On April 14, 2026, the Therapeutic Goods Administration (TGA) issued a clarification regarding the scope of the Industrial Chemicals Environmental Management Standard (IChEMS) and its applicability to therapeutic goods. The statement confirms that IChEMS, which prohibits the import, manufacture, and use of certain hazardous chemicals including PFAS, UV-328, and Dechlorane Plus, does not apply to chemicals used in therapeutic goods. As a result, medicines, medical devices, and biologicals-including their components and associated packaging-are exempt from these prohibitions. The TGA emphasized that it does not regulate environmental safety or grant exemptions under IChEMS but encourages manufacturers to reduce reliance on listed chemicals where possible. It also advised sponsors to report any potential supply disruptions caused by IChEMS restrictions. The clarification aims to provide regulatory certainty to stakeholders and ensure continued availability of essential therapeutic goods while supporting broader environmental protection objectives.
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