medicines-medical devices-regulatory affairs
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 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 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…
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 UK MHRA and Health Canada have collaborated to publish guidance to improve the safety of patients in clinical trials through improved quality of the periodic safety reports known as Development Safety Update Reports (DSURs). The guidance will improve the…
The UK MHRA has updated its requirements and guidance for Phase I accreditation scheme for clinical trials. It has also provided a new phase I accreditation compliance checklist and variation form. What is the Phase I accreditation scheme? It is…
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…