This guidance is for sunscreen manufacturers who must comply with the PIC/S Guide to Good Manufacturing Practice for Medicinal Products, namely manufacturers of sunscreen products that are regulated as therapeutic goods by the TGA.
In Australia, many sunscreens are regulated as therapeutic goods because of their important role addressing public health issues. As such they must comply with the Therapeutic Goods Act 1989 (the Act), the Therapeutic Goods Regulations 1990 (the Regulations) and any other relevant regulatory requirements.
Details on the therapeutic sunscreen regulatory framework are available at Australian Regulatory Guidelines for Sunscreens (ARGS). Therapeutic sunscreens must comply with the Australian/New Zealand Sunscreen Standard currently adopted by the TGA.