FDA: Updated Nitrosamine Limits

Australia's regulatory authority, the TGA (Therapeutic Goods Administration), pursues a strategy of aligning its regulatory approaches as closely as possible with comparable international standards. These include the regulatory requirements of the EU, the FDA and the ICH. In this context, around 370 international scientific guidelines have already been adopted.

The Active Pharmaceutical Ingredients Committee (APIC) has published Version 3 of the document “GDP for APIs: How to Do” (June 2026) on its website. The document provides practical guidance on implementing Good Distribution Practice for active pharmaceutical ingredients.

“Today public health faces a new kind of challenge: speed. Diseases move faster and are more unpredictable than ever, racing across borders and continents.”, said Hadja Lahbib, Commissioner for Equality, Preparedness and Crisis Management, upon signing an EU4Health contribution agreement worth over 4 million euros with the World Health Organisation’s (WHO) Hub for Pandemic and Epidemic Intelligence in Berlin on 24 July 2026.