medicines-medical devices-regulatory affairs
This post provides information on the ongoing changes to the EU the variation Regulation (EC) No 1234/2008 and guideline. Timeline of events leading to the publishing of the commission delegated regulation Date Event Call for evidenceFeedback period29 August 2023 – 26…
The TGA has responded to the issues raised in the 2021 Report on Cell, Gene and Tissue Regulatory Framework in Australia: Stakeholder Perspectives Background First introduced in May 2011, the regulatory framework for biologicals provides the legislative basis for the…
The idea of this post is to provide a snapshot of some milestones in the history of US drug regulation. Medicines regulation is by no means ever perfect but the legislation is constantly evolving. With each evolution, the intent is…