News Archive

EMA - CTIS Newsflash, March 2023

15th March 2023

With the aim to enhance communication with the CTIS user community, this regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.

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EMA - Human Medicines Highlights Newsletter, March 23

15th March 2023

Key information for patients, consumers and healthcare professionals - Published monthly by the European Medicines Agency

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FDA - Q13 Continuous Manufacturing of Drug Substances and Drug Products

15th March 2023

FDA issued final guidance.

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MHRA - Advisory Group Reform Proposals

15th March 2023

Update to the Life Sciences Council Joint Statement on Medical Devices Regulatory Reform.

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MHRA - Fees Update

15th March 2023

MHRA fees for 2022 - 2023 are remaining the same as 2021 - 2022.

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MHRA - Laboratories that are members of the UK GLP Compliance Monitoring Programme

15th March 2023

List updated 14 March 2023

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MHRA - List of Accredited Phase I Units

15th March 2023

List updated 15th March 2023

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MHRA - Patient Involvement Strategy: One Year On

15th March 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) published its Patient Involvement Strategy in October 2021. This defined how we will engage and involve the public and patients in our work.

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MHRA Blog - Reflections on the shared commitment to public involvement

15th March 2023

Blog post by Caroline Barker-Hurden, Posted on 13th March 2023

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MHRA Blog Post - Large Language Models and software as a medical device

6th March 2023

Large Language Models (LLMs), including ChatGPT and Bard, offer great potential to mimic human conversation. LLMs only directed toward general purposes and whose developers make no claim that the software can be used for a medical purpose are unlikely to qualify as medical devices.

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