPF 50+ ● limiting of the permitted SPF claims to specific numbers ● adoption of the in vitro test procedure in ISO 24443:2012 for determining broad spectrum performance, and ● making “broad spectrum” performance mandatory for all primary sunscreens and for those secondary sunscreens classified as “therapeutic sunscreens” and regulated by TGA.  In November 2015, FDA also revamped its regulations regarding sunscreens with the publication of four draft guidances as required by the Sunscreen Innovation Act (SIA) of 2014 covering ● format of submissions by the sponsor to support GRASE status ● withdrawal of a sunscreen application ● requesting an advisory committee review, and ● safety and effectiveness data to determine whether a sunscreen active ingredient is GRASE (IPQ “Monthly Update” Nov./Dec. 2015 p. 76).
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