News Archive

PIC/S - Entry into force of revised GMP Annex 1

6th September 2023

The revised Annex 1 on “sterile manufacturing of the PIC/S GMP Guide entered into force on 25 August 2023 and has been published.

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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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