News Archive

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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ICH E6(R3) Good Clinical Practice workshop with Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties

15th June 2020

A virtual workshop on the renovation of the ICH guideline on Good Clinical Practice E6, further to the discussions during the March 2020 PCWP/HCPWP Joint meeting. Presentations available.

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Meeting highlights from the PV Risk Assessment Committee (PRAC)

15th June 2020

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies.

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Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3

3rd June 2020

As part of its coordinated response to the pandemic, the International Coalition of Medicines Regulatory Authorities (ICMRA) convened its regular high-level meeting of regulators from around the world on 27 May 2020 to discuss COVID-19 policies, regulatory aspects of COVID-19 medicine development and pragmatic approaches to address challenges posed by the ongoing pandemic.

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MHRA issues a scientific opinion for the first medicine to treat COVID-19 in the UK

3rd June 2020

MHRA has today given the first positive scientific opinion under the Early Access to Medicines Scheme (EAMS) for use of Gilead’s remdesivir.

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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020

3rd June 2020

Eight new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its May 2020 meeting.

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Good Laboratories Practice Symposium 2020

1st 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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DRAFT DOCUMENT FOR COMMENTS: GMP water for pharmaceutical use

27th May 2020

Open for comments, deadline 30th June 2020.

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Coronavirus (COVID-19): new dedicated Yellow Card reporting site for medicines and medical devices

26th May 2020

Reporting to the new site will enable the MHRA to rapidly identify new and emerging side effects and medical device incidents in COVID-19 treatment, including side effects for medicines taken by patients to manage long-term or pre-existing conditions.

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EMA clarifies Computer Validation and Data Integrity responsibilities in Clinical Trials

19th May 2020

The European Medicines Agency (EMA) has published a notice for sponsors of clinical trials (CTs) to highlight the requirements for the qualification and validation of computer systems used for managing CT data. This is based on recent inspection findings and takes into account implications on the integrity, reliability, robustness and acceptability of data. In line with this notice, the EMA has also updated questions 8 and 9 on EMA´s GCP Q&A website, which provide further guidance on computerised systems.

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