Resources

Brazilian National Commission on Ethics in Research – CONEP/CNS has published on its website a Circular Notice, which provides guidance on…

This final guidance supersedes Qualification of Medical Devices Development Tools: Guidance for Industry, Tool Developers, and Food and Drug…

Health Canada has announced the implementation of guideline S12 on nonclinical biodistribution considerations for gene therapy. The guidelin…

There have been so many changes in the clinical trial framework in Italy including four new decrees concerning clinical trials on medical de…

Ministry of Health (MOH) Indonesia published news about Filling in Medical Devices Dictionary Data. Based on Government Regulation No. 46 of…

Taiwan Food and Drug Administration published Guidelines for Decentralized Measures for the Implementation of Drug Clinical Trials. Below is…

UK’s MHRA announced the Software and AI as a Medical Devices Change Programme last year to ensure regulatory requirements for software…

The Italian Medicines Agency (AIFA) recently published news regarding a new document ‘Questions & Answers Version 1.0’. In o…

US FDA recently released the draft guidance on decentralized clinical trials and has also scheduled a webinar to discuss this draft guidance…

The Food and Drug Administration (FDA Philippines) published news regarding guidelines about relying on the decisions of other regulatory ag…