Life Sciences

Recent Articles

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  11/04/2025

  Europe

  Agentic AI and the EU AI Act

  Agentic AI systems are designed to act autonomously, sense their environment, make decisions, and take actions without constant human oversight. However, their autonomy and potential to operate with minimal human intervention raise unique challenges in terms of regulation, particularly under the EU AI Act.What Is Agentic AI?The functioning of agentic AI is rooted in Large Language Models (“LLMs”) and other advanced machine learning algorithms. These models are trained on vast datasets to understand human language and respond intelligently to various inputs. What sets agentic AI...

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  11/04/2025

  Europe

  The Cyber Resilience Act: Consultation on the Technical Description Opens

  Agentic AI systems are designed to act autonomously, sense their environment, make decisions, and take actions without constant human oversight. However, their autonomy and potential to operate with minimal human intervention raise unique challenges in terms of regulation, particularly under the EU AI Act.What Is Agentic [CMS1] AI?The functioning of agentic AI is rooted in Large Language Models (“LLMs”) and other advanced machine learning algorithms. These models are trained on vast datasets to understand human language and respond intelligently to various inputs. What sets agentic...

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  07/04/2025

  United Kingdom

  The Foreign Influence Registration Scheme will go live from 1st July 2025

  The government has announced that the Foreign Influence Registration Scheme will go live from 1st July this year.The Scheme requires the registration of:Arrangements to undertake political influence activities in the UK that are directed by a foreign power (the “Political Influence Tier”); andArrangements with foreign entities for such activities as may be specified (the “Enhanced Tier”).Arrangements registered under the Political Influence Tier will, subject to some exceptions, be published on a publicly available register.A key intent behind the Scheme is to increase transparency...

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  02/04/2025

  China

  China releases draft of new working procedures for phar­ma­ceut­ic­al trial data protection

  On 19 March  2025, China’s National Medical Products Administration (NMPA) released a draft of the draft Implementing Measures for Pharmaceutical Trial Data Protection for trial implementation (covered in this previous Law-Now article). According to these Draft Measures, innovative drugs, improved new drugs, and first generic drugs can apply for a data protection period of three to six years.Alongside the Draft Measures, the NMPA also released the draft Working Procedures for Drug Trial Data Protection on the same day, serving as a companion implementation document to the Draft Measures....

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  26/03/2025

  Hong Kong

  Legal Update: The Protection of Critical In­fra­struc­ture (Computer Systems) Bill will come into effect on 1 January 2026

  The Protection of Critical Infrastructure (Computer Systems) Bill was passed by Legislative Council on 19 March 2025.  As Hong Kong’s first standalone legislation on enhancing the overall cybersecurity, it sets out a comprehensive regulatory framework and lays down the statutory requirements for the protection of computer systems within critical infrastructures, signifying an important step for aligning Hong Kong's cybersecurity practices with international standards, improving its global standing and attractiveness for international business and investment.Key Takeaways from the Bill:Establishment...

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  21/03/2025

  China

  China introduces long-awaited phar­ma­ceut­ic­al trial data protection legislation

  On 19 March 2025, China’s National Medical Products Administration (NMPA) released a draft of the Implementing Measures for Pharmaceutical Trial Data Protection (for Trial Implementation), along with its accompanying implementation procedure, Working Procedures for Drug Trial Data Protection, for public comment. These long-awaited Draft Measures outline the specific periods and scope for pharmaceutical trial data. Specifically, data protection periods will apply to the following categories of drugs :Innovative drugsA six-year data protection period will be granted from the date of the...

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