Earlier this week, the EMA published its Reflection paper on the use of AI in the medicinal product life cycle. As set out in our previous blog post, the EMA’s draft reflection paper was published for consultation in July
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A New 2024 Code for the British Pharmaceutical Industry – “The Future is Orange”
On 23 September 2024, the Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) published an updated Code of Practice for the pharmaceutical industry. Following an extensive consultation with over 3,000 comments, ABPI
Virtual and Digital Health Digest – September 2024
This digest covers key virtual and digital health regulatory and public policy developments during August and early September 2024 from United Kingdom, and European Union.
There have been some important reimbursement updates this month. In France, the French health regulator has
AI: EMA publishes guiding principles on the use of large language models (LLMs)
On 5 September 2024, the European Medicines Agency (EMA) and the Heads of Medicine Agencies (HMA) published a guidance document (the Guidance) with general principles and recommendations on the use of large language models (LLMs) in regulatory science and the
The European AI office and other resources relevant to high risk AI systems
In our recent blog post, we reviewed the overall impact of the new EU AI Act on the life sciences industry. The AI Act (Regulation (EU) 2024/1689), which entered into force on 1 August 2024, is the
Virtual and Digital Health Digest – August 2024
This digest covers key virtual and digital health regulatory and public policy developments during July and early August 2024 from United Kingdom, and European Union.
Following the UK national elections on July 4, 2024, which brought in a new government,
The EU AI Act: Impact on the Life Sciences Industry
Much has been written about the EU AI Act, which has now been published in the Official Journal as Regulation (EU) 2024/1689 and entered into force on 1 August 2024.
The AI Act is so-called “horizontal legislation”, meaning it
Virtual and Digital Health Digest – July 2024
This digest covers key virtual and digital health regulatory and public policy developments during June 2024 from United Kingdom, and European Union.
While it has been a relatively quiet month in the EU given elections in the European Parliament and
The King’s Speech: Product Safety and Metrology Bill
Following the outcome of the national election on 4 July 2024, on 17 July 2024, King Charles III gave a speech to the UK Parliament in which, as directed by the new Government, he outlined the key points of its
What does the new UK government mean for life sciences?
In the UK General Election on 4 July, the Labour Party won 412 of the 650 seats, giving it a comfortable majority. Its leader, Sir Keir Starmer, became Prime Minister, meaning a change of government from Conversative to Labour for