Regulatory round-up: 1 June 2026

The past week was lighter on major approvals, but still produced a useful spread of regulatory activity across North America, Asia-Pacific and Latin America. The US Food and Drug Administration used the period to push further into streamlined cancer drug development guidance, while Australia’s Therapeutic Goods Administration posted new medicine decisions and shortage-related tools.

Safety and post-market oversight were the bigger thread. Health Canada updated nitrosamine guidance and confirmed a Prescription Drug List change for pediatric melatonin use, while Malaysia’s National Pharmaceutical Regulatory Agency flagged a new important identified risk for Columvi. Colombia’s National Institute for Food and Drug Surveillance posted several medicine and biological product alerts.