medicines-medical devices-regulatory affairs
Last updated on 4 June 2026 See history of updates below. This post is an attempt to provide an information resource for the Clinical Trials Regulation (EU) no 536/2014 (CTR). The information provided is by no means exhaustive. Click on…
The MHRA has provided a link to the webinar of Tuesday 15 October 2024 on Implementing the new UK Clinical Trials regulations. This webinar details the upcoming implementation of new clinical trial regulations in the UK. How you might use…
AEMPS has launched an accelerated evaluation procedure or fast-track with the aim of making Spain a more attractive environment for research into innovative medicines. In general terms, Regulation (EU) No. 536/2014 on clinical trials of medicinal products for human use establishes the maximum deadlines for…
Issue 76 (February 2024) of the HPRA Medicinal Products Newsletter has been published. As usual, it is packed with information and includes (but is not restricted to) the following information: 1) Clinical trials applications – Important dates and information Applicants…
This blog post provides basic information on decentralised clinical trials and links to guidance/resources available in various countries/region(s). What is decentralisation? Clinical trials on Investigational Medicinal Products are increasingly using procedures conducted outside the traditional ‘clinical trial site’, a concept…
The table below details the Timeline of proposed changes to the regulatory framework for clinical trials in the UK. Date(s) Event Notes 17 Jan -14 Mar 2022 MHRA public consultation on proposals for legislative changes for clinical trials. This consultation…
The TGA has published new guidance entitled Good Clinical Practice (GCP) inspection program – Guidance for GCP inspection of clinical trial sites for investigational biologicals and medicinal products Clinical trials of medicines and biologicals regulated under the Clinical Trial Notification…
This post is an attempt to provide the requirements for conducting clinical trials in the UK post Brexit i.e. since 1 January 2021. The information provided is by no means exhaustive.. Please refer to the resources at the end of…
The UK MHRA has issued new guidance on authorisations and procedures required to Import Investigational Medicinal Products (IMPs) from countries on a list, to Great Britain (GB). Information is also provided on the importation of authorised/unathorised: non-investigational medicinal products unmodified…
The TGA has renamed the Clinical Trial Exemption (CTX) scheme to the Clinical Trial Approval (CTA) scheme. The change more accurately reflects the nature of the scheme under the Therapeutic Goods Act 1989, which involves sponsors applying for the TGA’s…