News Archive

MHRA - Consultation on the future regulation of medical devices in the United Kingdom

16th September 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting members of the public to provide their views on possible changes to the regulatory framework for medical devices in the United Kingdom (UK).

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MHRA - Major milestone reached in the combined review journey

16th September 2021

Major milestone reached in the combined review journey

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MHRA - Software and AI as a Medical Device Change Programme

16th September 2021

Software and AI as a Medical Device Change Programme

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MHRA launches public consultation on future of medical device regulation

16th September 2021

MHRA launches public consultation on future of medical device regulation

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MHRA - MHRA and US FDA tackle challenging data integrity

1st September 2021

The second Medicines and Healthcare products Regulatory Agency (MHRA) and US Food and Drug Administration (FDA) joint Good Clinical Practice (GCP) symposium was held in London in February 2020.

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EMA - joint HMA/EMA Big Data Steering Group workplan

31st August 2021

The joint HMA/EMA Big Data Steering Group workplan aims to increase the utility of big data in medicine regulation. A new workplan, extended to March 2023, is now available.

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MHRA - Good Pharmacovigilance Practice (GPvP) Symposium 2022

24th August 2021

Help shape the event.

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EMA - Artificial intelligence in medicine regulation

17th August 2021

The International Coalition of Medicines Regulatory Authorities (ICMRA) sets out recommendations to help regulators to address the challenges that the use of artificial intelligence (AI) poses for global medicines regulation, in a report published today.

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EMA - August 2021 CTIS Newsletter

17th August 2021

CTIS Newsletter released

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EMA - Consultation on ICH Guideline Q13 on continuous manufacturing of drug substances and drug products - Step 2b

17th August 2021

The European Medicines Agency has published for public consultation the ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 2b.

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