medicines-medical devices-regulatory affairs
Last updated on 29 August 2024 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…
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 provide 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 proceduresconducted outside the traditional ‘clinical trial site’, a concept usually…
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…
Last updated:16 August 2023 See updates at the end of the post. The UK MHRA will introduce a series of new measures with support from partners to make it faster and easier to gain approval and to run clinical trials…
Last updated: 22 December 2022 Swissmedic has updated its position paper on Decentralised Clinical Trials (DCTs) with medicinal products from version 1.1 to version 2.0 of 15 December 2022. According to Swissmedic, revisions and clarifications have been added where necessary.…
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published Version 1.0 of the recommendation paper on decentralised elements in clinical trials . The 33 page document was adopted by the Accelerate Clinical Trials in…
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…
The current clinical trial regulatory framework has served Canada well by upholding high standards and patient safety. A modernised clinical trials regulatory framework is needed in light of: ongoing and accelerated technology advances the development of new types of promising…