Australia: TGA Repeals Advertising Permission for Nicot…
The Therapeutic Goods Administration (TGA) has repealed the Advertising Permission for Nicotine, effective from 1 January 2024. This move co…
Read more
Increased Risk of Neurodevelopmental Disorders in Child…
New research indicates a higher risk of neurodevelopmental disorders in children when fathers took valproate three months before conception.…
Read more
ANVISA adopts new flows to request for consent to impor…
ANVISA (Brazil) Introduces Streamlined Processes for Importing Experimental Medicines: New procedures exclude pre-boarding inspections for d…
Read more
NPRA published Guidance Document and Guidelines for Reg…
The NPRA has released a revised edition of the biosimilar product registration guidelines in the second edition of the Guidance Document and…
Read more
HSA Singapore: 4 Products Found to Contain Potent or Ba…
Health Sciences Authority (HSA) of Singapore has issued a public alert regarding four products sold online that were found to contain potent…
Read more
Seizure Of Over $2 Million Worth Of Illegal Medicine Im…
In a joint effort, the Therapeutic Goods Administration (TGA) and Australian Border Force (ABF) successfully seized over $2 million worth of…
Read more
US FDA Releases Draft Guidance on Translation for Good …
This US FDA draft guidance is aimed at assisting sponsors and nonclinical laboratories involved in the development of drugs to ensure that t…
Read more
ANVISA updated procedures for imports of medicines incl…
ANVISA has updated its import authorization procedures for medicines and substances subject to special control. It is worth remembering that…
Read more
Argentina ANMAT proposes guidelines for decentralized c…
Argentina ANMAT guide outlines the requirements for decentralized elements in clinical pharmacology studies, including roles and responsibil…
Read more
Malaysia Decentralised Clinical Trial (DCT) Guidance Do…
Malaysia has released its first Decentralised Clinical Trial guidance document, which provides detailed guidance on implementing decentralis…
Read more