New Eealand – New Zealand updates pharmacovigilance guideline
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has updated its guideline on pharmacovigilance after receiving support for changes it proposed late...
Brazil – ANVISA approves skinny labeling in Brazil
On December 6, the Board of Directors (DICOL) of the Brazilian Food & Drug Agency (ANVISA) passed new regulations accepting an exemption to allow...
New Zealand – Guidelines on the Regulation of Therapeutic Products in New Zealand
Medsafe requires evidence of compliance with Good Manufacturing Practice (GMP) for sites
used to manufacture and pack medicines. This evidence is required for medicines in...
Australia – Nitrosamine risk assessment in Category 1 prescription medicine registration applications
Sponsors need to be aware of the global issue relating to nitrosamine impurities in medicines. In particular, they should be familiar with the known...
Singapore – Singapore’s HSA finalizes LDT guidelines
Singapore’s Health Sciences Authority (HSA) has finalized guidance intended to help clinical laboratories understand the regulatory requirements for tests they develop internally.
To date, HSA...
