News Archive

MHRA- Guidance Released - International Recognition Procedure

31st August 2023

The MHRA has created a new international recognition route for medicines utilising pre-existing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States.

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EMA - OPEN framework extended to a wider range of medicines

2nd August 2023

EMA has expanded the scope of the OPEN initiative from COVID-19 vaccines and treatments to a wider range of medicines.

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EMA - Paving the way towards coordinated clinical trials in public health emergencies in the EU

2nd August 2023

EMA has published a report from a workshop that collected insights and suggestions for possible EU-level actions to improve the way clinical trials are set up and conducted in the European Union (EU) during public health emergencies.

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EMA - Small and Medium Enterprise Newsletter July 23

2nd August 2023

Edition 59, July 2023

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EMA/HMA - Big Data Workplan 2023-2025

2nd August 2023

HMA/EMA joint Big Data Steering Group

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FDA - Roundup: 1st August 2023

2nd August 2023

An at-a-glance summary of news from around the FDA.

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MHRA - Annual conflict of interest compliance report for 2022

2nd August 2023

Annual conflict of interest compliance report for 2022 added to the MHRA website.

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MHRA - CE marking recognition for medical devices and in vitro diagnostics

2nd August 2023

The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics.

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WHO - Public consultation on WHO guidance for best practices for clinical trials

27th July 2023

In May 2022, the Seventy-fifth World Health Assembly adopted a resolution on Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination, in which one action requested of the Director-General was to develop WHO guidance on best practices for clinical trials. Please see action 2 under section “Requests the Director-General” at the end of WHA 75.8 resolution here. WHO is launching a public consultation on draft guidance developed in line with this request.

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EMA - CTIS Newsletter July 2023

20th July 2023

EMA is pleased to share that the 15th issue of the ‘Clinical Trials Highlights’ newsletter has been published. The newsletter provides insights on clinical trials topics, including on the ACT EU initiative and CTIS.

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