News Archive

EMA - Human Medicines Highlights Issue 172

6th September 2023

August 2023

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FDA - Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products

6th September 2023

New guidance for industry

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FDA Informed Consent - Guidance for IRBs, Clinical Investigators, and Sponsors

6th September 2023

Released August 2023

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FDA Roundup: 1st September 2023

6th September 2023

An at-a-glance summary of news from around the agency,

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MHRA - Three new UK Approved Bodies to certify medical devices announced by the MHRA

6th September 2023

TÜV SÜD, Intertek, and TÜV Rheinland UK join the four current UK Approved Bodies, almost doubling current capacity for the certification of medical devices in the UK.

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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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