New Zealand Seeks Feedback on Safety-Focused Changes to Paracetamol Labels

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...
ANVISA will implement new rules for medical device modifications in Brazil

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...
TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

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 HSA revises guidance and technical documents

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...
India Seeks Feedback on Mandatory use of QR Codes on API Packaging

India – Indian Pharmacopoeia joins global discussion group pilot

The international Pharmacopoeial Discussion Group (PDG) has accepted the Indian commission into a one-year pilot that is intended to expand its membership beyond the...

Asia – 3D-printed drug advancing to clinical trials in SE Asia

Craft Health’s tailored drug technology just received a boost. The Singapore 3D printed pharmaceuticals manufacturer announced it has raised S$1.42 million ($1.03 million) in...

USA – Industry asks FDA to expand scope of product quality assessment guidance

Stakeholders want the US Food and Drug Administration (FDA) to include biosimilars and other biologics regulated by the Center for Biologics Evaluation and Research...

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