PharmaSchool Regulatory Updates

PharmaSchool GCP & Regulatory Updates are notifications about changes, additions and new documents relating to the conduct of Clinical Trials. These are updated as and when new information is available. If you know of a document that should be referenced in this section then please let us know by emailing editor@pharmaschool.co

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Date: 21 July 2017
Document: MHRA GCP Inspection metrics report 1st April 2015 to 31st March 2016
Region: UK
Description: This report summarises findings from GCP inspections conducted by MHRA in the time period
URL: click here
Date: 07 April 2014
Document: Early Access to Medicines Scheme
Region: UK
Description: MHRA has launched its EAMS, which aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need.
URL: click here
Date: 29 October 2013
Document: MHRA Guidance on Serious Breaches
Region: UK
Description: This is version 4 of this guideline. The examples have been consolidated and updated.
URL: click here
Date: 25 September 2013
Document: Report of the Expert Group on innovation in the regulation of healthcare
Region: UK
Description: This group have been tasked with reviewing the regulation and development of healthcare innovations to identify ways to improve the licensing process. This report is the result of a year of discussions and contains a number of recommendations.
URL: click here
Date: 01 September 2012
Document: The Good Clinical Practice Guide
Region: UK
Description: MHRA has published its GCP guidelines which are intended to complement legislation and guidance already available. Commonly referred to as the “Grey Guide” the document is available to purchase via the MHRA website
URL: click here
Date: 14 August 2012
Document: ABPI Guidelines for Phase I Clinical Trials
Region: UK
Description: The ABPI has revised its guidelines for Phase I clinical trials to reflect recent changes in the regulatory environment.
URL: click here
Date: 10 October 2011
Document: Risk-adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products
Region: UK
Description: MHRA has issued guidance on risk assessment and categorisation of clinical trials. Essentially trials are classed according to risk into 3 categories, A, B and C. There is also information on potential for reduced requirements for low risk trials.
URL: click here
Date: 01 March 2011
Document: The Plan for Growth
Region: UK
Description: Following on from the AMS report on healtcare research in the UK, the government’s Plan for Growth published alongside the budget has some measures to address some of the issues raised. This includes establishing a new health research regulatory agency, with NRES at its core, addressing some of the issues around the approvals process and streamlining the way NIHR works and allocates funding. The section relevant to clinical trials begins at paragraph 2.179
URL: click here
Date: 01 January 2011
Document: Report: A new pathway for the regulation and governance of health research
Region: UK
Description: The Academy of Medical Sciences was invited by the UK government to conduct a review of health research using human subjects in the UK. The result is their report “A new pathway for the regulation and governance of health research” published in January. The report makes several recommendations to improve the UK environment for clinical trials and makes very interesting reading.
URL: click here

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