News Archive

MHRA and FDA Joint Paper 'Data Integrity in Global Clinical Trials'

30th June 2020

Following on from the successful 2-day event in Washington in October 2018 where MHRA GCP Inspectors (Gail Francis, Steve Vinter and Andy Fisher) and US FDA joined forces to discuss data integrity, MHRA and FDA have produced a joint paper ‘Data Integrity in global Clinical Trials’ authored by those who presented at the event.

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EMA - Academia fee waiver for scientific advice

23rd June 2020

The EMA is pleased to inform you about the decision to waive all fees for scientific advice for academic researchers developing orphan medicines, to further encourage the development of treatments for rare diseases.

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EMA - Pharmaceuticals – safe and affordable medicines (new EU strategy)

23rd June 2020

About this initiative: Summary The EU is launching a new strategy to improve and accelerate patients’ access to safe and affordable medicines and to support innovation in the EU pharmaceutical industry. It will address: • the life cycle of medicines from R&D to authorisation and patient access • how to put scientific and technological advances into practice • how to fill market gaps (e.g. new antimicrobials) • lessons learnt from COVID-19 on how to better prepare for future pandemics. Topic: Public health Type of act: Communication Category: Commission Work Programme

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Have your say on the future development of ISO 9000 and ISO 9001

23rd June 2020

The current editions of ISO 9000, Quality management systems Fundamentals and vocabulary, and ISO 9001, Quality management systems Requirements, were published in 2015. Both standards will shortly be up for a systematic review as required by the ISO Directives. The choices available for what happens to the standards are: Confirm, Revise/Amend, Withdraw, or Abstain.

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ISO 9001 Auditing Practices Group Guidance on: REMOTE AUDITS

23rd June 2020

Remote auditing is one of the audit methods described in ISO 19011:2018 Annex A1. The value of this audit method resides in its potential to provide flexibility to achieving the audit objectives. In order to realize the benefits of this audit method, all interested parties should be aware of their role in the process, inputs, expected outputs, and risks and opportunities that will provide the basis to achieve the audit and audit program objectives.

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Survey assessing the Member States’ rules on health data in the light of GDPR

23rd June 2020

Request for comments from EMA.

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Opportunities for patients and the public to be involved in the work of the MHRA

17th June 2020

How the MHRA engage and involve patients and the public in our regulatory decision-making. Updated 15th June 2020.

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Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice

17th June 2020

FDA/CTTI Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice - meeting materials

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Good Clinical Practice Symposium 2020

16th June 2020

Between 11 and 14 February 2020, the MHRA hosted a week-long series of events as part of the Good Practice Symposia Week. This included individual events from the GPvP, GCP and Laboratories Inspectorates where a host of regulators and delegates from across the globe came together.

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Guidance on remote GCP Inspections - 10th June 2020

15th June 2020

Guidance on remote GCP inspections during the COVID19 pandemic This document is intended to provide guidance on the steps to be followed during remote good clinical practice (GCP) inspections.

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